On January 10, 2025, Tyra Biosciences announced that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300. This clearance allows the company to proceed with a Phase 2 clinical trial, SURF302, for TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC).
FGFR3 is the most frequently altered gene in NMIBC, with 60-80% of IR NMIBC cases showing alterations, making it a targeted opportunity for TYRA-300. The company expects to initiate patient dosing in the SURF302 study during the second quarter of 2025, with initial three-month complete response data anticipated to follow.
Concurrently, Tyra Biosciences appointed Erik Goluboff, M.D., as Senior Vice President, Clinical Development, to lead the NMIBC program. Dr. Goluboff brings over thirty years of experience as an academic urologic oncologist and drug developer from Genentech/Roche and AstraZeneca, enhancing the company's clinical leadership.
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