TYRA-430
- Generic Name
- TYRA-430
TYRA-300 Phase 2 Trial for Non-Muscle Invasive Bladder Cancer Gets FDA Green Light
• The FDA has cleared Tyra Biosciences' IND application for TYRA-300, allowing a Phase 2 trial in low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC).
• The SURF302 trial will evaluate the safety and efficacy of TYRA-300, an oral FGFR3-selective inhibitor, in patients with FGFR3-altered NMIBC.
• The open-label study will enroll up to 90 patients, with the primary endpoint being the complete response rate at 3 months, with patient dosing expected in Q2 2025.
• TYRA-300 is also being investigated in metastatic urothelial carcinoma (mUC) and pediatric achondroplasia, showing promising initial efficacy and tolerability.
Tyra Biosciences' TYRA-300 Shows Promise in Bladder Cancer and Achondroplasia
• Tyra Biosciences reported positive interim Phase 1/2 data for TYRA-300 in metastatic urothelial cancer (mUC), with a 54.5% confirmed partial response rate in FGFR3+ patients.
• The FDA cleared the IND for TYRA-300's Phase 2 study in pediatric achondroplasia (BEACH301), with the first patient expected to be dosed in Q1 2025.
• TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development.
• The company appointed Doug Warner, MD, as Chief Medical Officer and reported a cash position of $360.1 million, expected to last through at least 2026.
Tyra Biosciences' TYRA-300 Shows Promise in Metastatic Urothelial Cancer
• TYRA Biosciences reported positive interim results for TYRA-300 in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study, demonstrating notable anti-tumor activity.
• The company's IND was cleared for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301), with plans to initiate the study in Q1 2025.
• TYRA-300 is also on track for a Phase 2 IND submission for non-muscle invasive bladder cancer (NMIBC) by the end of 2024, expanding its clinical development.
• Doug Warner, MD, was appointed as Chief Medical Officer, bringing extensive experience in oncology and skeletal disease drug development to Tyra Biosciences.
FDA Clears Tyra Biosciences' TYRA-300 IND for Phase 2 Achondroplasia Trial
• The FDA has cleared Tyra Biosciences' IND application for TYRA-300, an oral FGFR3-selective inhibitor, to proceed with a Phase 2 trial in children with achondroplasia.
• The BEACH301 trial will be a multicenter, open-label, dose-escalation/expansion study evaluating TYRA-300 in children aged 3-10 with achondroplasia.
• TYRA-300 has received Orphan Drug and Rare Pediatric Designations from the FDA for treating achondroplasia, highlighting its potential impact on this rare condition.
Drug Development Updates
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