Tyra Biosciences’ TYRA-300 shows anti-tumor activity in proof-of-concept trial

Tyra Biosciences (TYRA) announced clinical proof-of-concept data for TYRA-300 in patients with metastatic urothelial – mUC – cancer from its ongoing SURF301 Phase 1/2 study. These data will be presented in a presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, October 23-25, 2024 in Barcelona, Spain. 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. Results showed “encouraging” preliminary anti-tumor activity observed in heavily pre-treated population. At greater than or equal to 90 mg QD, 6 out of 11 patients with FGFR3+ mUC achieved a confirmed partial response, with 100% disease control rate and sustained duration of activity. A 100% disease control rate was achieved for all patients at greater than or equal to 90 mg QD. “Positive” safety results were seen across all QD doses, with infrequent FGFR2/FGFR1-associated toxicities.