Expanded Access Program for gallium maltolate (GaM) Now Open

Investigational cancer treatment with the potential to slow brain tumor growth is now available for patients with relapsed/refractory glioblastoma.

xCures, a healthcare data platform provider, announced that the US Food and Drug Administration (FDA) has approved an Expanded Access Program (EAP) for gallium maltolate (GaM), a new cancer therapy.

Sponsored by Imaging Biometrics, this program was set up specifically for patients with relapsed/refractory histologic or molecular glioblastoma, who have no other standard treatment options available.

The EAP is open to physicians whose patients have exhausted standard-of-care therapies, fit the eligibility criteria, and cannot access the open-enrolling phase I clinical trial for the investigation of GaM.

“This Expanded Access program will help bring GaM to patients in need while carefully monitoring patients and gathering data that will inform and improve future cancer therapies,” said Mika Newton, CEO of xCures. “Our commitment at xCures is to bridge the gap between clinical trials and patient care by harnessing the power of Real-World Evidence, which is a key step this initiative will help drive forward.”

“The opening of this EAP marks a significant milestone in our mission to combat glioblastoma,” said Michael Schmainda, president and CEO of Imaging Biometrics. “With gallium maltolate now available through the Expanded Access program, we can provide a new therapeutic option to patients who have exhausted all other avenues, offering hope and potentially extending life. Our dedication remains to advancing research and delivering solutions that can make a real difference in the fight against cancer.”

Physicians and patients can find more information about this program (NCT06404034) and how to request access at www.xcures.com/gam.

About gallium maltolate (GaM):

GaM is a novel gallium formulation that differs from gallium nitrate, a first-generation FDA-approved gallium compound that has been extensively studied in preclinical and clinical studies. The difference between GaM and gallium nitrate is that GaM has greater anti-tumor activity than Ga nitrate and can be taken orally rather than through iv administration. GaM has demonstrated promising early efficacy for patients with various malignancies.

About Expanded Access:

Expanded access is the treatment use of an unapproved drug under special forms of investigational new drug applications (IND) outside of a clinical trial by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.

About the Program:

This Expanded Access program is intended to provide GaM for compassionate use in glioblastoma patients who have exhausted available therapies. The program aims to collect sufficient information about the patient’s treatment to provide a complete and accurate case report to health authorities including patients’ response and duration of response using real-world data, analysis of imaging results, an assessment of GaM safety and tolerability, and the effect of GaM treatment on patient/caregiver reported functional status and quality-of-life.

About xCures:

Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate patients care. For more information, contact info@xcures.com or visit http://www.xcures.com.

About Imaging Biometrics:

Imaging Biometrics is a wholly owned subsidiary of IQ-AI Limited, (LON: IQAI), and focuses on delivering quantitative imaging platforms and therapeutics that transform how clinicians diagnose and treat patients more efficiently and effectively. For more information about Imaging Biometrics, visit the company’s website at www.imagingbiometrics.com. Follow IB on Twitter, @IQAI_IB.

Clarified Precision Medicine and xCures Form Strategic Partnership to Transform Patient Outcomes Through Precision Oncology

Collaboration will focus on analyzing and improving guidelines-based utilization of precision medicine to better support oncologists and cancer patients. Alliance will bring together powerful analytics alongside the very best AI-driven precision oncology medical expertise.

Clarified Precision Medicine, the only company that provides oncologists with prioritized therapy options via a combination of expert medical provider review and underlying artificial intelligence (AI) computational algorithms, and xCures, a healthcare technology company that delivers real-time clinical data to power precision medicine support, today announced a strategic partnership to dramatically advance the field of precision oncology.

The two companies will come together to enhance cancer care delivery and personalized patient treatment recommendations through precision medicine and data-driven analysis. The goal of the alliance is to better identify and understand current gaps in providing precision medicine and ultimately improve patient outcomes.

Oncology faces an immediate need to improve access to precision medicine. In the United States, there are 18 million patients with a history of cancer and 1.9 million new cancer diagnoses each year. Patients who receive precision therapies have survival rates that are three times greater than those who do not. However, 75 percent of doctors say they need help interpreting the genomic tests that make precision medicine possible —which in turn leads to more effective utilization of these powerful 21st-century tools.

To that end, Clarified and xCures will collaborate on patient-level data analytics, and also work together to improve provider support, education, and communication. The two organizations will develop learning systems focused on innovative solutions in precision oncology, such as predictive analytics and treatment optimization.

Clarified will contribute its specialized treatment recommendation system to the partnership, which combines insights from experienced medical professionals with support from its AI-driven treatment algorithm. The company’s team of expert medical reviewers will provide clinical oversight. xCures will provide its AI-driven technology platform, which excels at extracting the critical information needed for care among the complex cancer patient data and enhancing access to medical records. 

“This partnership unites two of the most innovative leaders in the field of precision oncology,” said Clarified Precision Medicine CEO Rajni Natesan, MD MBA. “Clarified is the leading expert in closing gaps at the last mile of precision oncology, with an AI platform and the greatest understanding of physician needs and individual patient outcomes. xCures is a leader in data and technology that transforms clinical efficiency and patient care. This powerful alliance enables us to overcome obstacles in cancer care that can only be addressed by an advanced, data-driven understanding of oncology at the patient level.”

“We are excited to partner with Clarified Precision Medicine to harness the power of real-time clinical data and advanced analytics,” said xCures CEO Mika Newton. “This collaboration will enable us to deliver highly personalized and effective treatment recommendations, ultimately improving patient outcomes in precision oncology. By combining our strengths, we can address the critical need for better access to precision medicine and support oncologists in making data-driven decisions that enhance patient care.”

In addition to improving the utilization of precision medicine, the alliance will have significant capabilities in data collection and analytics to drive precision oncology research. The technology integration between Clarified and xCures will facilitate retrospective and prospective data analysis to improve treatment strategies and patient care outcomes.

About Clarified Precision Medicine

Clarified Precision Medicine is the first scalable molecular tumor board with a combination of an AI-based platform plus medical group, offering expert clinical somatic and pharmacogenomics consultations through its ClarifiedSelect™ and OncoGuardian™ solutions. Clarified accelerates the delivery of guidelines-based genomic insights to patients and providers by bringing together nationally recognized experts in medical oncology, oncology pharmacy, data integration, and molecular pathology who have over 100 years of collective experience in the application of precision oncology. For more information, visit: www.clarifiedprecisionmedicine.com

About xCures

Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com.

Kidney Cancer Association enters strategic partnership with xCures

The partnership will empower patients with greater control over their health data and accelerate the discovery and approval of new treatments for kidney cancer.

The Kidney Cancer Association (KCA) has partnered with xCures, the AI-driven medical record aggregator and research company, to offer kidney cancer patients the opportunity to contribute to research through clinical trials.

Together, KCA and xCures will create an Observational Research Platform where patients can consent for their medical records to be gathered, de-identified, and organized for analysis.

Researchers collaborating with the KCA may access this unique database of real-time, regulatory-grade clinical data to support their work.

“This partnership represents a significant step forward in leveraging real-world data to accelerate the development of effective treatments for kidney cancer,” said Mika Newton, CEO of xCures. “By integrating patient records and making this comprehensive data available to researchers, we are fostering an environment where insights can be rapidly transformed into actionable therapies.”

This resource may help researchers understand which treatments show the most promise for kidney cancer patients, potentially speeding up the regulatory and approval process.

Patients who participate, as well as their providers, can also use the xCures portal to access their medical records and a care summary incorporating information from all care-providing institutions. This comprehensive summary can be shared with care providers for treatment option discussions and better decision-making.

xCures’ clinical data technology may also help patients and their providers to identify optimal treatment options and potentially match them with appropriate clinical trials.

“We are excited to partner with xCures to provide an excellent new service to patients for curated, easy-to-understand access to their health information,” said Dr. Salvatore La Rosa, KCA’s Chief Scientific Officer. “In addition, for the first time, this collaboration allows us to access real-world data, enabling us to generate evidence and determine care gaps for people with kidney cancer.”

The KCA/xCures partnership builds on xCures’ expertise in real-world oncology data and represents a joint effort to support both patients and researchers to advance kidney cancer treatment, science and pursue cures.

# # #

About xCures
Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners.

About the Kidney Cancer Association
The Kidney Cancer Association is a global community dedicated to serving and empowering patients and caregivers, and leading change through advocacy, research, and education in order to be the universal leader in finding the cure for kidney cancer. Founded in 1990 by Eugene P. Schonfeld and a small group of patients and doctors in Chicago, Illinois, the KCA has grown into an international non-profit organization based in Houston, Texas. The KCA promotes scientific advances through two annual research symposiums and a robust grant program, participates in legislative advocacy, and seeks to be a source of education and resources for patients, caregivers, and anyone impacted by kidney cancer.

xCures to showcase the value of its healthcare data platform at the 2024 ASCO Annual Meeting

xCures’ patient-centric platform enables outcomes monitoring and evidence generation, providing insights into the best treatments, including for rare cancers.

xCures, a leading-edge healthcare technology company, is pleased to announce the presentation of two abstracts at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024, to be held May 31 – June 4, at McCormick Place, Chicago, IL, USA.

The two abstracts illustrate the value of xCures’ real-time healthcare data platform. The platform’s enhanced longitudinal nationwide data goes beyond traditional retrospective real-world data, allowing for analysis of electronic medical records from partnerships with sites of care nationwide. Through its platform and patient- and observation-driven real-time datasets, xCures helps partners learn from complex and multidisciplinary therapeutic approaches to provide valuable insights to improve outcomes.

“Access to real-time, longitudinal, uninterrupted clinical data offers an unparalleled capacity to extract insights from patient medical records,” said Tim Stuhlmiller, Vice President of Scientific and Medical Affairs at xCures. “These abstracts showcase the importance of our partnerships and our platform’s incredible power to analyze outcomes and support evidence-based decisions, resulting in improved patient care.”

In one work, xCures and their partner Genome Medical, a nationwide telehealth provider of genetic services, analyzed data from patients with germline genetic testing followed by genetic counseling, including cancer risk assessment. The platform generated structured clinical data from multiple care sites to determine the percentage of patients who underwent bilateral mastectomies after receiving genetic testing and genetic counseling from Genome Medical. This is one of the first studies to use multi-institution real-world data to assess the impact of genetic counseling and genetic testing.

Half of the patients with a genetic test result that indicated bilateral mastectomy elected to have a mastectomy done after discussing this guideline-based care option with a Genome Medical genetic counselor. As evidenced in prior research, bilateral mastectomy markedly reduces the risk of breast cancer.

“Access to longitudinal records across multiple care sites allowed us to more thoroughly assess how genetic counseling and genetic testing increase the uptake of guideline-recommended cancer prevention services,” said Colleen Caleshu, Senior Director of Clinical Research at Genome Medical. “Our goal is to make genetics clinically actionable so patients can make more informed decisions about their health. By working with xCures, we are able to gain better insights into those decisions and the impact they have on the patients we serve.”

In the other abstract, xCures partnered with the FibroFighters Foundation to better understand the landscape of real-world treatments for Fibrolamellar carcinoma (FLC) by tracking treatments, molecular profiling, and outcomes. This is essential for such a rare form of liver cancer without an established standard of care.

Patients with FLC undergo extensive molecular profiling with multiple novel therapeutic regimens employed in real-world practice. Raw imaging scans are being aggregated for central radiological review to measure the depth and duration of response offered by the recorded therapeutic strategies. This dataset is a rich resource for academic and government researchers to fuel research and define optimal treatment modalities. Topline statistics for the dataset are available at https://xcures.com/flcdashboard/.

“xCures has done what no one else has been able to do for rare diseases, specifically for Fibrolamellar Carcinoma,” said Paul Kent, MD, Medical Director of the FibroFighters Foundation. “We have the largest interactive, real-time scientific database of FLC ever collected, allowing doctors from 15 countries and 27 institutions to discuss their cases with expert FLC panelists of oncologists, surgeons, radiation oncologists, interventional radiologists, and patient advocates. xCures has driven the most important advances in clinical research for FLC ever.”

Attendees of the ASCO Annual Meeting are encouraged to find Mika Newton, Max Goldstein, Tim Stuhlmiller, or Artem Petrov from xCures, who can provide in-depth insights, discuss potential collaborations, and showcase case studies from the platform’s implementation.

The abstracts presented:

Use of a nationwide, patient-powered observational platform to define the landscape of treatment, molecular profiling, and outcomes for fibrolamellar carcinoma.
Authors: Paul Kent, Alaa Awawda, Hiba Kouser, Alanis Sabates, Zachariah Cole, Mark Shapiro, Tom Stockwell, Timothy Stuhlmiller

https://meetings.asco.org/abstracts-presentations/235938

and,

Leveraging real-world data from multiple institutions to assess the rate of bilateral mastectomy after cancer genetics evaluations with genetic counselors.
Authors: Ashley Daley, Callan Russell, Timothy Stuhlmiller, Zachary Kaufman, Jill Davies, Colleen Caleshu

https://meetings.asco.org/abstracts-presentations/231790

About xCures

Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes to offer a sophisticated view of a patient’s fully longitudinal health journey, which encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com.

xCures Announces Issuance of Groundbreaking Patent

USPTO awards patent for AI tech enabling virtual trials, enhancing clinical decisions through continuous learning from patient experiences.

OAKLAND, CA — xCures, Inc., a leader in health technology, is proud to announce that the U.S. Patent and Trademark Office (USPTO) has officially issued Patent No. 11,887,738, a landmark achievement in biomedical decision-making. This patent marks a significant milestone in the company’s journey to transform the value of healthcare data using artificial intelligence (AI) and deliver on the promise of precision medicine.

The newly patented technology, titled “Platforms for Conducting Virtual Trials,” introduces a novel platform for capturing clinical cases and expert-derived treatment rationales using AI to facilitate biomedical decision-making, which can include virtual clinical trials that continuously learn from the experiences of all patients, on all treatments and all the time. Algorithms such as Bayesian machine learning methods can be applied to coordinate such virtual trials. This invention demonstrates xCures’ vision for transforming US healthcare data into continuous, real-time, regulatory-grade data that can improve care, drive innovation, and accelerate the development of new treatments.

“We’re incredibly excited about this patent. The USPTO recognized our innovative work in AI-enabled learning systems using medical records plus AI to create patient case summaries, using natural language processing to create knowledge bases that support treatment selection, leveraging machine learning for personalized treatment recommendations, incorporating expert human feedback to refine algorithms, and continuous improvements via calibration from real-world outcomes data. It is just the first of many patent-pending innovations in our pipeline,” said Mark Shapiro, Chief Operating Officer at xCures.

With the issuance of this patent, xCures solidifies its position at the forefront of health data and technology. The company is dedicated to leveraging this patented technology to enable stakeholders across the healthcare continuum to implement platforms that collect, aggregate, organize, and structure healthcare data.  This approach enables continuous learning from the treatment of all patients using an AI-based platform.

The patent can be found here.

About xCures

Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com.

xCures Unveils Expanded AI Health Data Platform: Now Supporting All Therapeutic Areas and is Available as SaaS

The company’s platform expansion transforms the value of US healthcare data by harnessing real-time, regulatory-grade data in any therapeutic area to efficiently understand the complex medical histories of patients and drive research through detailed, longitudinal datasets.

OAKLAND, CA – January 31, 2024 xCures, a trailblazer in healthcare technology, announced today the expansion of its AI-assisted medical data platform to support real-time, regulatory-grade data in any therapeutic area. Originally designed as a tool focused specifically on cancer, the company’s platform expansion now serves as a comprehensive tool to collect and understand medical records for any US patient with any condition.

Harnessing AI/ML technology, xCures’ platform gathers records, extracts, and aggregates data, including organizing and structuring clinical, genomic, and imaging information from diverse sources, into a searchable digital record. This solution can help any user looking to quickly find or assess key clinical information about a patient for care-related activities. This integrated approach transforms how medical professionals and researchers can understand complex patients and cohort characteristics

xCures makes this technology available through software licenses to the platform and direct API connections embedded within existing healthcare workflow management platforms.  The system offers a patient-centric, longitudinal perspective crucial for informed decision-making.  

This evolution marks another advancement that will significantly benefit those making data-driven healthcare decisions.  Because the collected data can also be de-identified it can be be available for secondary research;  xCures provides the most comprehensive patient-centric longitudinal data in the form of deidentified real-world datasets that contain comprehensive insights across all providers and care locations. 

