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.

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