Tyra Biosciences Receives IND Clearance from FDA to Proceed with Phase 2 Study of TYRA-300 in Non-Muscle Invasive Bladder Cancer (SURF302)

Core Insights - Tyra Biosciences has received FDA clearance for its IND application for TYRA-300, allowing the initiation of a Phase 2 clinical trial for low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC) [1][4] - The company has appointed Dr. Erik Goluboff as SVP of Clinical Development to lead the NMIBC program, bringing over thirty years of experience in urologic oncology [1][4][5] - TYRA-300 is a first-in-class, oral FGFR3-selective inhibitor, targeting a significant patient population with FGFR3 alterations in NMIBC [2][8] Company Overview - Tyra Biosciences is a clinical-stage biotechnology company focused on developing precision medicines targeting FGFR biology, with its lead program being TYRA-300 [9] - The company utilizes its proprietary SNÅP platform for rapid drug design and has a differentiated pipeline with three clinical-stage programs [9] - TYRA-300 is also being evaluated for other indications, including pediatric achondroplasia and metastatic urothelial carcinoma [8][9] Clinical Development - The SURF302 study will enroll up to 90 participants with FGFR3-altered low-grade IR NMIBC, evaluating the efficacy and safety of TYRA-300 [3] - The primary endpoint of the study is the complete response rate at three months, with secondary endpoints including time to recurrence and progression-free survival [3] - Initial patient dosing is expected to begin in Q2 2025, with preliminary data anticipated shortly thereafter [1][4] Market Context - There are over 730,000 individuals living with bladder cancer in the U.S., with many suffering from IR NMIBC, highlighting a significant unmet medical need for better treatment options [6][7] - Current treatments involve invasive procedures and chemotherapy, which can adversely affect patients' quality of life, underscoring the importance of developing more tolerable therapies like TYRA-300 [7]