“Expanding our AI platform beyond oncology marks a significant milestone in our mission to transform the value of healthcare data,” said Mika Newton, CEO of xCures. “We’re providing access to a software platform that generates precise real-world data at the individual and cohort levels across all diseases that will accelerate groundbreaking research across many fields and directly benefit patients. ”

With its ability to aggregate and interpret diverse medical records quickly and accurately, xCures’ platform is a game-changer for anyone working to access and interpret retrospective and prospective healthcare or real-world data. It facilitates an in-depth understanding of medical patterns and conditions and enhances the scope of clinical trials and research across various diseases. Making this technology available across the healthcare ecosystem as a platform solution transforms the opportunity to leverage US healthcare data.

For more information, visit https://xcures.com/ 

About xCures

Launched in 2018, xCures Inc. operates an AI-assisted platform that automatically retrieves and aggregates medical records from any US care site. Data is extracted and structured within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com or visit http://www.xcures.com.

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xCures and Aetion® Further Enhance Partnership with Rich Real-World Datasets

Partnership now includes access to five comprehensive oncology datasets, enhancing real-world evidence in cancer research.

In the realm of oncology research, diverse, comprehensive, and fully longitudinal datasets are invaluable. They offer a granular view of patient journeys throughout the US, enabling researchers to draw clinically relevant insights.

These comprehensive datasets are crucial for advancing personalized treatment strategies and improving patient outcomes in cancer care.

The challenge in current oncology outcomes research lies in the fragmentation of patient data across numerous healthcare providers and sites of care. This creates significant gaps in understanding patient outcomes and treatment efficacies. The scattered data landscape hinders the development of robust real-world evidence (RWE) necessary for impactful cancer research.

xCures consolidates and structures clinical, genomic, and imaging data directly from patients’ electronic medical records, healthcare providers, and other sites of care along the patient’s care journey.

The broad, longitudinal, patient-centric view enables researchers and clinicians to access up-to-date and comprehensive information, paving the way for more informed and timely treatment decisions.

In addition to contributing data to support Aetion’s collaboration with the Food and Drug Administration, the new partnership enables Aetion®, a global leader in RWE and analytics, to incorporate xCures’ breast cancer, glioma, melanoma, colorectal cancer, and ovarian/uterine cancer datasets into their Accelerated Access Oncology Program.

“We’re thrilled about this partnership with Aetion,” said Mika Newton, xCures CEO. “It’s a testament to the power of collaborative efforts in advancing oncology research. By bringing our real-time, regulatory-grade, clinical data (RRC) to a broader audience, we’re not just sharing information – we’re empowering a shift towards more effective, patient-centric cancer treatments.”

Wendy Turenne, Senior Vice President, Real World Data & Operations at Aetion, said: “We are delighted to partner with xCures, as their datasets provide a unique lens into the patient’s experience. In combination with Aetion® Substantiate, these data can be analyzed in novel ways and shorten the time to generate and deliver critical insights that will help shape the future of cancer treatment.”

Contact us today for more information on how this partnership can empower your research and development strategies.

About xCures

Since 2018, xCures Inc. has operated an AI-assisted platform that automatically retrieves and aggregates medical records from all US care sites. Data is extracted and structured within 15 minutes to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures provides clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com, or visit http://www.xcures.com.

About Aetion®

Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. Aetion’s suite of real-world data analytics applications analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us at @aetioninc.

xCures to offer clinical data extraction as a service in AWS Marketplace

AWS cloud configurations will help xCures customers to leverage the company’s robust data gathering and structuring services while maintaining secure, private ownership of their data.

xCures, a trailblazer in healthcare technology is proud to offer its platform as a clinical data extraction service in AWS Marketplace, a digital catalog with thousands of software listings from independent software vendors that make it easy to find, test, buy, and deploy software that runs on Amazon Web Services (AWS).

The xCures platform is a real-time clinical data and evidence-generation tool. It is designed to securely collect complete, longitudinal medical records from virtually all US sites of care. Further, the platform automates the processing of patient records into both standardized, structured datasets (i.e., the most commonly requested FHIR format resources) and semantic interpretations of patient cases.

The Platform can gather data across care settings (including sendout labs), even when subjects change providers, insurance plans, or locations. The data is structured into de-identifiable, tokenizable representations desired by industry and stored in xCures’ multi-tenant data and evidence generation private cloud platform. This allows clients to transition from having data rights to having data assets.

All structured data is completely source-verifiable (i.e., can be traced to a clinical record) and can be gathered (or refreshed) and analyzed in minutes. The Platform is also equipped with cutting-edge Natural Language Processing (NLP) technology to assist human annotation. This ensures that output data is primed for specialized analyses or applications, even when there are custom abstraction requirements.

Mika Newton, CEO of xCures, expressed his enthusiasm about the AWS Marketplace listing, stating, “By aligning with AWS, we’re reaffirming our commitment to offering clients enhanced security and scalability. By leveraging the power of AWS, our clients can be confident that their data remains shielded by the finest digital and physical security mechanisms.”

This latest offering is a testament to xCures’ unwavering dedication to revolutionizing healthcare data accessibility, management, and security. With the Cures Platform in AWS Marketplace, the future of clinical data use looks brighter than ever.

Visit xCures’ listing in AWS Marketplace to get started; or learn more about xCures and AWS here.

About xCures

Since 2018, xCures Inc. has operated an AI-assisted platform that automatically retrieves and aggregates medical records from all US care sites. Data is extracted and structured, within 15 minutes, to offer a sophisticated view of a patient’s fully longitudinal health journey that encompasses everything from genomics to social determinants of health.

Through a variety of tools and data products, xCures can provide clinically actionable, real-time insights that facilitate clinical research and care for patients, providers, and partners. For more information, contact info@xcures.com.

xCures Partners with the Pancreatic Cancer Action Network (PanCAN)

xCures offers unparalleled access to data and the xINFORM patient portal to accelerate pancreatic cancer research and improve patient care

OAKLAND, CA – xCures, a leader in real-time clinical data technology, is thrilled to announce a pivotal partnership with the Pancreatic Cancer Action Network (PanCAN).

As part of the agreement, PanCAN’s researchers and grantees will have unparalleled access to xCures’ deidentified Real-time, Regulatory-grade Clinical data. 

This collaboration aims to drive innovations and breakthroughs in pancreatic cancer research by harnessing the power of real-time patient data. xCures database boasts fully longitudinal clinical data from thousands of pancreatic cancer patients, including over 25,000 locations and ~4,000 medical records per patient.

The benefits of this partnership extend beyond the research community. xCures is making their xINFORM patient portal available to PanCAN’s leading Patient Services program.

The state-of-the-art portal aggregates and centralizes patients’ medical records and structures them into a computable format and an easy-to-understand longitudinal timeline. 

The xINFORM portal supports patients in being matched with suitable treatments and clinical programs, obtaining invaluable second opinions.

Sudheer Doss, Ph.D., Chief Business Officer of PanCAN, shared his enthusiasm for the partnership: “We’re always in search of innovative ways to serve our patient community better and accelerate pancreatic cancer research. As part of the comprehensive free services we offer through our PanCAN Patient Services program, this platform can pave the way for identifying optimal treatments and ensuring that our patients receive the best care possible.”

The PanCAN-xCures partnership blends the strengths of both organizations to advance patient outcomes and bolster research capabilities.

“We at xCures are deeply committed to placing patients at the forefront of all our endeavors,” said Mika Newton, CEO of xCures. “This new partnership with PanCan is a testament to our dedication to advancing patient-centric solutions and strengthening our bond with patient advocacy organizations. Together, we will usher in a brighter, more hopeful future for all.”

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. 

The (unstructured) data is aggregated and organized into a powerful, up-to-date care summary that helps cancer patients get the right therapy at the right time. 

The platform’s portals, xINFORM for patients and xDECIDE for providers, facilitate treatment option decisions. 

The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. 

For more information, contact info@xcures.com or visit http://www.xcures.com.

About PanCAN

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive. For 18 years in a row, PanCAN has earned a Four-Star Rating from Charity Navigator – the highest rating an organization can receive. This rating designates PanCAN as an official “Give with Confidence” charity, indicating strong financial health, ongoing accountability and transparency.

xCures Platform advances progress on the White House Cancer Moonshot mission to end cancer as we know it.

New study will collect, organize, and share data for Diffuse Midline Glioma (DMG) and Diffuse Intrinsic Pontine Glioma (DIPG) research.

xCures, a leader in data-driven cancer solutions, is thrilled to announce that its platform has been highlighted as a new commitment to deliver progress on the mission of the White House Cancer Moonshot – ending cancer as we know it.

The xCures health-data technology platform has been designed to overcome a key challenge for many rare diseases: collecting, organizing, and standardizing comprehensive data from patients across the US.

In alignment with the Cancer Moonshot Initiative’s goals to reduce cancer death rates by 50% over the next 25 years, xCures is launching an ambispective natural history study of DMG and DIPG. This study will speed up the identification of patterns that can inform more personalized treatment plans and targeted therapies.

xCures will provide access without licensing fees to the data for academic and government researchers. Open access to this valuable resource will accelerate scientific breakthroughs and foster a community actively seeking a cure.

“We recognize that collaboration is key to success. Our pledge extends to fostering an ongoing relationship with all stakeholders – patients, families, physicians, researchers, and advocacy organizations,” said Mika Newton, CEO of xCures. “Together, we can create a powerful collective dedicated to advancing the understanding and treatment of DMG DIPG.”

DMG and DIPG patients are encouraged to sign up for the study at www.xcures.com/dmg

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time.

The platform’s portals, xINFORM for patients and xDECIDE for providers, facilitate treatment option decisions. The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com

xUTILITY to Lead the Way Integrating Research and Patient Care

Seamless integration with existing healthcare infrastructures drives unprecedented possibilities to improve medical research and patient care.

xCures, a trailblazer in healthcare technology, is delighted to unveil xUTILITY, a solution poised to transform the patient registry paradigm in the United States.

xUTILITY establishes an instantaneous patient registry platform by retrieving records nationwide and automatically digitizing and structuring the electronic health data into a common data model with AI-enhanced abstraction and source verification, as needed.

In order to provide a 360-degree view of patient health, xUTILITY includes comprehensive capture capabilities for Electronic Health Records (EHR) and Social Determinants of Health (SDOH) data.

“The integration of research and care is the future of healthcare,” said Mika Newton, CEO of xCures. “xUTILITY brings this future to the present by delivering rich, comprehensive, and timely patient data. This connectivity will spur personalized, efficient care and groundbreaking medical discoveries.”

The platform’s ability to capture Real-Time, Regulatory-Grade Clinical Data (RRC) is pivotal to delivering quality patient care and pursuing groundbreaking medical research. 

xUTILITY’s distinctive feature is its ability to accommodate user document uploads, integrated with automated data extraction. 

The resulting synchronized data architecture introduces a new era of research-driven patient care. Its innovative data extraction process, bolstered by a complete data annotation workflow, adheres to 21 CFR Part 11, signifying xCures’ unyielding commitment to data integrity.

The unprecedented level of automation offered by xUTILITY translates to a remarkable workforce multiplier, with up to a 30-fold improvement in efficiency of data curation. This efficiency enables healthcare organizations to expedite decision-making, improve health outcomes, and enhance operational effectiveness.

With xUTILITY, xCures is charting a course toward a future where the integration of research and care forms the backbone of healthcare delivery.

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time.

The platform’s portals, xINFORM for patients and xDECIDE for providers, facilitate treatment option decisions.

The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com.

xCures to Contribute Data to Support Aetion®’s Collaboration with FDA

xCures data deemed fit-for-purpose to address research questions relevant to the prevention, clinical care, diagnostics, and treatment in oncology.

First posted on NewsDirect

In a step forward for healthcare research, xCures is pleased to announce that it will support Aetion®’s collaboration with the US Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). As part of this partnership, xCures will provide Aetion with data to support their research collaboration agreement with OCE which centers on using real-world data (RWD) to assess real-world oncology endpoints and measure and address health disparities.

As part of the collaboration with OCE, Aetion’s comprehensive fit-for-purpose data assessment identified xCures’ real-time, regulatory-grade data platform to be an appropriate fit for this research study, particularly its ability to integrate clinical data with patient pathology, radiology reports, and imaging assessments.

“Aetion is proud to embark on this partnership with xCures to help OCE conduct pivotal research to advance the use of real-world evidence, including in measuring and understanding vulnerable and underrepresented populations,” said Liz Garry, Head of Scientific Research, Aetion. “This work furthers our mission to power critical decisions in healthcare with data science-driven technology and brings us one step closer to achieving health equity.”

xCures’ CEO, Mika Newton, explains, “Our platform’s automated organization and structuring of aggregated, continuous data result in complete, source-verifiable, and fully longitudinal clinical data sets. This rich dataset can offer unprecedented insight into the real-world patient experience.”

The contribution of robust RWD from xCures will play an integral role in this endeavor, aiming to fill knowledge gaps and facilitate advancements in healthcare research. For more information about real-time, regulatory-grade clinical data, please visit www.xcures.com/solutions.

About Aetion®
Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us on LinkedIn.

About xCures
xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time.
The platform’s portals, xINFORM for patients and xDECIDE for providers, facilitate treatment option decisions.

The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials.

xCures and DDRFA partner to make an impact on patient-driven DIPG & DMG research

xCures’ technology harnesses real-time patient data and makes it accessible for scientific exploration and to improve patient options.

Today, xCures and the Diffuse Intrinsic Pontine Glioma (DIPG) / Diffuse Midline Glioma (DMG) Research Funding Alliance (DDRFA) are proud to announce their partnership, a collaboration focused on leveraging real-time patient data to drive forward DMG (including DIPG) scientific study and patient care options.

Through this collaboration, xCures aims to streamline DMG research and enhance patient care by centralizing the collection and analysis of anonymized DMG patient data. By enhancing scientific discovery while upholding patients´ and doctors´ stringent privacy and security standards, this partnership will significantly advance patient-driven research and treatment options.

“We’re incredibly excited to join forces with xCures,” said Lisa Ward, coordinator for DDRFA. “Through this collaboration, we’re leveraging cutting-edge technology to elevate DIPG and DMG research. Our vision is to learn from every patient in real-time, aggregate this vital data, and make it accessible for further scientific exploration. Equally as important, is to structure data to be widely accessible to academic researchers and industry poised to bring discoveries in this nearly universally fatal childhood cancer.”

xCures, renowned for its technology solutions in oncological clinical research, will provide a secure platform for data gathering and analysis. Their unique ‘Privacy by Design’ approach ensures patient data privacy, a crucial element of this partnership, and thus facilitates the creation of an extensive, dynamic dataset that reflects the real-world experiences of DMG patients. Moreover, the dataset’s continuous updates will offer researchers timely insights into treatment responses, symptom progression, and patient outcomes.

“Collaborating with DDRFA will permit us to apply our technology towards a critically important cause,” commented Mika Newton, the CEO of xCures. “We believe this partnership will have a crucial role in advancing DIPG and DMG research, and ultimately improving patient care.”

By fostering a more profound understanding of DIPG, xCures and DDRFA strive to spark scientific breakthroughs and inform treatment decisions, significantly improving the prognosis for patients living with this devastating disease.

Patients and caregivers that want to help and leverage the power of this collaboration are encouraged to visit www.xcures.com/dmg

About DDRFA
DDRFA is a leading not-for-profit alliance of over 60 separate foundations and funds dedicated to the research and advocacy of Diffuse Intrinsic Pontine Glioma (DIPG) and Diffused Midline Glioma (DMG). Its mission is to drive forward scientific understanding and treatment options for DIPG and DMG through fostering collaborative research efforts and increasing public awareness. DDRFA is coordinated by Tough2gether Foundation. Many of its member organizations are founded by families in memory of children lost to DIPG and DMG. Together the members fund cutting-edge research because they know well that young lives depend on them. For more information, visit www.ddrfa.org

About xCures
xCures Inc. operates an AI-assisted platform that offers patients and oncologists access to all their medical records, irrespective of where they were treated, an always up-to-date comprehensive Care Summary, and a Treatment Options Report. This service is free and designed to help all cancer patients get the right therapy at the right time.

The fully longitudinal (unstructured) patient clinical data is aggregated and organized for use by life sciences professionals in studies and decentralized trials. For more information, visit www.xcures.com

CureMatch and xCures Partner to Revolutionize the Standard for Precision Cancer Treatment Processes

CureMatch will leverage the xCures technology that automatically creates a comprehensive outline of a cancer patient’s medical history in order to improve treatment recommendations.

