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Tyra Biosciences, xCures Launch Real-World Biomarker Study in FGFR-Mutated Bladder Cancer

NEW YORK – XCures said on Friday that it has partnered with Tyra Biosciences on a real-world biomarker study involving patients who have FGFR-mutated bladder cancer and received Janssen's Balversa (erdafitinib).

Within this Tyra-sponsored study, investigators will analyze circulating tumor DNA in patients' blood and urine samples, hoping to improve their knowledge of Balversa's efficacy and identify additional treatment options for patients once they relapse.

Balversa is US Food and Drug Administration-approved as a treatment for patients with advanced urothelial carcinoma harboring FGFR2 or FGFR3 mutations. In 2019, the FDA approved Qiagen's Therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic for the drug.

The findings will be useful to Tyra as it develops its own investigational FGFR3 inhibitor, TYRA-300, currently in preclinical studies. The Carlsbad, California-based firm believes TYRA-300 can address the limitations of currently approved FGFR inhibitors. Tyra CEO Todd Harris said in a statement that the firm hopes this real-world study "could yield valuable insights into FGFR-mutant biology and overall tumor progression in bladder cancer."

For its part of the collaboration, xCures will use its direct-to-patient artificial intelligence-enabled trial matching and decision support platform, which collects real-world evidence from decentralized studies.

The observational trial will use Resolution Bioscience's next-generation liquid-based assays for the ctDNA analyses and will enroll roughly 50 patients.