Tyra Biosciences: TYRA-300 Shows Promise in Phase 1/2 SURF301 Study for Metastatic Urothelial Cancer

Tyra Biosciences, Inc. (TYRA), a clinical-stage biotechnology company, has reported interim clinical proof-of-concept data for TYRA-300, an investigational oral FGFR3-selective inhibitor, in its Phase 1/2 SURF301 study. The study is evaluating TYRA-300 in patients with metastatic urothelial cancer (mUC) harboring activating FGFR3 gene alterations.

TYRA-300 is a first-in-class, oral, selective FGFR3 inhibitor designed to address the limitations of current pan-FGFR inhibitors, such as erdafitinib, which can cause off-target toxicities and gatekeeper resistance mutations. TYRA-300's selectivity for FGFR3 allows it to avoid these toxicities and maintain efficacy against gatekeeper mutations.

The SURF301 study is a multicenter, open-label Phase 1/2 clinical trial designed to determine the optimal and maximum tolerated dose (MTD) of TYRA-300, as well as to evaluate its preliminary antitumor activity. The study is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations.

The interim data from the SURF301 study demonstrated that TYRA-300 was well-tolerated, with no dose-limiting toxicities observed at the highest dose level evaluated (1.8 mg/kg/day). Preliminary antitumor activity was observed in patients with FGFR3-altered mUC, with one patient achieving a partial response and several others experiencing stable disease.

The positive interim results from the SURF301 study support the continued development of TYRA-300 as a potential treatment for patients with mUC harboring activating FGFR3 gene alterations. The selective inhibition of FGFR3 by TYRA-300 may offer an improved safety profile and efficacy compared to pan-FGFR inhibitors.

In conclusion, Tyra Biosciences' TYRA-300 has shown promising interim results in the Phase 1/2 SURF301 study for metastatic urothelial cancer. The selective inhibition of FGFR3 by TYRA-300 may offer an improved safety profile and efficacy compared to pan-FGFR inhibitors. As the study continues, investors should monitor the progress of TYRA-300's development and its potential impact on the treatment landscape for mUC.