CureMatch, Inc., a healthcare technology company that leverages artificial intelligence (AI) to power precision medicine support for oncology, is proud to announce a partnership with xCures, Inc., to connect cancer patients and physicians with optimal investigational or approved therapies. CureMatch will leverage the xCures technology platform to create a comprehensive outline of a cancer patient’s medical history and further enhance its precision cancer treatment recommendation capabilities.

CureMatch analyzes an individual patient’s genetic sequencing report to determine which drug combinations, out of the millions possible, could most effectively treat their cancer. It then provides oncologists with clear, accessible, predictive treatment analysis in an easy-to-read report that equips them with actionable knowledge tailored for each unique case. With xCures, cancer patients get immediate access to their care summary and all of their medical data in one easy-to-access place, greatly facilitating the finding of promising treatment options, even as they seek second opinions and try new therapies.

The collaboration between CureMatch and xCures will give oncologists clear, comprehensive access to patient records and past treatments, enabling them to make more informed recommendations for combination precision cancer treatments based on the CureMatch report.

“The collaboration between xCures and CureMatch brings together two leading companies at the forefront of digital healthcare innovation,” said Mika Newton, CEO of xCures. “By combining our strengths, we are confident that we can accelerate the adoption of precision oncology and improve outcomes for cancer patients globally.”

“This partnership represents a significant step forward in harnessing the power of AI technology to optimize cancer care,” said Navid Alipour, CEO of CureMatch. “By combining xCures’ patient medical history platform and our treatment-matching algorithm, we can make the process of obtaining genetically tailored, precision cancer therapies a reality for more patients.”

About CureMatch®

CureMatch is a leader in precision medicine digital solutions. Created on the belief that oncologists everywhere should benefit from world-class research, the CureMatch Decision Support System helps guide oncologists in the selection of cancer drugs that are customized for individual patients based on the molecular profile of their tumor, allowing each oncologist to become an expert in personalized medicine for better patient outcomes. www.CureMatch.com

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time.

The platform’s portals, xINFORM for patients and xDECIDE for providers, provide scientific and medical rationales for all treatment options.

The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials.

For more information, contact info@xcures.com or visit our homepage.

xCures showcases the power of its real-time clinical data platform at ASCO Annual Meeting 2023

Real-world patient data gives valuable insights, such as collecting data on rare cancers and showing real-world side effects of treatment combinations. 

[Oakland, CA, May 26, 2023] – xCures, a healthcare technology company, is pleased to announce its participation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023, to be held from June 02 – 06, 2023, at McCormick Place, Chicago, IL USA.  

The two abstracts accepted showcase the capabilities of its real-time clinical data platform to support patient care. The abstracts illustrate the platform´s enhanced longitudinal nationwide data beyond existing traditional retrospective real-world data (RWD) and how its platform can prospectively track clinical outcomes for (rare) cancer patient populations and structure clinical data for decision support.

“Access to real-time, longitudinal, uninterrupted clinical data offers an unparalleled capacity to extract insights from patient medical records,” said Tim Stuhlmiller, Vice President of Scientific and Medical Affairs at xCures, “these abstracts showcase our ability to utilize real-world data to improve patient care today, rather than 2-5 years from now.”

The xCures data platform, powered by a connection to the health information exchange and structured FHIR and CCDA data direct from institutional EMRs, has enabled a nationwide analysis of glioblastoma therapeutic combinations.

Under the guidance of Dr. Michael Castro of the Beverly Hills Cancer Center, a potentially practice-changing detrimental effect of proton pump inhibitors in glioblastoma was unveiled. This data is critical since up to 60% of brain cancer patients are prescribed these drugs, which could easily be exchanged for drugs with a different mechanism of action.

In a second abstract, xCures supports Dr. Paul Kent and the FibroFighters advocacy group to implement a multidisciplinary, international tumor board for fibrolamellar carcinoma, a rare adolescent and young adult cancer.

This tumor board is one of the world´s few international virtual tumor boards and the first ever for fibrolamellar carcinoma, offering patients a free consultation from leading experts. The xCures outcomes database provides actionable clinical data to guide decision-making in the tumor board. In addition, the platform collects outcomes prospectively to close the learning loop and improve future recommendations of the board.

Attendees of the ASCO Annual Meeting are encouraged to find Tim Stuhlmiller, Mark Shapiro, and Max Goldstein from xCures, who can provide in-depth insights, discuss potential collaborations, and showcase case studies from the platform´s implementation.

The abstracts presented:

Use of proton pump inhibitors (PPI) in glioblastoma (GBM) and relationship to overall survival in a national real-world evidence (RWE) database.

Authors: Michael Castro, Jameson Quinn, Asher Wasserman, Mark Shapiro, Timothy Stuhlmiller, Santosh Kesari

https://meetings.asco.org/abstracts-presentations/223217

and,

Clinical utility of an international multidisciplinary virtual tumor board for fibrolamellar carcinoma.

Authors: Paul Kent, Jordan Tasse, Erik Schadde, Tomoaki Kato, Abhinav Humar, Oliver Fisher, Matthew Dixon, Darrell Yamashiro, Albert Cornelius, Nelson Royall, Thomas Kim, Julie Friedland, Timothy Stuhlmiller, Alaa Awawda, Alanis Sabates, Mark Shapiro, Jessica Ellison, Tom Stockwell

https://meetings.asco.org/abstracts-presentations/224077

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from all sites of care. The (unstructured) data is aggregated and organized into a powerful, always up-to-date care summary that helps cancer patients get the right therapy at the right time.

The platform´s portals, xINFORM for patients and xDECIDE for providers, provide scientific and medical rationales for all treatment options. The research portal, xUTILITY, generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials.

For more information, contact info@xcures.com or visit http://www.xcures.com.

Genome Medical and xCures Partner to Enhance Genetic Services with Personalized Clinical Data

Genome Medical and xCures have joined forces to provide patients with a new level of personalized care. Through this collaboration, Genome Medical’s genetic counselors will have access to xCures’ comprehensive care summaries for patients based on electronic medical records from across the healthcare ecosystem. This information will be used to better inform the treatment of Genome Medical patients.

Genome Medical’s national reach and industry-leading genetic counseling services deliver critical insights and care to patients as they understand the risk factors and genetic implications of their conditions.

“Together, we are delivering the knowledge and data that is vital for precision medicine,” said Mika Newton, CEO of xCures. “Our real-time clinical data offers unique insights for patients and providers in their fight against cancer.”

“We look forward to collaborating with xCures to deliver an enhanced level of care to our patients and with an even more complete view of the patient’s health background,” said Jill Davies, CEO of Genome Medical. “This collaboration will have a great impact on the patients we serve, with the potential for an even greater impact on population health through enhanced research for oncology and other inherited diseases.”

Incorporating xCures’ real-world clinical data into the comprehensive Genome Medical genetic counseling sessions is another example of both companies’ mission to help integrate powerful genetic insights into a patient’s health journey.  It brings to life the promise of genomic medicine, making genetic information clinically actionable for patients and their providers while supporting providers in their efforts to deliver genetic services at-scale.

The companies will also collaborate with researchers to use the aggregated knowledge gathered from this initiative to further research and treatment that has the potential to improve care and outcomes across care settings. With this exciting new collaboration, Genome Medical and xCures are revolutionizing patient care and shaping the future of connected health.

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from any institution a cancer patient visited and organizes them into a powerful care summary. This summary facilitates the generation of treatment options reports and connects cancer patients and their physicians with optimal approved or investigational therapies. The platform prospectively generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com or visit http://www.xcures.com.

About Genome Medical

Genome Medical, the leading telegenetics care delivery company, is making genetic care accessible and actionable for patients through seven-day a week access to genetic services. By partnering with health systems, providers, labs and biopharmaceutical companies, Genome Medical expands the reach and impact of genomic medicine. The company helps its partners deliver clinical risk assessments for patients, genetic test recommendations and ordering, pre and post-test genetic counseling through its team of expert genetic counselors and personalized care plans. Headquartered in South San Francisco, Genome Medical has been honored as “The Best Digital Health Company to Work For” by Rock Health and the “Top 50 in Digital Health” by Fenwick & West and Goldman Sachs. To learn more, visit genomemedical.com and follow @GenomeMed.

xCures partners with RenovoRx to assist patients in accessing RenovoRx’s TIGeR-PaC study

RenovoRx’s Phase III clinical study is open to pancreatic adenocarcinoma patients and focuses on extending overall survival and improving quality of life.

[EINPresswire] xCures, Inc. is proud to announce their partnership with RenovoRx, a clinical-stage biopharmaceutical company that focuses on fighting cancer through localized treatment of difficult-to-treat tumors, such as pancreatic adenocarcinoma. Through this collaboration, xCures will help eligible pancreatic cancer patients access a Phase III clinical study entitled, Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer (TIGeR-PaC).

The primary focus of the TIGeR-PaC study is to administer targeted therapy to pancreatic cancer patients safely and without transmission to non-targeted areas. The end goals are to determine whether this targeted method of delivering chemotherapy can extend survival while also improving quality of life.

Although pancreatic cancer treatment has improved, pancreatic cancer patients continue to have poor outcomes – partially due to the tissue surrounding the tumor hampering intravenously delivered chemotherapy drug access to the cancer cells. Unlike intravenous (systemic) chemotherapy, RenovoRx’s technology delivers chemotherapy directly to the pancreas via an artery close to the tumor. RenovoRx designed this technology based on evidence that administering chemotherapy in this way may shrink or stabilize certain types of cancer. In fact, studies have demonstrated that gemcitabine (an FDA-approved chemotherapy) administered directly via the pancreatic arteries may be associated with more than half the patients living over two years.

“As the RenovoRx team looks forward to reporting the first prospective interim analysis for the TIGeR-PaC study, expected in the beginning of 2023, we are pleased to partner with xCures to aid additional pancreatic cancer patients gain access to our study,” said Shaun Bagai, CEO of RenovoRx. “Our therapy platform is challenging the standard-of-care treatment (systemic chemotherapy) available to locally advanced pancreatic cancer (LAPC) that is often associated with debilitating side effects for patients.”

Mr. Bagai added, “Results of Phase I/II and observational registry studies suggest that the RenovoRx therapy platform may enhance patient survival while countering chemotherapy tolerability issues. The result could be more time for patients with their loved ones and improved quality of life.”

“We are thrilled to partner with RenovoRx and help more pancreatic cancer patients gain access to the TIGeR-PaC clinical study,” said Mika Newton, CEO of xCures. “We hope our combined efforts will improve recently diagnosed pancreatic cancer patient’s health and quality of life outcomes.”

The TIGeR-PaC study is open to adults recently diagnosed with pancreatic adenocarcinoma that has not spread to other body parts and cannot be treated surgically. If you are interested in signing up for the study, click here. Once you do so, a member of the xCures study team will assist you through the screening and enrollment process if you are eligible.

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from any institution a cancer patient visited and organizes them into a powerful care summary. This summary greatly facilitates the generation of treatment options reports and connects cancer patients and their physicians with optimal approved or investigational therapies. The platform’s portals, xINFORM for patients and xDECIDE for providers, provide scientific and medical rationales for all treatment options. The platform prospectively generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com.

About RenovoRx

RenovoRx is a clinical-stage biopharmaceutical company with a vision to disrupt the current paradigm of cancer treatment. The company’s mission is to lead a revolution in oncology therapy by delivering its innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors. The proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP®)  therapy platform aims to avoid the harsh side effects typical of the current standard of care, thus improving patient well-being and extension of life so more time may be enjoyed with loved ones. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx’s lead product candidate, RenovoGemTM, is a combination of gemcitabine and our patented delivery system, RenovoCath®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase III TIGeR-PaC trial for the treatment of LAPC.

RenovoRx’s patent portfolio for its therapy platform and product candidates includes seven U.S. patents, one European patent and several additional patents pending in the US, EU and Asia. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

Learn more by visiting the RenovoRx website or following us on FacebookLinkedIn and Twitter.

xCures Joins Big Names in Aetion’s New Initiative

xCures, a Real-Time Regulatory Grade Clinical Data (RRC) platform, will be joining Aetion, a global real-world evidence software and analytics provider, and a group of leading diverse partners in Aetion’s launch of the Coalition for the Advancement of RWE through Randomized Controlled Trial Emulation (CARE) Initiative.

Aetion’s initiative will focus on better understanding the regulatory questions that can be answered using RWE and randomized controlled trials (RCTs), and when and why RWE and RCTs might yield the same or different results. It will conduct multiple trial emulations in various data sources, beginning with a one-year focus on oncology. Using the Aetion Evidence Platform, the Initiative will help identify when and how RWE can support the goals of advancing efficient access to medication and improving patient care.

“xCures has implemented real-time access to retrospective and prospective medical data, including the knowledge captured in unstructured notes and images, through a regulatory grade platform,” said Mika Newton, CEO of xCures. “This transforms the nature and scope of our understanding of patient outcomes and is critical to rapidly advancing research and care.” 

Other partners joining xCures in building this relationship with Aetion include AbbVie, Amgen, AstraZeneca, Bayer, Baylor College of Medicine, Brigham and Women’s Hospital and Harvard Medical School, ConcertAI, Duke-Margolis Center for Health Policy, Friends of Cancer Research, Gilead, Loopback Analytics, Pfizer, Reagan-Udall Foundation, Tempus, TriNetX,

For additional information, visit https://aetion.com/resources/care-initiative/

About Aetion

Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare’s most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at aetion.com and follow us at @aetioninc.

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from any institution a cancer patient visited and organizes them into a powerful care summary. This summary greatly facilitates the generation of treatment options reports and connects cancer patients and their physicians with optimal approved or investigational therapies. The platform’s portals, xINFORM for patients and xDECIDE for providers, provide scientific and medical rationales for all treatment options. The platform prospectively generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com.

xCures presents clinical and translational research with two posters at the 2022 SNO Annual Meeting

XCELSIOR registry showcases its power in using real-world datasets and clinical outcomes to aid decision-making and treatment options for CNS cancer patients.

[EIN Presswire] Today, xCures announced that they will present two posters at the 27th Annual Meeting of the Society for Neuro-Oncology, from the 16th to the 20th of November 2022, in Tampa Bay, Florida.

The Society for Neuro-Oncology is a multidisciplinary society of healthcare professionals dedicated to promoting advances in neuro-oncology through research and education. Their annual meeting features research and educational sessions on brain tumors, including the latest on diagnosis and treatments.

The two xCures posters will be presented at the Poster Session on Friday, November 18, 2022, from 7:30 pm-9:30 pm EST, and are entitled:

EPCO-10: Systems biology-based therapeutic predictions with gbmSYGNAL and clinical correlates in the real-world longitudinal outcomes registry XCELSIOR

Timothy J. Stuhlmiller, Serdar Turkarslan, Julie C. Friedland, Asher Wasserman, Jameson Quinn, Zac Cole, Alaa Awawda, Sabrina Irizarry, Sebastian Williams, Mark Shapiro, Santosh Kesari, Anoop P. Patel, Nitin S. Baliga

BIOS-03: Real world clinical outcomes of patients with diffuse midline glioma in a longitudinal outcomes registry

Timothy J. Stuhlmiller, Asher Wasserman, Jameson Quinn, Zac Cole, Alaa Awawda, Sabrina Irizarry, Sebastian Williams, Mark Shapiro, Al Musella, Santosh Kesari

“I’m proud to present these analyses of real-world data and clinical outcomes of CNS cancer patients from our observational registry,” stated xCures’ VP of Scientific and Medical Affairs Timothy J. Stuhlmiller. “Together with leading neuro-oncologists and computational biologists, we are bringing evidence-based insights to the treatment of brain cancer patients.”

The xCures platform generates Real-time, Regulatory-grade, Clinical data (RRC). It now includes data on over 1,000 brain cancer patients, permitting real-time insight into which treatments show the most promise across patient cohorts.

Emerging data on investigational and off-label interventions will be presented for patients with diffuse midline glioma (DMG), along with data from a partnership with the Institute of Systems Biology (ISB) integrating real-world clinical outcomes with a systems biology algorithm for treatment predictions to identify rational treatment options for glioblastoma patients.

Posters will be available for viewing digitally at https://xcures.com/publications/ on Friday, November 18, 2022, at 7:30 pm EST.

