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

-TYRA appoints urologic oncologist, Erik Goluboff, M.D., as SVP, Clinical Development to lead NMIBC-

Excerpt from the Press Release:

CARLSBAD, Calif., Jan. 10, 2025 /PRNewswire/ — Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today that the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive bladder cancer (IR NMIBC).  This program will be led by newly appointed Dr. Erik Goluboff, SVP, Clinical Development of TYRA, who brings more than thirty years of experience as an academic urologic oncologist, principal investigator, practicing urologist and most recently Principal Medical Lead for GU/GI cancers at Genentech/Roche.     

TYRA-300 is a potential first-in-class, investigational, oral, FGFR3-selective inhibitor designed to avoid the toxicities associated with inhibition of FGFR1, FGFR2 and FGFR4, while being agnostic for the FGFR3 gatekeeper mutations.  FGFR3 is the most frequently altered gene in NMIBC, with 60-80% of IR NMIBC showing alterations. TYRA-300 is expected to be evaluated in three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia (ACH) and SURF301 for metastatic urothelial carcinoma (mUC).

SURF302 will be an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC.  The study will enroll up to 90 participants at multiple sites primarily in the United States.  Participants will be randomized initially to treatment with TYRA-300 at 50 mg once-daily (QD) (Cohort 1) or treatment with TYRA-300 at 60 mg QD (Cohort 2). Following a review of efficacy and safety, an additional dosing cohort may be evaluated.  The primary endpoint is complete response (CR) rate at three months.  Secondary endpoints include time to recurrence, the median duration of response, recurrence free survival (RFS), progression free survival (PFS), safety and tolerability.

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