On October 24, 2024, Tyra Biosciences announced positive interim clinical proof-of-concept data for TYRA-300 from its ongoing Phase 1/2 SURF301 study in patients with metastatic urothelial cancer (mUC). These results were presented in a late-breaking oral presentation at the 36th EORTC-NCI-AACR Symposium.
The data, with a cutoff date of August 15, 2024, showed encouraging anti-tumor activity in a heavily pre-treated patient population. Specifically, at doses of 90 mg once daily (QD) or higher, 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a confirmed partial response, alongside a 100% disease control rate and sustained duration of activity.
TYRA-300, an investigational oral FGFR3-selective inhibitor, also demonstrated favorable interim safety results across all QD doses, with infrequent toxicities typically associated with FGFR1 and FGFR2 inhibition. This safety profile is a key differentiator, as pan-FGFR inhibitors often face tolerability limitations.
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