About xCures

xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from any institution a cancer patient visited and organizes them into a powerful care summary. This summary greatly facilitates the generation of treatment options reports and connects cancer patients and their physicians with optimal approved or investigational therapies. The platform’s portals, xINFORM for patients and xDECIDE for providers, provide scientific and medical rationales for all treatment options. The platform prospectively generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. For more information, contact info@xcures.com

Finally, cancer patients have real-time access to their medical records

Recent changes to patients’ data rights enable xCures’ platform to automatically retrieve patient medical records from institutions and generate powerful care summaries.

EINPressWire, 11/8/22

Last month, the 21st Century Cures Act forced healthcare organizations to provide patients quick and easy access to their health records in a digital format.

In response to the news, xCures is happy to announce that patients using their platform, can now automatically retrieve their medical records from the institutions where they received care, and get instant access to a powerful care summary. For free.

“The xINFORM Care Summary is extremely useful for patients and physicians. The power lies in the underlying structuring of data” said Mika Newton, CEO of xCures. “Cancer is personal, and our A.I.-powered platform uses the systematically structured data to improve the quality of healthcare encounters, identify eligible patients to participate in research and care programs, and prioritize personalized treatment options.”

Founded in 2018, xCures currently stands at the forefront of innovation in how healthcare technology can benefit both patients with cancer and medical professionals in the field of oncology.

Their xINFORM portal automatically requests all medical records on a patient’s behalf and is integrated with national Electronic Health Information Exchange (HIE) networks. If data is still missing, xCures can query individual providers outside the network to receive complete records. Going far beyond the structured data, the xCures A.I.-powered platform abstracts knowledge from unstructured data such as physician notes and embedded images such as genomics reports.

This means all data, regardless of where it came from, is uniformly structured, in one place, for the convenience of the patient.

In near real-time, a “Care Summary” is generated. Patients can share this up-to-date and accurate information with their medical providers and professionals, making it easy for them to review a patient’s cancer journey and facilitate access to promising trials or alternative treatments. The complete medical records are simultaneously available for use, enabling all participants to have the source data as needed.

xCures’ A.I. matching engine can actively cross-reference a vast library of oncology data to match each patient with the most promising treatment options. Options can be novel or off-label, based on insights from leading experts and predicted outcomes.

Together, these services empower patients and their oncologists to make the most informed and effective treatment decisions throughout their cancer journey.

About xCures:
xCures Inc. operates an AI-assisted platform that automatically retrieves medical records from any institution a cancer patient visited and organizes them into a powerful care summary. This summary greatly facilitates the generation of treatment options reports and connects cancer patients and their physicians with optimal approved or investigational therapies. The platform’s portals, xINFORM for patients and xDECIDE for providers, provide scientific and medical rationales for any treatment options. The platform prospectively generates Real-time Regulatory-grade Clinical (RRC) Data for studies and decentralized trials. For more information, contact info@xcures.com.

xCures and mProbe partner to help cancer patients determine optimal treatments

xCures partners with mProbe, to leverage their targeted proteomics platform for profiling individual patients’ cancer tissues for actionable drug targets

xCures, Inc. is proud to announce their collaboration with mProbe Inc., a premier CLIA-certified targeted proteomics company. mProbe utilizes a proprietary technology platform integrating artificial intelligence and multi-omic diagnostics to transform the diagnosis, prevention, and treatment of complex diseases such as cancer.

As the knowledge of cancer and its treatments advance, it is ever more apparent that every cancer is unique. Through this collaborative partnership, xCures and mProbe will work toward helping cancer patients better understand their tumors’ molecular profile at the proteomic level, allowing precision diagnostics to guide precision medicines by selecting the most effective cancer treatment regimens. mProbe uses a pathologist guided laser microdissection platform to isolate tumor areas from formalin fixed paraffin embedded (FFPE) tissue followed by multiplex mass spectrometry-based quantification of targets for chemotherapy, targeted therapy and immunotherapy.  The clinical proteomics test is marketed as OncoOmicsDx.

By integrating xCures’ rich real-world longitudinal clinical data with mProbe’s cancer proteomics panels, the two companies are working to expedite the discovery of predictive, diagnostic, and prognostic biomarkers for cancer.

“We are thrilled to partner with mProbe and to leverage their OncoOmicsDx platform for profiling cancer tissues for patients on our platform,” said Mika Newton, CEO of xCures. “We hope our combined efforts towards identifying and expanding upon precision-based actionable drug targets will help cancer patients find the best treatments for their unique cancers.”

“When mProbe and xCures join forces in the fight against advanced cancer by offering integrated treatment plans which leverage targeted proteomics, precision diagnostics,  artificial intelligence, and predictive modeling, we are giving hope to advanced cancer patients who have exhausted the standard of care.” said Peter Chen, CEO of mProbe.  “With this new collaboration, we will be able to provide oncologists with actionable proteomic information to help them make informed decisions,” said Dr. Sheeno Thyparambil, Ph.D.,  Senior Director of R&D at mProbe. 

About xCures

xCures Inc. operates an AI-assisted platform that helps cancer patient aggregate, organize, and structure all their medical data into an easy-to-use Care Summary. The Care Summary greatly facilitates the generation of a Treatment Options Report, and connects cancer patients and their physicians, with optimal investigational or approved therapies.

The platform’s portals, xINFORM for patients, and xDECIDE for providers, show scientific and medical rationales for any treatment options provided. The platform prospectively generates Real-time Regulatory-grade Clinical Data for studies and decentralized trials. For more information, contact info@xcures.com.

About mProbe

mProbe Inc.is a leading biotechnology company based in Palo Alto, California is committed to promoting human health in the fields of precision diagnostics and healthcare analytics.  mProbe has developed a proprietary technology platform integrating artificial intelligence and multi-omic approach to transform the disease diagnosis, prevention, and treatment paradigm. For more information, please visit www.mprobe.com.

xCures and Oblato announce the launch of a Compassionate Use program for OKN-007

Oblato’s first-in-class small molecular OKN-007 will be available through a newly opened compassionate use protocol.

xCures, Inc., a clinical study platform provider, and Oblato, Inc., a biotechnology company, are pleased to announce the availability of OKN-007 through an intermediate size expanded access program (iEAP) for eligible patients with pediatric diffuse midline glioma (DMG), inclusive of diffuse intrinsic pontine glioma (DIPG). Oblato is currently developing OKN-007 as a treatment for glioblastoma multiforme (GBM).

Pediatric diffuse gliomas are rare but have a very poor prognosis, and current treatment options show little benefit. Because pre-clinical research and emerging clinical data support the potential for OKN-007 in this population and the life-threatening nature of malignant gliomas including DIPG, Oblato is making OKN-007 available to qualified physicians through the iEAP.

“xCures is pleased to continue our efforts to bring pre-approval access to investigational medications for pediatric cancer patients. We are excited about the underlying science behind OKN-007 and the opportunity to use our platform to generate evidence and accelerate OKN-007 development. Our platform offers an efficient solution for physicians and patients seeking access to promising therapies when clinical trials are not an option,” says Mika Newton, CEO of xCures. “xCures’ has a track record of delivering high-value real-world evidence from expanded access programs.”

Ki -Hong Ahn, CEO of Oblato comments, “We are pleased that xCures will serve as the partner for the iEAP. With the new protocol now in place, we look forward to initiating this important program for pediatric cancer patients. We will expand the investigation into OKN-007 for DMG and DIPG patients as well as GBM patients.”

This treatment protocol (NCT05518838) is now available. Interested patients or physicians can learn more at xcures.com/details/okn007/.

About Expanded Access:
Expanded access, which is often called “compassionate use,” is the use of an unapproved drug for treatment of patients with serious or life-threatening illnesses outside of a clinical trial. Expanded access is subject to oversight from the US FDA in accordance with the regulations outlined in 21 CFR 312.305.

About Oblato:
Oblato, Inc., a wholly-owned subsidiary of the Korean biotech company HLB Therapeutics, is incorporated in Delaware and has its principal place of business in New Jersey. Since 2016, the Company has been developing a new drug, OKN-007, to treat brain cancers, especially, GBM as a rare disease and DIPG as a rare pediatric disease. Currently, clinical trials are ongoing to investigate the safety and efficacy of a combination therapy with both OKN-007 and temozolomide for patients with both newly diagnosed and recurrent GBM. Oblato has received both rare pediatric disease and fast track designations for DIPG. For additional information about Oblato, please visit www.oblatoinc.com.

About xCures:
xCures Inc. provides clinical study platforms that use AI/ML algorithms to support tumor boards with the allocation of cancer patients to optimal treatment programs and clinical trials. The xCures platform prospectively generates Real World Evidence for investigational and approved therapies. Patient EMR data is continuously collected, stored, and structured into a regulatory-grade format that is ready for use in submissions to the FDA. For more information, contact info@xcures.com.

This was first released on EINPresswire

Pancreatic Cancer Patients Will Now Have Remote Access to Precision Nutrition Trial Through New Partnership

xCures and Vault Health integration creates a decentralized platform to benefit pancreatic cancer research and facilitate enrollment in Faeth’s NEAAR-001 study

xCures, Inc. is proud to partner with Vault Health, a decentralized research and workforce screening company, to facilitate the enrollment of pancreatic cancer patients in Faeth Therapeutics’ NEAAR-001 research study. NEAAR-001 is a clinical trial of a precision nutrition-based diet that restricts specific amino acids that preclinical studies suggest are necessary for cancer growth. The study involves patients with recently diagnosed metastatic pancreatic adenocarcinoma who are scheduled to receive chemotherapy treatment with gemcitabine and abraxane.

Vault Health’s decentralized research capabilities will allow Faeth to extend the NEAAR clinical trial beyond physical clinical trial sites to patients living across the country. By combining xCures’ records collection, virtual screening, eConsent and data structuring technology with Vault Health’s state-of-the-art suite of patient-centric clinical research services, including telemedicine, remote sample collection, and logistics, the NEAAR-001 protocol can be delivered directly to patients in the convenience of their homes.

“We are thrilled to partner with Vault Health and Faeth Therapeutics to help recently diagnosed pancreatic cancer patients access the NEAAR-001 study as a patient-centric and decentralized clinical trial,” said Mika Newton, CEO of xCures. “Importantly, our combined efforts will enable cancer patients from diverse populations and socioeconomic backgrounds to participate in research.”

“We are excited to bring our patient-first philosophy to simplify the journey and offer clinical research as a care option to pancreatic cancer patients,” said Alexander Pastuszak, MD, PhD, President of Clinical Care and Chief Medical & Scientific Officer, Vault Health. “Together with xCures and Faeth Therapeutics, we are looking forward to rapidly recruiting and enrolling patients where they are, reducing recruitment timelines and costs, and increasing patient engagement.”

“Faeth is dedicated to curing every cancer for every patient, and this partnership with Vault Health and xCures will make it easier for many more people with metastatic pancreatic cancer to access our precision nutrition intervention,” said Faeth co-founder and CEO Anand Parikh. “Faeth would like to offer access to our clinical trials to a wider subset of patients, and by enabling remote access to the NEAAR-001 study, they can enroll in our trial without having to leave home, regardless of where they’re based.”

This was first published on EINPresswire

About xCures
xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform’s portals, xINFORM for patients, and xDECIDE for providers, show scientific and medical rationales for the options provided and a clear picture of a patient’s medical records and history. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, contact info@xcures.com.

About Vault
Vault is at the forefront of simplifying the execution of decentralized and hybrid clinical trials and providing the highest quality patient experience, supported by state-of-the-art technology and virtual care. Vault’s mission is to accelerate better health outcomes through faster diagnosis, innovative clinical research and digital-first care delivery. Vault works with more than 3,000 world-class customers – including corporate, public health, education, pharma and biotech – to deliver care to their populations. Learn more: https://www.vaulthealth.com/

About Faeth
Faeth Therapeutics is a cancer metabolism company developing clinically-tested nutrition control, therapeutics, and digital tools for the treatment of cancer. Founded in 2019 by leading researchers in Europe and the United States and backed by leading investors, the company is pioneering its work in cancer metabolism to support a radically new way to treat cancer. Faeth’s research, published in peer-reviewed scientific journals, shows that tailoring the right diet to the cancer patient can significantly impact the efficacy of clinically tested therapeutics for cancer. Feed the fight. For further information: www.faeththerapeutics.com

xCures partners with Travera to support advanced carcinoma patients and their physicians 

Decentralized clinical trial for patients with advanced carcinomas helps determine their cancer’s response to specific drugs

[EIN Presswire, July 19, 2022] xCures, Inc. is proud to announce their partnership with Travera, and the launch of a decentralized clinical trial that provides patients with advanced carcinoma a functional profile of their cancer cells. Advanced carcinoma patients often have malignant fluid drained to provide symptomatic relief. Travera’s unique technology takes advantage of this fluid to screen the response of the live tumor cells against approved anti-cancer therapies. 

“We are excited to partner with Travera and leverage the application and clinical utility of their incredible technology,” said Mika Newton, CEO of xCures. “This study will provide many important outcomes, giving patients and their physicians insight into the cancer’s response to various drugs from a screening panel, eventually helping clinical and treatment decision-making.”

The study (TraveraRTGx) will run as a hybrid decentralized research trial utilizing a CLIA-approved test, meaning that the results will be communicated to the physicians and their patients. It will be open to anyone with carcinoma and malignant fluid (pleural effusion, ascites, etc.), most commonly patients with breast cancer, lung cancer, or abdominal cancers. When patients enroll in the study, xCures will work with treating physicians and institutions to ensure the excess fluid is properly stored and sent to Travera, where cancer cells in the fluid will be screened against candidate drugs relevant to the specific patient or cancer type. 

“We are thrilled to partner with xCures and expand the clinical applications of our unique screening technology based on cancer cells’ growth response to candidate drugs,” states Clifford Reid, Travera’s CEO.” Tumor cells in this often discarded malignant fluid can provide critical information about which drugs to prescribe.”

Advanced carcinoma patients and their caregivers interested in the study can register and learn more at https://xcures.com/details/advanced-carcinoma/

About Travera

Travera assists oncologists in selecting treatments for their patients with our revolutionary cancer therapy guidance test that predicts which cancer drugs are most likely to be effective for each cancer patient.  Using a disruptive single-cell measurement technology invented at MIT that measures the ex vivo growth response of live tumor cells to candidate drugs, Travera has overcome the problems that have prevented the many previous generations of therapy guidance tests from being effective in clinical practice. Travera’s 2-day Rapid Therapy Guidance™ test enables patients who are running out of therapeutic options to discover additional options and continue their battle against cancer.  

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform’s portals, xINFORM for patients, and xDECIDE for providers, show scientific and medical rationales for the options provided and a clear picture of a patient’s medical records and history. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, contact info@xcures.com or visit www.xcures.com.

xCures and Novocure® partner to better understand quality of life in glioblastoma

Innovative collaboration focused on developing the first comprehensive Quality of Life dataset for glioblastoma patients

[EIN PressWire June 21, 2022] xCures, Inc., is proud to announce their partnership with Novocure with the intent to develop the first comprehensive, longitudinal Quality of Life (QoL) dataset for glioblastoma (GBM) patients. The alliance between both oncology companies will leverage xCures’ novel, patient-centric platform and deep connections to GBM patient and provider communities through direct engagement with GBM patients, unique partnerships with advocacy groups such as the Musella Foundation, and the offering of valuable services such as cancer history structuring and treatment options research.

“We are delighted to team up with Novocure and see our extensive real-world data from GBM patients applied towards developing a time series analysis of QOL in GBM,” said Mika Newton, CEO of xCures. “As a patient-centric company, we look forward to the outputs of this partnership and to seeing how they improve Quality of Life for those with this devastating cancer.”

Participants enrolled in xINFORM are invited weekly to complete the EuroQol 5-Dimension (EQ-5D-5L) QoL survey. The survey results provided by patients will allow for time series analysis of QoL in GBM. Over the coming year, Novocure and xCures will generate QoL data for 250 patients and integrate it with regulatory-compliant longitudinal outcomes data.

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform’s portals, xINFORM for patients, and xDECIDE for providers, show scientific and medical rationales for the options provided and a clear picture of a patient’s medical records and history. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, contact info@xcures.com.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and in the U.S. for the treatment of adult patients with malignant pleural mesothelioma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Jersey, and with a growing global footprint, Novocure has regional operating centers in Root, Switzerland, Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter. Novocure is a registered trademark of Novocure GmbH.

