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