Prognos Health and xCures Partner to enable Access to Real World Oncology Datasets

The new collaboration focuses on improving outcomes by continuous learning from every patient’s journey across diverse datasets

CHICAGO, IL, UNITED STATES, June 3, 2022 /EINPresswire

Today, at the annual meeting of the American Society of Clinical Oncology (ASCO), Prognos Health and xCures announced a collaboration to enable real-world data access and insights for life science companies across multiple use cases.  The multi-year agreement will enable linking and access to xCures de-identified data and Prognos healthcare data marketplace.

“We are excited about combining our respective capabilities to improve outcomes and drive powerful insights on gaps in care, therapy impact, and real-world patient outcomes in oncology,” said Mika Newton, CEO of xCures. “We are focused on finding the right treatment for cancer patients and together we believe we can help accelerate that goal.”

“Collaborating with xCures is a great example of how Prognos is solving for disconnected, siloed data that cannot interoperate and leaves an incomplete view of the patient, said Sundeep Bhan, founder and CEO of Prognos. “Providing the ability to combine patients’ data across all data types including lab, claims, pharmacy, EHR, mortality, and SDoH data is critical to improving patient outcomes in Oncology.”

Prognos and xCures utilize Datavant’s Encrypted Token Technology, which enables HIPAA-compliant linking of de-identified patient records to exchange data seamlessly and securely throughout the Datavant ecosystem of partners.

About Prognos Health

Prognos Health is the leading clinically focused data and analytics platform company. The Prognos Factor® platform has the power to query billions of fully integrated lab and health records on more than 325 million de-identified patients to answer or uncover key healthcare questions in minutes, not months. Leveraging the company’s patent-pending technology Prognos enables the agile exchange of integrated, patient-centric data between key healthcare stakeholders directly from the Prognos Marketplace.

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com or contact info@xcures.com.

xCures joins C-Path’s Cure Drug Repurposing Collaboratory to Deliver AI-enabled Data Abstraction of Health Records

Members of CDRC will be able to utilize xCures’ technology to quickly abstract and structure clinical data to support drug repurposing studies in rare cancer.

xCures today announced has joined the Critical Path Institute’s (C-Path) Cure Drug Repurposing Collaboratory (CDRC). CRDC is operated by C-Path as a public-private partnership with the U.S. Food and Drug Administration (FDA), and the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).

CDRC’s mission is to facilitate the advancement of drug repurposing, through the use of real-world outcomes data, especially for diseases of high unmet medical need and where there is little financial incentive to develop new drugs. This includes the systematic collection and assessment of the use of existing FDA approved drugs used to treat diseases and conditions that are not on the existing label.

CDRC members are now able to use xCures’ AI-powered software to enable abstraction and mapping of raw data from print or electronic health records (EHR) into a 21 CFR 11 compliant electronic database. xCures’ software platform enables clinical researchers in academic or industry settings to quickly process large volumes of unstructured medical records, and map those to an industry standard clinical data model that utilizes standard biomedical dictionaries and ontologies, while preserving links to source data. This solution substantially reduces the time required to collect and process clinical research data, including data from clinical trials and registries.

By joining the CDRC, xCures empowers consortium members to increase the speed and quality of abstracted clinical data to support exploratory and pivotal studies of repurposed drugs, particularly for rare cancers, including angiosarcoma, a rare cancer affecting the lining of blood vessels.

“By joining the CDRC, we are excited to deploy our EHR-to-EDC solution to catalyze the development of real-world data that can advance and support the identification of safe and effective treatments for rare cancers,” said Mark Shapiro, COO of xCures. “Empowering rare cancer researchers with high-quality, longitudinal clinical data will provide evidence supporting clinical and regulatory decision-making.”

CDRC members include partnerships with international rare cancer patients, researchers, government institutions, and regulators. “We are excited that xCures is joining CDRC,” said Marco Schito, Ph.D., CDRC Executive Director. “This partnership will enable CDRC members researching rare cancers to access state-of-the-art tools to facilitate clinical evidence generation using real-world data.”

The goal will be to develop infrastructure to identify existing generic drugs used to treat rare diseases, which can become candidates for drug repurposing efforts. Deidentified data, in the form of case reports, would be made available publicly.

Patients and physicians interested in the xCures platform may create new accounts via the following link: https://enroll.xcures.com.

For more information about CRDC visit, https://c-path.org/programs/cdrc/.

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with information about treatment options generated from ongoing collection and processing of health records. The platform prospectively generates regulatory grade real-world data for clinical studies and decentralized trials. For more information or to learn more about xCures’ technology, contact: info@xcures.com.

About C-Path
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. For more information, visit www.c-path.org.

Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government source(s), totaling $11,196,634. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.

Endeavor BioMedicines Partners with xCures to Identify Patients with PTCH1 mutations for Phase 2 Trial of ENV-101 (taladegib)

xCures to use tumor sequencing information and its platform to pair patients with available treatment options

Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, and xCures, a company that aims to improve cancer outcomes and accelerate cancer research using artificial intelligence, today announced a partnership that gives patients enrolling in Endeavor’s clinical trials access to the xCures platform to find the best available treatment options suited to their individual tumor profile. The partnership helps identify patients whose cancers harbor the PTCH1 mutation and may be eligible for Endeavor’s clinical trial. The xCures platform also enables patients to find more suitable treatment options if they are ineligible.

“Endeavor’s partnership with xCures aligns with our patient-first focus and will help guide any patients with cancer who contact us to find the best treatment options for them,” said Anita DiFrancesco, Vice President of Clinical Operations at Endeavor BioMedicines. “We recently dosed the first patient in a Phase 2 study evaluating ENV-101 (taladegib), a small molecule inhibitor of the Hedgehog signaling pathway, in patients with advanced solid tumors harboring PTCH1 loss of function mutations. Endeavor and xCures will work together to identify PTCH1 mutations while also providing alternative treatment options for patients who are ineligible for our trials.”

Patients will be registered on the xINFORM platform. Once a patient is registered, xCures will review their cancer history.  For patients without molecular profiling, xCures will assist patients with tumor sequencing. After the genomic information is added to a patient’s profile, they will receive a report that lists the best treatment options based on their cancer history and their genomic profile. If the patient has the PTCH1 mutation, they and their physician will be made aware of the option to enroll in the Endeavor clinical trial.  Patients whose tumors are negative for the PTCH1 mutation will receive a personalized list of treatment options that they should discuss with their oncologist.

“xCures is pleased to partner with Endeavor to help improve outcomes for cancer patients by helping them understand their treatment options and support them and their physician with access,” said Bryan Federowicz, Vice President of Clinical Operations at xCures. “This partnership is an example of how collaboration between industry, doctors and patients can provide the best, uniquely tailored medicine for each individual patient.”

ENV-101: Targeting the Hedgehog Signaling Pathway in Oncology and Fibrosis

ENV-101 (taladegib), an orally available small molecule inhibitor of the Hedgehog signaling pathway, has already demonstrated preliminary clinical efficacy and safety in nearly 200 subjects enrolled across six completed studies. Initially targeted for a broad group of patients with basal cell carcinoma (BCC), Endeavor is now investigating precision therapy approaches for ENV-101 in multiple types of cancers driven by oncogenic driver mutations in PTCH1, as well as in idiopathic pulmonary fibrosis (IPF).

PTCH1 oncogenic driver mutations in the Hedgehog signaling pathway are found in approximately 2% of all cancers. Because of its prevalence across multiple types of cancer, Endeavor plans to enroll patients in a tumor agnostic study that includes any patient with oncogenic hedgehog mutations irrespective of tissue of origin. Endeavor is currently enrolling patients in an open label Phase 2 clinical trial in oncology (www.clinicaltrials.gov identifier NCT05199584).

For more information about our clinical trial please contact us at: EBMClinical@endeavorbiomedicines.com or call us at 858-727-3199.

About xCures

xCures operates a precision oncology platform that includes direct-to-patient and direct-to-physician portals. The platform uses Artificial Intelligence/Machine Learning algorithms and Natural Language Processing to identify the most promising treatment options for advanced cancer patients.

The platform supports tumor boards and captures valuable data to help accelerate the development of promising new cancer drugs, expand the approved uses of existing drugs, and demonstrate value for reimbursement.

About Endeavor BioMedicines

Endeavor BioMedicines is a clinical-stage precision medicine company targeting the core drivers of multiple terminal diseases, including oncology and fibrosis. We combine advancements in technology with an evolving understanding of terminal diseases to develop best-in-class medicines with the potential to reverse the most severe health conditions. Our lead program, ENV-101, is a Hedgehog signaling inhibitor with demonstrated clinical activity that we are investigating in multiple cancers and in IPF. At Endeavor, we are a highly qualified, innovative and focused team that has come together to live up to our name and bold mission: to help patients feel better and live longer. Please visit us on our website at www.endeavorbiomedicines.com and on our LinkedIn and Twitter pages.

Media Contact
Ingrid Mezo, Account Director
ingrid.mezo@canalecomm.com
301-473-2881

xCures announces real world biomarker study for patients with FGFR-mutant bladder cancer receiving Balversa®

Tyra Biosciences supported study investigates if non-invasive blood and urine samples provide biomarkers to assess clinical response to erdafitinib treatment

Today, xCures announced their collaboration with Tyra Biosciences for a real-world biomarker study involving patients with FGFR-mutant bladder cancer receiving Balversa® (erdafitinib) as their standard of care medical therapy. The study is supported by Tyra Biosciences, Inc., a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. This study will investigate a patient’s tumor DNA through their blood and urine samples to provide information on their treatment and what options might be available if their disease worsens.

Bladder cancer is the sixth most common cancer in the United States and is associated with genetic mutations in the patient’s bladder or urothelium (the lining of the lower urinary tract). Approximately one in five patients with recurrent and refractory bladder cancer has alterations in fibroblast growth factor (FGFR) genes. These are typically detected with a tumor biopsy, a procedure that may be invasive and anxiety provoking.

US FDA has recently approved Balversa® to treat adult patients with locally advanced or metastatic urothelial carcinoma with certain FGFR2 or FGFR3 gene mutations. Overall, about one third of patients treated with Balversa® have a confirmed tumor response.  However, acquired resistance can be a consequence of treatment and is a devastating reality for patients initially responding to targeted cancer therapies. As new treatments have become more selective, there is a strong demand to address this significant limitation. 

In this study, samples collected from bladder cancer patients receiving standard of care Balversa® will be tested using a non-invasive diagnostic method that uses the blood and urine samples, instead of tissue, to detect gene alterations that may occur at the time of tumor progression. These less intrusive samples may allow for the assessment of how treatment with Balversa® affects clinical response, disease progression, and/or genetic alterations detected in cell free tumor DNA. 

“xCures is excited to partner with Tyra Biosciences to deliver on the promise of precision oncology and translational medicine for bladder cancer,” said Mika Newton, CEO of xCures.  “This study is a great example of how patients and their doctors have the opportunity to both better understand their options and contribute to research in real time.”

“We’re excited to support xCures on this biomarker study, which utilizes a non-invasive approach to identify FGFR mutations in patients with bladder cancer,” said Todd Harris, CEO of Tyra Biosciences.  “This study could yield valuable insights into FGFR-mutant biology and overall tumor progression in bladder cancer, and we hope to leverage these findings as we advance our TYRA-300 program toward the clinic.” 

The study is being conducted under a decentralized model, leveraging xCures’ direct-to-patient precision oncology platform to reach patients anywhere in the United States. Patients interested in participating in the study can get more information at:

https://xcures.com/details/balversa-monitoring/ and https://www.clinicaltrials.gov/ct2/show/NCT05052372

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, contact info@xcures.com.

About Tyra Biosciences 

Tyra Biosciences, Inc. is a precision oncology company focused on developing purpose-built therapies to overcome tumor resistance and improve outcomes for patients with cancer. TYRA’s proprietary in-house discovery platform, SNÅP, enables the rapid and precise refinement of structural design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies.  Leveraging SNÅP, TYRA is developing a pipeline of selective inhibitors of the Fibroblast Growth Factor Receptor (FGFR) family members, which are altered in approximately 7% of all cancers including TYRA’s lead product candidate TYRA-300, an FGFR3 inhibitor and TYRA-200, an FGFR2 inhibitor, as well as programs targeting achondroplasia and other FGFR3-related skeletal dysplasias, rearranged during Transfection kinase (RET) and FGFR4-related cancers. TYRA is based in Carlsbad, CA.  For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn

xCures and BioSpark partner to boost Real World Oncology Data offerings

New partnership allows for a 40,000+ patient dataset to unlock new insights into cancer treatments and outcomes.

xCures, Inc. and BioSpark, Inc. are proud to announce their strategic partnership to harmonize and commercialize a joint oncology Real World Data (RWD) offering. The partnership unlocks new insights into the treatment and outcomes of cancer patients through a novel dataset spanning 40,000+ cancer patients. The data results from the combined structuring of published case reports and comprehensive, cross-provider, Electronic Health Reports (EHRs) collected through XCELSIOR (NCT03793088).

RWD is necessary to provide direct insight and clinical decision support to patients and their treating oncologists through the xCures platform. The RWD is also available to support clinical research and development, health economics and outcomes research, and the generation of strategic insights across the life sciences and healthcare continuum.

“Our partnership with BioSpark rapidly expands the scope of the RWD that xCures is using to deliver on our promise to help patients and their physicians understand the best treatment options,” said Mika Newton, CEO of xCures. “Together, xCures and BioSpark are driving a fundamental shift in the quality, utility, and value of real-world evidence. The research and commercial insights from this data will be unparalleled.”

The RWD data set contains a diverse set of patient records, including:

  • 15,000+ breast cancer cases
  • 10,000+ colorectal cancer cases
  • 7,500+ pancreatic cancer cases
  • 5,500+ bladder cancer cases
  • 5,000+ lung cancer cases

All the data will be harmonized into Case Report Form (CRF) structure and allow for complete data source verification. The final data is in a CFR Part11 compliant database suitable for research and regulatory submissions. Highly useful for precision medicine, these data are particularly rich in genetic markers and biomarkers and offer complete longitudinal research-grade oncology outcomes, such as formal criteria-based tumor response or progression-free survival.

Mark Shapiro, COO of xCures, stated, ” The data BioSpark provides represents some of the most relevant and high-quality Real World Data available. Our companies share highly similar values and goals, and their data will provide a significant boost to our clinical decision support platform as well as our RWD offerings.”

“Our partnership with xCures is both unique and ideal. The XCELSIOR platform that xCures has developed is state-of-the-art and allows our data to be utilized in several important capacities that would not otherwise have been possible at this stage,” said Kristian Thorlund, Co-Founder and President of BioSpark.

External parties who wish to access the joint offering should contact info@xcures.com

About BioSpark

BioSpark is a rapidly growing start-up on a mission to turn the RWD industry upside down by dramatically accelerating the speed of delivery of high-quality research-grade RWD. Powered by proprietary technologies to streamline and minimize the need for manual curation, BioSpark is able to deliver high-quality complete longitudinal oncology data at unparalleled speeds. For more information, visit www.biospark.ai

About xCures

xCures operates a precision oncology platform that includes direct-to-patient and direct-to-physician portals. The platform uses Artificial Intelligence/Machine Learning algorithms and Natural Language Processing to identify the most promising treatment options for advanced cancer patients. 

The platform supports tumor boards and captures valuable data to help accelerate the development of promising new cancer drugs, expand the approved uses of existing drugs, and demonstrate value for reimbursement.

TARGET: Cancer Podcast to be hosted by media personality Dr. Sanjay Juneja – TheOncDoc

Oncologist and cancer educator Dr. Sanjay Juneja will host xCures’ informative podcast on cancer and technology

February 17, 2022 – Oakland, CA. – xCures, a direct-to-patient, and direct-to-physician oncology platform, is proud to announce Sanjay Juneja, MD, as the host to their TARGET: Cancer podcast. Dr. Sanjay Juneja is a leading oncologist and cancer educator with a significant following on social media as ‘TheOncDoc’. By focusing on innovative approaches to deal with cancer, the podcast aims to be a helpful asset to patients who are looking for new solutions.

Cancer remains a greatly feared diagnosis, with more than one out of every three men and women being diagnosed with cancer during their lifetimes. However, current technological and medical advances allow cancer patients to live fruitful and active lives. To inform podcast listeners about the most recent cancer technology, Dr. Juneja will talk to leading experts in cancer treatment and discuss the latest solutions so that audiences worldwide can learn and understand.  

“I have been active and successful on TikTok and Instagram where I quickly realized people have a strong desire to learn more about cancer. I have often been asked to start a podcast and after speaking to Mika Newton and learning more about xCures, I felt I needed to do this,” said Dr. Juneja. “I have always believed in the importance of educating people about cancer, and this podcast is a great way of doing it.”

With over 500,000+ followers on social media, Dr. Juneja is known as ‘TheOncDoc’ across social media platforms, including Instagram, TikTok, YouTube, and Facebook. He has been featured in The Washington Post, regional news channels (PBS, CBS, NBC, NPR), and on social media for MTV, PureWow, DailyMail, and Dr. Mike.

Dr. Juneja was initially scheduled to be a guest on xCures’ TARGET: Cancer Podcast. As a community oncologist, he felt that xCures provided a much-needed service to cancer patients in community practices across the country and was thrilled with the opportunity to host the podcast.

“Sanjay’s energy and desire to educate is inspiring,” said Mika Newton, CEO of xCures. “I am super excited that he is taking over as our host and can’t wait to see what he has in store.”

Previous TARGET: Cancer podcast episodes featured interviews with medical professionals and stories from other cancer patients. Future TARGET: Cancer podcasts will continue to be highly educational – it is the podcast where technology meets oncology. Now hosted by Dr. Juneja, the TARGET: Cancer podcast will have its own YouTube Channel and can be listened to on Spotify and Apple Podcasts.

About Sanjay

Dr. Sanjay Juneja is a triple board-certified Hematologist & Medical Oncologist serving as Chief of Oncology Service at Baton Rouge General Hospital. He is also a Founding Medical Partner of Doctorpedia.com where he serves as Chief Medical Officer of the Oncology Channel. 

Dr. Juneja is a published co-author in medical journals and has partnered nationally with the American Cancer Society, BeTheMatch, Leukemia & Lymphoma Society, and the Community Oncology Alliance. He was the Keynote Speaker for Canada’s Young Adults with Cancer’s national survivor conference in 2021 and was awarded Business Report’s Forty under 40 as the only physician recipient of the 2021 class. Dr. Juneja has a passion for education and believes that the knowledge gained through collaboration between patients and professionals is essential to empower healthier and more confident lives.

About xCures

xCures operates a precision oncology platform that includes direct-to-patient and direct-to-physician portals. The platform uses Artificial Intelligence/Machine Learning algorithms and Natural Language Processing to identify the most promising treatment options for advanced cancer patients. 

The platform supports tumor boards and captures valuable data to help accelerate the development of promising new cancer drugs, expand the approved uses of existing drugs, and demonstrate value for reimbursement. For more information, visit www.xcures.com or contact info@xcures.com.

xCures Webinar: Implications of new FDA draft guidance on real-world data explained

TORONTO (PRWEB) DECEMBER 01, 2021

The FDA has issued two new draft guidance documents on the use and structure of real-world data in regulatory decision-making. While real-world data has been around for many years, in this webinar the xCures speakers will recap the guidance and discuss what this means for the use of real-world data going forward. In particular, they will discuss the key requirements for real-world data to be suitable for regulatory decision-making and how those requirements differ from traditional uses of real-world data.

More at: https://www.prweb.com/releases/implications_of_new_fda_draft_guidance_on_real_world_data_explained_in_upcoming_webinar_hosted_by_xtalks/prweb18364230.htm

xCures presents the results of their oncology platform at the 2021 SNO Annual Meeting

xCures’ poster at the SNO meeting will show results from their XCELSIOR platform of real-world datasets and clinical outcomes in CNS cancer patients.

Today, xCures announced their poster presentation at the 26th Annual Meeting of the Society for Neuro-Oncology, held from the 18th to the 21st of November. The Society for Neuro-Oncology (SNO) is a multidisciplinary society of healthcare professionals dedicated to promoting advances in neuro-oncology through research and education. Their annual meeting features research and educational sessions on brain tumors, including the latest on diagnosis and treatments.

xCures’ poster presentation, entitled XCELSIOR: A real-time, real-world learning platform for patients with advanced cancer, will show clinical outcomes of real-world datasets from over 400 central nervous system (CNS) cancer patients and approximately 250 glioblastoma patients. XCELSIOR is a direct-to-patient evidence-based platform leveraging a nationwide observational research protocol. The platform allows for continuous learning towards informing treatment decisions by aggregating, normalizing, and analyzing N-of-1 clinical outcomes from anywhere in the country.

At the conference, xCures will discuss their real-time learning infrastructure and present results of clinical case studies for pharma and non-profit groups, including more than 100 reported virtual tumor boards. Outcomes shown will be from real-world evidence generated from hundreds of patients with CNS cancers that xCures has helped in partnership with Cancer Commons and the Musella Foundation.

“I look forward to connecting with colleagues and presenting our first analysis of real-world clinical outcomes of CNS cancer patients from our observational registry, including a preliminary analysis of patients that received immune checkpoint inhibitors,” stated Tim Stuhlmiller, VP of Scientific and Medical Affairs at xCures. “It is inspiring to see our approach to gather and analyze real-world data in real time via patient participation in a nationwide observational research protocol yield evidence-based insights.”

Al Musella, President of the Musella Foundation, said, “With the launch of their provider portal xDECIDE, the xCures platform offers a major opportunity for oncologists all over the country to collaborate on observational research without the burden of data entry. The CNS dataset presented at the conference provides a foundation for ongoing clinical research to identify the most promising new combinations of therapies in glioblastoma.”

“Cancer Commons’ close partnership with xCures, the Musella Foundation, and the expert physician advisers that serve on our virtual tumor boards has helped inform brain cancer patients across the U.S. about treatment options specific to their case. The data presented here demonstrates our first steps towards building a ‘learning health system’ that we hope will change care for brain cancer patients, tightly integrate clinical care and research, and help us learn from each individual’s experience,” said Matt Warner, Scientist at Cancer Commons.

For more information, visit the poster session on Friday, November 19th from 7:30-9:30 pm EST in Exhibit Hall D, or attend the live presentation of the xCures platform and preliminary RWD on CNS cancers on Saturday, November 20th at 1 pm EST in Room 309 in the Hynes convention center.

About xCures
xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com or contact info@xcures.com.

About the Musella Foundation for Brain Tumor Research & Information, Inc
The Musella Foundation is a 501(c)3 nonprofit public charity dedicated to helping brain tumor patients through emotional and financial support, education, advocacy and raising money for brain tumor research. For more information, visit www.virtualtrials.org

About Cancer Commons
Cancer Commons is a nonprofit that helps people with all types of cancer identify and access treatments and resources that best match their goals and needs. Our highly customized service connects patients with a collaborative network of nurse navigators, PhD scientists, and national cancer experts. For more information, visit www.cancercommons.org or contact info@cancercommons.org

This release also can be seen at https://www.einpresswire.com/article/556094277/xcures-presents-the-results-of-their-oncology-platform-at-the-2021-sno-annual-meeting

xCures hosts xDECIDE webinars

xCures is inviting the oncology community to register for a 25-minute webinar introducing a new clinical decision support tool: xDECIDE.  Oncology providers now have access to a toolkit that offers tailored recommendations for treatment options and personalized patient health summaries.  To accompany the launch of the platform, Dr. Juneja discusses what these tools are and how they can help your practice. 

This webinar is designed for Physicians, Pharmacists, Nurse Practitioners, Physician Assistants, and Nurses who care for oncology patients. 

MEETING DATES – REGISTRATION

AGENDA

Why oncology providers benefit from decision support tools (xDECIDE)

  • The 15-minute problem
  • Complexity in oncology care

xDECIDE for providers

  • Personalized Oncology Options Report
  • Patient cancer journey (personalized health record)
  • How these tools help your practice and your patients

Q&A

Dr. Sanjay Juneja is Chief of Oncology Service Line at Baton Rouge General Hospital.  Dr. Juneja received his medical degree from Louisiana State University, Internal Medicine residency at Louisiana State University Health Sciences Center, and his fellowship in Hematology & Oncology at the Feist-Weiller Cancer Center.

ABOUT XCURES

xCures creates personalized oncology decision support tools and clinical trial assistance.  The xCures platform captures Real World Evidence (RWE) from patients being treated in clinical trials, compassionate use and managed access programs, virtual and decentralized studies, investigator-initiated studies, and even N-of-1 clinical studies.

xCures technology solutions put the patient first, providing meaningful access to experimental drugs and facilitating oncologist-led clinical research. 

HELPFUL LINKS

Providers and staff users may create new accounts at: https://provider.xcures.com/signup

Patients register here:
https://patient.xcures.com/signup

For questions or comments contact:

xCures launches xDECIDE to help oncologists find better treatment options for their patients

Portal helps oncologists find the most recent and relevant therapeutic options for advanced cancer patients so they can focus on treatment evaluation

xCures announced today the release of xDECIDE, the latest in the company’s suite of tools to empower oncologists and their teams to identify the most suitable, personalized treatment options for advanced cancer patients more efficiently. Through xDECIDE, providers may add patients and review their cases via a consolidated platform, saving them time while ensuring and supporting robust consideration of potential treatment options.

Whether working in a community setting or in larger institutions, oncologists typically struggle to keep up with their caseloads. Individual case review and treatment options research are time-consuming tasks, and no corners can be cut. xDECIDE’s goal is to save oncologists and their staff members a significant amount of that time by leveraging xCures’ core technology to expedite case preparation and research, including record collection, standardization, structuring, and expert interpretation of the records. The result is that when patients arrive for a visit (and/or return for future visits), both provider and patient are assured by the mutual understanding of the patient’s case history. Also reassuring is the fact that expert research has been conducted and presented for discussion and that all possible options have been evaluated.

xCures’ insights are generated for registered patients by two deliverables: a Cancer Journey and a Treatment Options Report. The patient’s Cancer Journey is a visual overview of their case history, assembled from source medical records compiled seamlessly from all institutions where the patient has received prior care. The Treatment Options Report provides a rank-ordered set of treatments for consideration, with supporting medical rationales and information regarding therapy access. The options themselves are chosen from a library of potential therapies, including those that go beyond standard of care and guidelines-based management, and even beyond clinical trial matching. The most promising treatments are identified and presented, even when non-traditional methods are needed to access those treatments (e.g., compassionate use program enrollment for an experimental treatment, or; patient assistance for access to a drug or drug combination outside of its primary indication).

Cancer Journeys and Treatment Options Reports are available to patients and their providers at no cost — patients participate with their data, and providers receive obligation-free information for any registered patient who has identified them as their treating oncologist. Both patients and linked providers receive access to xCures’ reports simultaneously, allowing for guided review and discussion.

A patient’s Treatment Options Report is generated through a combination of xCures’ technology, overseen by an expert team of Ph.D. scientists. It takes into account patient features, a broad set of patient outcomes data, expert recommendations, and insights from virtual tumor boards, public data sources, and an active learning network. Through xDECIDE, providers also have an opportunity to contribute to the refinement of xCures’ technology by making treatment decisions that feedback into xCures’ ever-growing knowledge base.

Providers who have collaborated with xCures via their xACCESS platform (e.g., expanded/managed access program) will see the xDECIDE toolset as an adjunct feature in their portal. As of today’s general availability of xDECIDE, all providers and staff users may also create new accounts via the following link: https://provider.xcures.com/signup To access these same resources as a patient, please register here: https://patient.xcures.com/signup

Jaime Leandro Foundation treats first cancer patient with personalized neoantigen peptide vaccine under expanded access through xCures

First-of-its-kind consortium enables cancer patients to receive anticancer vaccine therapy through compassionate use.

The Jaime Leandro Foundation for Therapeutic Cancer Vaccines (JLF) and partners announce the treatment of the first cancer patient with a personalized neoantigen vaccine through a self-pay compassionate use program.

JLF is a 501(c)3 non-profit organization whose mission is to make personalized anticancer vaccines available to patients with limited or no treatment options. Although neoantigen vaccines are not currently FDA approved, preliminary data is supportive of their use via compassionate access.

Personalized neoantigen vaccines are directed at tumor-specific mutation targets called neoantigens and leverage vaccine technology approaches to boost immune responses to a patient’s tumor. Although personalized neoantigen vaccines are very promising and have shown a favorable safety profile, their development and administration are hampered by regulatory, intellectual property, and clinical science obstacles. JLF has therefore partnered with multiple companies and institutions to bring these promising neoantigen vaccines directly to patients and their physicians.

By accelerating progress, informing patients, and enabling treatment, JLF and partners have worked diligently to help cancer patients and their clinicians overcome limited access to cancer vaccines through traditional trials. JLF has partnered with Washington University School of Medicine in St. Louis to use their pVAC-Seq algorithm, an important technology for the selection of neoantigens in the design of the vaccines. Of the many instrumental partners, key steps of vaccine design, manufacture, and patient treatment are provided by ennov1, CSBio, and xCures.

“We are delighted that xCures’ backend technology, regulatory know-how, and partnerships, enable cancer patients to access novel treatments while providing important real-world data,” said Mika Newton, CEO of xCures. “By partnering with JLF we enabled the use of a personalized neoantigen vaccine under compassionate use/expanded access.”

“We are thrilled to collaborate with JLF, and partners to ensure efficient analysis, optimal vaccine design and secure storage through our cloud-based platform and genomic technology,” said James Inglis-Jones, Chairperson of ennov1.

“It’s exciting to contribute with CSBio’s peptide and instrumentation manufacturing technology towards manufacturing a fully personalized anticancer peptide vaccine,” stated the CEO of CSBio, Jason Chang.

After a long process starting in fall 2020, the FDA approved treatment for the first two patients in the Spring of 2021. “We are very pleased to announce the initiation of treatment of the first cancer patient at Providence Saint John’s Health Center in Santa Monica, CA under the care of Dr. Santosh Kesari,” stated JLF President, William Hoos.

The patient’s husband praised this new pathway to treatment. “JLF and partners allowed us the option to pursue a treatment we wanted, a cancer therapy based on current research, trials, and science.” said Brad C.  Through cancer vaccines, we now have hope for more time, better chance for survival, and hopefully a roadmap for others to follow as well.”

To learn more, visit www.jlfvaccine.org

About the Jaime Leandro Foundation

The Jaime Leandro Foundation for Therapeutic Cancer Vaccines (JLF) is a 501(c)3 nonprofit organization that organizes the complex process necessary to give patients and doctors access to personalized neoantigen vaccines through self-pay compassionate access. This pioneering model establishes a consortium of partners that include ennov1, CSBio, xCures and Washington University in St. Louis School of Medicine. To learn more, visit www.jlfvaccine.org

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com or contact info@xcures.com

About ennov1

ennov1 empowers cancer patients to identify personalized treatment options created from their genomic data. Our cloud-based platform provides a clear way to manage your entire cancer journey from diagnosis and disease progression through treatment response and regression. https://www.ennov1.com

About CSBio

CSBio is a leading peptide and instrumentation manufacturing company located on the edge of Silicon Valley in Menlo Park, California. Since 1993, CSBio has been providing high quality custom peptides, cGMP peptides and automated peptide synthesizers to the global pharmaceutical community. CSBio peptide products and instrumentation can be found in production laboratories and pharmaceutical companies worldwide. https://www.csbio.com

About Providence St. Johns Health Center

For over 75 years, Saint John’s Health Center has provided the Los Angeles community an amazing array of medical specialties and sub-specialties. Services are provided with an unparalleled standard of care, and our dedication to each and every patient has earned a reputation for clinical excellence and award-winning care. https://www.providence.org/locations/saint-johns-health-center

xCures raises $12.69 million in Series A funding for their AI-powered precision oncology platform

xCures has helped 1000+ advanced cancer patients and their oncologists with treatment options and recently enabled direct access to the platform through xINFORM

Oakland, June 23rd, 2021 (PRNewswire) – xCures Inc., the leader in the patient-centric use of artificial intelligence (AI) and predictive modeling, announced today that it has raised $12.69 million in Series A funding. This investment, led by Boehringer Ingelheim Venture Fund and joined by Vanedge Capital, Harmonix Fund, Metaplanet, as well as other investors, will be used to accelerate adoption and further development of xCures’ AI-Powered platform for precision oncology decision making.

The xCures platform transforms complex unstructured medical data directly from the patient’s medical records into structured data suitable for analysis and machine learning. The AI engine then actively cross-references this data against a vast digital library of oncology data to match patients with potential treatments and predict outcomes, thereby empowering patients as well as their oncologists to make more informed and effective treatment decisions.

“This new investment enables us to leverage our experience in helping over 1000 patients on our platform to dramatically increase both platform usage and the insights we are generating,” stated Mika Newton, CEO of xCures. “Working with the Boehringer Ingelheim Venture Fund and our other investors, we are leading the field of patient-centric research, AI-powered clinical decision support, and prospectively generating regulatory-grade real-world evidence.”

xCures has developed the infrastructure and products to directly engage patients and access their raw unstructured medical records from anywhere in the United States. These records are then processed into structured data and stored in a HIPAA and CFR Part 11 compliant system. Patients and their physicians receive a crisp summary of their case in the form of a Cancer Journey. The platform then integrates knowledge and insights from this real-world evidence into xINFORM, providing powerful AI-driven clinical decision support tools. Also, the acquired real-world evidence is helpful for biopharmaceutical companies and payors to accelerate novel therapies and guide the optimization of precision medicine approaches to cancer treatment.

“The Boehringer Ingelheim Venture Fund sees the potential of the xCures platform to provide valuable options for advanced cancer patients, while at the same time, generating real-world evidence that could lead to important therapeutic insights,” said Mark Ralph, Executive Director of the Boehringer Ingelheim Venture Fund focused on Digital Health Investments, and who is joining the xCures Board of Directors. “We’re confident that xCures will continue to develop their platform and work to make a meaningful impact for patients.”

About Boehringer Ingelheim Venture Fund

The Boehringer Ingelheim Venture Fund is the strategic venture fund of the Boehringer Ingelheim Corporation. Since 2010, we invest in pioneering science that offers the potential to provide a significant benefit for our patients. Innovation is not restricted by geography; therefore, we invest worldwide.

About xCures, Inc.

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com or contact info@xcures.com 

xCures provides early access to xINFORM

Today, xCures enabled early access to xINFORM, an A.I.-powered platform for advanced cancer patients to identify personalized treatment options to discuss with their doctors.

xINFORM is available at no charge. Patients participate with their data and receive treatment options that combine the leading thinking in precision medicine, patient preferences, and access mechanisms.

Patients with a late-stage diagnosis, who have exhausted the standard of care or can’t tolerate the standard of care, often have a less than 1 in 2 chance of 5-year survival. These patients and their caregivers have an urgent need to prioritize the best potential treatment options.

Understanding the complex field of precision medicine and emerging therapeutic approaches is daunting. Every patient is unique.

Through xINFORM, xCures helps patients find options that include combinations of existing therapeutic approaches and investigational therapies. xINFORM delivers knowledge on access mechanisms such as rationales for the use of medications in new indications, clinical trials, and expanded access (compassionate use) that empowers patients and their doctors to pursue the options they choose efficiently.

xINFORM is available to those who follow a simple registration process (<5 minutes), allowing xCures to gather and structure relevant medical records using artificial intelligence. The xCures A.I.-powered platform, combined with insights from leading oncologists and cancer biologists, then generates a comprehensive Cancer Journey and a personalized Treatment Options Report.

The report lists treatment options and rationales based on the latest clinical evidence, trials, and knowledge accumulated from how other patients responded to the treatment options they have pursued. The documents are intended to be shared with oncologists and the patient’s care team for review.

“xCures’ technology platform has been built on the experience of the best patient navigation and information services available. By leveraging the experience of thousands of patient journeys, we developed the right operating infrastructure and offered this service in partnership with patient advocacy organizations for several years. Now, with xINFORM, we are very excited to make the powerful platform we have built directly available to patients,” said Mika Newton, CEO of xCures. “Our clinical decision support tools give both treating oncologists and patients more time to discuss a prioritized set of treatment options, eliminating countless hours of complex research.”

More information and sign up at: www.xcures.com/patients-providers 

xCures partners with FibroFighters to launch a real-time learning platform for Fibrolamellar Hepatocellular Carcinoma

Collection and analysis of real-time data about Fibrolamellar aim to deliver essential information for doctors and patients about this rare form of liver cancer

Today, xCures announced their collaboration with the FibroFighters Foundation to launch a real-time learning platform for the Fibrolamellar Hepatocellular Carcinoma (FLHCC) community. FLHCC is a rare cancer primarily affecting adolescents and young adults. With an annual incidence of fewer than 300 cases, little is known regarding the best treatment options.

The xCures platform is a direct-to-patient research program that brings together patients, clinicians, patient advocates, and researchers, to accelerate the understanding of cancers and find better treatments faster.

Tom Stockwell, Executive Director of FibroFighters commented “We are very excited to be working with xCures on this important project”. “This platform will have an immediate impact across many of our patients’ lives.” He added, “I only wish this extremely valuable tool could have been available during my son’s fight.” Tom has dedicated his life to helping FLHCC patients and families.

“xCures, FibroFighters, and the entire Fibrolamellar patient community are working together to advance knowledge about FLHCC across the country and around the world,” stated Mika Newton, xCures’ CEO. “This partnership will leverage access to leading therapeutics, diagnostics, and algorithms to improve patient outcomes at the point of care and provide much needed real-time data for doctors treating this rare cancer.”

For FLHCC patients, xCures integrates medical records into a clear patient summary report suitable for sharing with their oncologist, including their case summary, a list of top options, the rationale supporting each recommendation, and how to access the options.

Treatment options are informed by real-world data collected on the xCures platform, learning from the experiences of all FLHCC patients, and using AI algorithms to better understand which treatments work better for different FLHCC patients and why. Novel options and therapeutic rationales are sourced from expert oncologists and key opinion leaders in treatment of FLHCC.

xCures also helps patients access treatment options through trial matching, managed access, compassionate use programs, and by supporting insurance coverage of treatments with data. At the patient’s request, xCures may also convene a Virtual Tumor Board (VTB) where nationally recognized cancer experts further refine the xCures options summary based on a discussion of the patient’s personal medical history and preferences.

xCures and FibroFighters are actively assembling this expert panel for the Fibrolamellar community.

About FibroFighters Foundation

FibroFighters is a non-profit 501c3 patient centric advocacy and education organization dedicated to helping patients and caregivers with Fibrolamellar Hepatocellular Carcinoma (FLHCC) find, evaluate, and access the best possible treatment options and fund key pilot research studies to advance targeted translational projects with the ultimate goal of helping to discover the cure.

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com or contact info@xcures.com

UPDATE May 25, 2021: Patients with Fibrolamellar can get more information on how to access the platform at: https://xcures.com/details/fibrolamellar/

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This news was also released on EIN Presswire

xCures partners with CureScience to make leading translational research available to advanced cancer patients

Doctors and patients will benefit from the integration of xCures’ patient-oriented tracking infrastructure and CureScience’s precision medicine tools

Today, xCures announced its partnership with CureScienceTM so that patients across the US can have access to leading translational science approaches through a decentralized clinical research platform.

The xCures platform will track outcomes and clinical endpoints to validate CureScience’s assays and research protocols, thereby leveraging CureScience’s diagnostic assays and growing precision medicine resources. This synergy will be highly beneficial for patients and doctors dealing with advanced cancer by recognizing and targeting specific patients and patient populations that may benefit from a particular test or treatment.

“xCures’ collaboration with CureScience presents a significant step towards reaching our mutual goal to help advanced cancer patients,” stated Mika Newton, xCures’ CEO. “Together, we will be able to identify better treatments and treatment regimens through the use of real-world data, scalable technologies, as well as patient advocacy and empowerment.”

Besides the benefits this collaboration can deliver to patients and doctors, it can also provide insight into novel assays for CureScience to develop. Results obtained will be key for pharmaceutical and biotechnology companies focused on cancer therapeutics and diagnostics and enable negotiations of broader access to investigational and approved therapies.

“One of our goals is to empower patients to make informed decisions. A collaboration with xCures on patient-facing and outcomes tracking infrastructure provides a significant value towards this goal,” stated Shashaanka Ashili, CEO of CureScience. “This collaboration provides an opportunity to identify and implement joint clinical and translational opportunities that will lead towards achieving personalized precision medicine goals.”

About CureScienceTM Institute

CureScience is a San Diego based organization dedicated to developing curative therapies through a pre-emptive and personalized approach based on a) early diagnosis, b) immunology, and c) regenerative medicine. Our work is focused on accelerating the translation through in-house research, establishing disease-centric ThinkTanks, and building a patient-centric ecosystem.

About xCures

xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com or contact info@xcures.com.

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This news was was also released on EIN Presswire

xCures launches xACCESS for Providers

A.I.-assisted portal makes it easier for healthcare providers to enroll cancer patients in managed access programs

Today, xCures Inc. launched xACCESS for Providers – a portal for their artificial intelligence (A.I.)-assisted clinical study platform. The HIPAA-compliant portal enables healthcare providers to easily enroll patients in one of xCures’ managed access programs.

Typically, to enroll patients in managed access programs, oncologists and their staff must spend countless hours interacting with administrators to sign required documentation, share supporting medical records, and monitor application status. xACCESS for Providers streamlines this process for both providers and patients, resulting in significantly faster enrollment.

“Making it seamless for healthcare providers to enroll their patients in one of our managed access programs is vital to helping patients access the therapies they urgently need,” said Mika Newton, xCures’ CEO. “This is our first of many investments into strengthening our relationships with healthcare providers as we expand the portfolio of products running on our AI-assisted platform.”

The xACCESS registration module enables rapid scaling of patient enrollment by eliminating bottlenecks in eConsenting and obtaining medical records—benefitting not only patients and physicians, but also researchers who have partnered with xCures to run managed access programs via xACCESS. The real-world evidence generated by these programs supports assessment of safety, efficacy, and utility of investigational and FDA-approved cancer therapies.

The xACCESS module will be used for all clinical studies and programs available on the xCures platform, including a compassionate use program for ulixertinib (BVD-523), which is currently enrolling patients with MAPK pathway-aberrant cancer, as well as a medical food study for patients currently being treated for advanced pancreatic ductal adenocarcinoma (PDAC).

Several more studies and managed access programs will be added to xACCESS in the next few months.

xCures announces collaboration with CancerCompass to better support patients and caregivers through their cancer journey

Today, xCures announced their collaboration with CancerCompass, allowing consumers who contact CancerCompass to access the xCures’ platform and services.

“xCures partnering with CancerCompass is a significant step toward improving access to personalized knowledge about advanced cancer treatment options,” stated Mika Newton, xCures’ CEO. “This is important progress in our mission to broaden the availability of our comprehensive cancer case review services, positively affecting the largest number of cancer patients and their physicians.”

Consumers who purchase xCures’ comprehensive cancer case review service benefit from the xCures team organizing and structuring their medical records into high quality “Cancer Journey” patient summaries. These summaries are reviewed by xCures’ clinical scientists and utilized to identify appropriate treatment possibilities. For this, a proprietary options library, encompassing a highly curated set of novel therapies and multi-drug combinations vetted by leading oncologists and cancer scientists, will be referenced. xCures provides each patient with a summary report, suitable for sharing with their oncologist, consisting of a case summary, a list of top options, the rationale supporting each recommendation, and how to access the options.

When needed, xCures will also help patients access their preferred options, including contacting clinical trial sites, obtaining investigational therapies through managed access and compassionate use programs, and petitioning for insurance coverage for off-label use of approved drugs. At the patient’s request, xCures may also convene a Virtual Tumor Board (VTB) where nationally recognized cancer experts further refine the xCures options summary based on a discussion of the patient’s personal medical history and preferences. VTBs are currently available for brain and pancreatic cancers and are planned for other cancers shortly.

“At CancerCompass, we believe that cancer is personal and that treatment options and journeys should be individualized to align with each patient’s needs and preferences,” stated Lisa Keane, Co-Founder and Chief Operating Officer of CancerCompass. “Our collaboration with xCures is so well aligned with our mission to empower patients and caregivers throughout their cancer experience.”

About CancerCompass
CancerCompass is the first direct-to-consumer oncology platform to inform and empower consumers, patients, and caregivers through every step of their cancer journey, from prevention and wellness to diagnosis, treatment, survivorship and end of life care. CancerCompass is a trusted resource, matching patients to the right information, services, and care for them, based on their individual needs and preferences. For more information, please call (844) 4MY-HLTH or visit www.cancercompass.com.

About xCures
xCures Inc. operates an AI-assisted platform that connects cancer patients/physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com and/or contact info@xcures.com.

xCures Joins Decentralized Trials & Research Alliance (DTRA) to Democratize and Accelerate Clinical Trials

New Global Industry Coalition Aims to Dramatically Increase Access for All Patients Populations in Clinical Trials and Research

December 23, 2020 – xCures joins a historic alliance of fifty life sciences and healthcare organizations that seeks to accelerate the broad adoption of patient-focused, decentralized clinical trials and research. The “Decentralized Trials & Research Alliance (DTRA),” which launched December 10th, 2020, plans to unite industry stakeholders, including healthcare companies, regulators, patient groups, and research organizations with a singular mission to make clinical trial participation widely accessible by advancing policies, research practices and new technologies in decentralized clinical research.

“xCures is pleased to become a founding member of the Alliance. It enables new levels of collaboration and partnering to put patients first,” said Mika Newton, CEO of xCures. “Prospective patient-centric decentralized trials and generating regulatory grade real-world evidence are playing an ever more important role in both development and commercialization of cancer therapies.”

“We are extremely gratified to welcome xCures to the ‘Decentralized Trials & Research Alliance,’ said Amir Kalali, MD, founder of several collaborative life science communities and co-convenor of DTRA. “By advancing decentralized research, we can make the clinical trial process more patient-focused, increase trial efficiency, and encourage the use of technologies. We are excited by xCures commitment to embracing decentralized trials and to changing the culture that has been the rate limiter to innovation.”

Experts estimate that COVID-19 may set back non-pandemic clinical trials by several years due to prospective patients’ inability or reluctance to schedule visits at physical research locations. Decentralized approaches to conducting research facilitate participation by a more diverse patient population and could ease COVID-19-imposed difficulties for both patients and clinical investigators. Inclusion of representative patient populations in clinical trials by race, age, and geographic location has long been an operational challenge.  COVID-19 has amplified the disparities and inclusion biases that have become hurdles for potential trial participants.

“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives – and by taking part in the DTRA, xCures is demonstrating its leadership to drive change,” said Craig Lipset, DTRA co-convener, clinical innovation advisor, and a pioneer in decentralized trials.  “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders from pharma companies, regulators, technology leaders, and patient communities, we can remove remaining barriers to adoption and impact patients today.”

xCures joins with its peer DTRA Member organizations to provide expertise to identify and address gaps and needs and advance best practices through effective education and communication. (Member Organization) urges other organizations interested in taking part to visit DTRA.org

ABOUT DTRA:

The Decentralized Trials & Research Alliance (DTRA) was convened to enable collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research. It works to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. Follow DTRA on Twitter and LinkedIn for more information.

ABOUT XCURES

xCures Inc. operates an AI-assisted clinical platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies, expanded access programs, and decentralized trials. For more information, visit www.xcures.com and or contact info@xcures.com.

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xCures launches xACCESS – A new module in their AI-assisted clinical platform

The new registration module facilitates expanded access to novel therapies for patients with advanced cancer while accelerating the generation of real-world data on safety and efficacy.

SAN FRANCISCO, CA, NOVEMBER 17. Today, xCures Inc. is launching xACCESS – a new registration module for their AI-assisted clinical study platform. The module is used to enroll cancer patients and empower them, and their physicians, to make informed decisions and learn about access to treatment programs. The xCures platform uses a Master Observational Registry to efficiently run a wide variety of oncology studies and decentralized trials, prospectively generating real-world evidence.

“xACCESS is xCures’ first patient-centric technology module, onboarding patients directly to our sponsored studies and partner programs,” stated Mika Newton, xCures’ CEO. “This is an important milestone on our journey to make the cancer treatment ecosystem work better for patients and facilitating access to the best treatment options.”

The xACCESS registration module enables rapid scaling by eliminating bottlenecks in eConsenting and acquiring medical records, providing benefits to patients, physicians, partners, payers, sponsors, and investors. The resulting Real-World Evidence (RWE) supports the assessment of safety, efficacy, and utility of investigational and approved cancer therapies.

The xACCESS module will be used for all clinical studies and programs available on the xCures platform, including the recently announced Compassionate Use program for ulixertinib (BVD-523), currently enrolling patients with MAPK pathway aberrant cancer.

About xCures:

xCures Inc. operates an AI-assisted clinical platform that connects cancer patients/physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit www.xcures.com and or contact info@xcures.com

Original PRNewsWire release

xCures announces the launch of a Compassionate Use program for ulixertinib (BVD-523)

BioMed Valley Discoveries’ first-in-class ERK inhibitor available through newly opened compassionate use protocol.

September 28, 2020 – San Francisco, CA. – xCures, a clinical study platform provider, announces the US Food and Drug Administration (FDA) granted their IND for an intermediate Expanded Access Program (EAP) for the ERK inhibitor ulixertinib (BVD-523).

Ulixertinib is being developed by BioMed Valley Discoveries (BVD), a clinical stage biotechnology company, as a treatment for patients with MAPK pathway aberrant cancer, including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK, mutations.

The EAP is open across the United States to adolescent and adult cancer patients who cannot access an open clinical trial for the investigation of ulixertinib (BVD-523).

“xCures prospective real-world evidence generation capability transforms managed access programs such as the ulixertinib expanded access program by making them an efficient way for physicians and patients to gain access to promising therapies when clinical trials are not an option,” says Mika Newton, CEO of xCures, Inc. “xCures’ programs uniquely capture high-value evidence related to the safety and efficacy from this expanded set of patients.”

This intermediate-sized expanded access program (NCT04566393) is currently open and available for physicians interested in treating their patients. Physicians can reach out to expandedaccess@xcures.com for more information.  Patients can register and find more information at xcures.com/details/ulixertinib-xc/ or receive additional information via xCures patient advocacy partner Cancer Commons (www.cancercommons.org).

About ulixertinib (BVD-523):

Ulixertinib is a first-in-class and best-in-class small-molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway, including atypical (non-V600) BRAF alterations, for which there are currently no approved targeted agents.

About Expanded Access:

Expanded access, which is often called “compassionate use,” is the use of an unapproved drug for treatment of patients with serious or life-threatening illnesses outside of a clinical trial.  Expanded access is subject to oversight from the US FDA in accordance with the regulations outlined in 21 CFR 312.305.

About the Program:

This Expanded Access program provides ulixertinib for compassionate use in advanced cancer patients with a MAPK pathway-altered solid tumor(s) who have exhausted available therapies. The protocol aims to collect sufficient information about the patient’s treatment to provide a complete and accurate case report to health authorities using real-world data collection to assess response to treatment, safety, tolerability, and quality-of-life.

About xCures:

xCures Inc. provides clinical study platforms that use AI/ML algorithms to support tumor boards with the allocation of cancer patients to optimal treatment programs and clinical trials.  The xCures platform prospectively generates Real World Evidence for investigational and approved therapies. Patient EMR data is continuously collected, stored, and structured into a regulatory-grade format ready for use in submissions to the FDA. For more information, visit www.xcures.com and or contact info@xcures.com.

About BioMed Valley Discoveries (BVD):

BioMed Valley Discoveries is a clinical stage biotechnology company focused on addressing unmet medical needs in a variety of therapeutic and diagnostic areas. In addition to the ERK inhibitor, BVD’s portfolio includes an oncolytic bacteria that has completed enrollment for a Phase I study, a selective phosphoinositide 3-kinase gamma inhibitor in late preclinical testing, and two early-stage antibodies targeting the tumor microenvironment.

Operating since 2007, BioMed Valley Discoveries was established by Jim Stowers Jr., founder of the asset management firm American Century Investments, and his wife Virginia, to advance new medical innovations to improve the lives of patients with difficult-to-treat diseases. BVD is owned by a supporting organization of the Stowers Institute for Medical Research, a non-profit, basic biomedical research organization. Since 2000, the endowment of the Stowers Institute has received over $1.5 billion in dividend payments from American Century. The Institute has invested a portion of its endowment in BVD, whose profits accrue to the benefit of the Institute. For more information, visit https://www.biomed-valley.com.

(PRNewswire Release)

xCures together with Cancer Commons and a confidential partner, to launch a virtual medical food trial in patients with pancreatic cancer

San Francisco, CA, September 23, 2020. Today, xCures Inc., together with a confidential partner, is pleased to announce their launch of a medical food clinical trial. This study, to be led by Jennifer R. Grandis, M.D., aims to characterize a highly engineered medical food formulation as a foundation or component for treatment of patients with advanced pancreatic ductal adenocarcinoma.

Metastatic pancreatic cancer has an exceptionally low 5-year survival rate, remaining relatively unresponsive to chemotherapy options. Recent data suggests that specific components in certain foods may play a role in tumor growth. This trial aims to test a specific medical food formulation thought to benefit patients with pancreatic ductal adenocarcinoma, and to examine its effect on specific blood measures and metabolic health over time.

Patients are enrolled through partnership with Cancer Commons. The prospective, open-label, nonrandomized trial leverages xCures’ longitudinal registry (XCELSIOR) to aggregate data from patients across the country. This will be the first test of this medical food formulation in cancer patients and will evaluate it alongside standard-of-care chemotherapies. Since this trial is powered by xCures registry, patients do not need to switch doctors and can continue their typical treatment plan, just with the addition of the medical food formulation.

This study will evaluate the quality of life of patients regarding pain, energy levels, mood, and digestion. Measures will include body weight and composition, blood serum chemistry, circulating tumor markers, and impact of the diet on disease.

“We are excited to utilize xCures’ longitudinal outcomes registry and biomedical expertise to evaluate this novel approach to the treatment of pancreatic cancer” stated Mika Newton, CEO of xCures, Inc.

“This investigation will ideally help to characterize this formulation as a foundation or component of future treatment regimens for pancreatic cancer,” said Jennifer R. Grandis, M.D., principal investigator of the study, “and offer patients the opportunity to participate in a clinical trial”.

About xCures:

xCures Inc. provides a clinical study platform that prospectively generates Real World Evidence for investigational and approved interventions. Through patient advocacy partners such as Cancer Commons, xCures enrolls patients, and processes medical data. AI algorithms ensure that the patients are matched to the best programs on the study. Patient EMR data is continuously collected, stored and structured into a regulatory-grade format that is ready for direct use in submissions to the FDA. For more information, visit www.xcures.com or contact info@xcures.com.

About Cancer Commons:

Cancer Commons is a nonprofit patient advocacy organization that provides hope to advanced cancer patients by helping them identify and access their best possible treatment. Their highly customized experience connects patients with a collaborative network of nurse navigators, PhD scientists, and national experts. For more information, visit www.cancercommons.org

(PRNewswire Release)

BEAT19 crowd-sourcing study jump starts data collection for research to find effective treatments in battle against COVID-19

240 million Americans can play a vital role in the search for a vaccine or treatment by contributing critical data from home

SAN FRANCISCO – April 15, 2020 – xCures, a health technology company focused on the use of artificial intelligence, has released preliminary data from the company’s Behavior, Environment, And Treatments for COVID-19 (BEAT19) registry study, NCT04321811.  The study is designed to enable everyday people, regardless of their health status, to contribute directly to the development of coronavirus treatments. Since the approval of the BEAT19 registry by the Genetic Alliance’s independent review board (IRB) and program launch on March 29, BEAT19 has collected more than 6,000 daily surveys representing people across all 50 US states and several countries. The preliminary data demonstrated that BEAT19 can collect data from patients who are infected with COVID-19 while they are undergoing quarantine and provide clinical researchers with important insights into disease progression.

Most people will combat and recover from COVID-19 in their homes, isolated from their friends and family. Much of the information being collected today by the healthcare system when a person is interacting with their care team, leaving most data until that point unreported. BEAT19 is a way to learn about what is happening to the millions of people who experience COVID-19 outside a hospital. The BEAT19 data will be used to define the natural history of infection and to look for patterns, formulate and test hypotheses. For example, do people with high blood pressure who contract COVID-19 and take an ACE inhibitor fare better than people who take a beta blocker?

“The BEAT19 online trial has the potential to improve our understanding of COVID-19 and help public health experts make evidence-based decisions,” said Vikash Mansinghka, PhD, principal research scientist and principal investigator of the MIT Probabilistic Computing Project. “The data could inform critical research decisions, smooth the path for developing a vaccine, and reveal potential therapeutic options for COVID-19 patients and the healthcare professionals caring for them.”

“Our team has taken an initial look at the BEAT19 data and were able to quickly screen for anomalies. As BEAT19 enrollment grows, we may be able to identify early signals about risk factors and clinical presentations that can be confirmed or corrected by doctors,” added Ulrich Schaechtle, PhD, xCures-MIT BEAT19 collaboration research lead and MIT Probabilistic Computing Project scientist.  “The ability to rapidly assess the data accumulated in the registry means researchers can account for additional factors in their research for a vaccine and treatment, which is critical as the world races to find a solution for the millions of people affected by the COVID-19 pandemic.”

BEAT19 is designed to capture how people are feeling and learn from their experiences during COVID-19.  To really understand the infection, it is necessary to start tracking symptoms before people are diagnosed, to establish a baseline.  During the illness, many BEAT19 participants are taking medications for their ongoing conditions and some appear be taking novel treatments, such as Hydroxychloroquine (HCQ) + azithromycin. The registry is gathering and analyzing real-time information from real people about their daily COVID-19-related experiences. This approach is a proven and very efficient way to generate real-world effectiveness data on emerging therapies that can help guide clinical research.

“The ability to effectively crowd-source data in an effort to solve a global pandemic is proof of the impact health technology and innovation can have on our world,” said Erica Frank, MD, MPH, FACPM, Professor and Canada Research Chair in Preventive Medicine and Population Health, University of British Columbia:  “While the threat of COVID-19 continues, people can participate in finding a cure while practicing physical distancing and sheltering at home.  People-powered research can move faster than traditional approaches and bring together significant new insights from different areas of expertise to solve a massive global health problem.  It’s truly inspiring, and we are proud to volunteer for this effort.”

People, regardless of their current health status, can join BEAT19 by completing a simple enrollment survey and agreeing to participate through the study’s website. The data collected is de-identified to keep the data secure and private, then it is made available as a resource for researchers. As more biopharmaceutical companies begin researching COVID-19 vaccines and therapies, they need to access to vital disease-progression information that is usually only captured by care providers.

“In this unprecedented time, we need to move with urgency to focus resources where they will help people immediately,” said Mika Newton, chief executive officer of xCures, Inc. “Simply put, we knew researchers needed more and early data about COVID-19.  Our team recognized the possibility to apply our experience in accelerating clinical research to the battle at hand, and that doing this quickly could save many lives. The sooner we can answer the many open and important questions about COVID-19, the sooner we can get to our new normal. There is no cost to participate, and registrants can be proud that they acted and played their part in the clinical research needed to combat COVID-19. Together let’s Beat19!”

To join the fight against COVID-19, please visit the BEAT19 registry website at www.BEAT19.org  where you can find out more information about the study and can register to participate as a contributor or request information as a researcher.

About the BEAT19 Registry Study

BEAT19 is a people-powered study, registered on clinicaltrials.gov, designed to understand the natural history of the coronavirus infection before, during and after symptoms, and to understand how pre-existing conditions, medications, and other factors affect disease progression. The BEAT19 registry is used to gather knowledge about new treatments faster than can be done in clinical trials. Participants are everyday people, who might or might not have COVID-19. They all provide confidential data, using a short daily survey sent via email.

If new knowledge (a signal) emerges from the data, then participants whose data contributed to the signal may be contacted for approval to request additional information. This is only done if the knowledge merits deeper exploration.

For more information, or to participate in the study, please visit https://beat19.org/.

About xCures

xCures is a health technology and services company that operates an AI-assisted precision medicine platform that continuously learns from the experiences of all patients, on all treatments, all the time. The platform can determine the best individualized treatment options and services for patients, including access via reimbursement, clinical trials, and expanded-access support. By tightly integrating research and clinical care, xCures enables physicians to make better treatment decisions, patients to achieve superior outcomes, and bio-pharmas to slash the time and cost of developing drugs.

Oncology Pioneer xCures Names Experts to Advisory Boards

Prominence of Scientific and company Advisory Board signals attraction to xCures’ novel patient-centric approach to treatment and continuous learning for cancer

LOS ALTOS, CA, USA, October 10, 2019 — Today, xCures Inc. announced the appointment of members to its Scientific Advisory Board (SAB) and company Advisory Board. The SAB supports the work of xCures’ Virtual Tumor Boards in running patient-centered Perpetual Clinical Trials for oncology. xCures currently manages XCELSIOR, a Perpetual Trial collecting real-world data and patient-reported outcomes integrated with AI- and expert-supported Virtual Tumor Boards.
The company Advisory Board provides guidance to the company on technology and business issues. By implementing this precision oncology approach to the treatment of all cancer patients, on all therapies, all the time, xCures aims to develop deep insights into rapid improvements in the treatment of cancer patients.
More…

Integrating Clinical Research And Care In A Perpetual Trial

With attention focused on the difficulties associated with traditional oncologic clinical trials, xCures’ Perpetual Trial and the potential for a Real World Data-based learning ecosystem has gained attention. Recently, Diagnostic World News interviewed xCures CEO Mika Newton about Perpetual Trials, AI, and the future of accelerating treatment and knowledge in the development of cancer treatments. To see more, go to Diagnostic World News.

Oncology Expert Keith T. Flaherty, MD Named Chairman of xCures Scientific Advisory Board

Keith T. Flaherty, MD, has joined the xCures Scientific Advisory Board as Chairman. The Scientific Advisory Board supports the work of xCures’ Virtual Tumor Boards in running patient-centered “Perpetual Trials” for oncology. xCures currently runs XCELSIOR, a Perpetual Trial integrating real-world data and patient-reported outcomes with an AI-enhanced Virtual Tumor Board. By implementing this precision oncology approach to the treatment of all cancer patients, on all therapies, all the time, xCures aims to develop deep insight into rapid improvements in the treatment of cancer patients.

“Keith Flaherty brings unparalleled experience in targeted therapy and will be an invaluable addition to the essential activities of our Scientific Advisory Board as more and more we bring real world evidence and patient-centered approaches to research to bear for patients in their fights against cancer,” said Mika Newton, CEO of xCures.

The xCures Scientific Advisory Board’s efforts include developing a portfolio of leading drugs for each of the major molecular mechanisms/pathways driving cancer and providing these options as input for xCure’s Virtual Tumor Boards to consider when formulating treatment options for cancer patients and their doctors. In conjunction with the Advisory Board, xCures works to establish relationships with the manufacturers of those drugs to make them part of the company’s compassionate access compendium. This makes these options more readily available to patients and their physicians. The Scientific Advisory Board will also consider outside entities submitting their hypotheses or therapies as treatment options for considerations by the Virtual Tumor Boards.

“Defeating cancer demands new approaches that both capture and disseminate treatment information broadly and efficiently,” said Dr. Flaherty. “These approaches must take into account the fact that there are far too many rational treatments to try and that traditional trials are far too expensive. I am thrilled to work with xCures as they further develop a revolutionary platform that can rapidly evaluate new therapeutic options at a fraction of the time and cost of traditional trials.”

Keith Flaherty, MD, is Professor of Medicine at Harvard Medical School and Director of Clinical Research at the Massachusetts General Hospital Cancer Center, where he was named as the Richard Saltonstall Endowed Chair in Oncology.

Press Release

xCures to Implement an Intermediate Size Expanded Access Protocol for ONC201 in H3 K27M-Mutant Gliomas

LOS ALTOS, Calif., March 12, 2019 /PRNewswire/ — xCures and Cancer Commons are pleased to announce a collaboration with Oncoceutics to implement an Expanded Access program for ONC201. Part of this Expanded Access program is an intermediate size Expanded Access protocol for ONC201 in patients with H3 K27M-mutant glioma entitled “ONC018: Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline High Grade Gliomas” that was recently accepted by the U.S. Food and Drug Administration (FDA).

The H3 K27M mutation has been identified as an important prognostic indicator in aggressive midline gliomas that involve specific parts of the brain, including the thalamus, pons, or spinal cord. In 2016, the World Health Organization categorized any midline brain tumor that contains the H3 K27M mutation as the highest grade (IV) because the mutation confers such a poor prognosis. Beyond palliative radiation, no medical therapy has been shown to provide clinical benefit for patients with this mutation in their tumor. Pediatric patients are particularly impacted by this mutation, especially those with DIPG where 70-80% of the patients have the mutation.

Press Release