Tyra Biosciences, Inc. (Nasdaq: TYRA) has announced encouraging interim clinical proof-of-concept results for its lead candidate, TYRA-300, in metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study. The company also reported the FDA clearance of its Investigational New Drug (IND) application for a Phase 2 study of TYRA-300 in pediatric achondroplasia (BEACH301). These advancements mark significant progress in Tyra's development of next-generation precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology.
TYRA-300 Shows Anti-Tumor Activity in mUC
At the 36th EORTC-NCI-AACR (ENA) Symposium, Tyra presented interim data demonstrating that TYRA-300 achieved a 54.5% confirmed partial response (PR) rate in heavily pre-treated patients with FGFR3+ mUC at doses ≥ 90 mg once daily (QD). The study also reported a 100% disease control rate and sustained duration of activity. Importantly, the safety profile was favorable across all QD doses, with infrequent FGFR2/FGFR1-associated toxicities, which often limit the tolerability of pan-FGFR inhibitors. These results support the continued development of TYRA-300 for mUC, with the company prioritizing QD dosing in ongoing and future oncology studies.
Todd Harris, CEO of TYRA, stated, "These data provide clinical support that an FGFR3 inhibitor designed to be highly selective can deliver meaningful clinical benefit to heavily pretreated patients with cancer."
Advancing TYRA-300 in Achondroplasia
In October 2024, the FDA cleared Tyra's IND application for TYRA-300, allowing the initiation of a Phase 2 clinical trial (BEACH301) in children with achondroplasia. The study is a multicenter, open-label, dose-escalation/dose-expansion trial evaluating TYRA-300 in children aged 3 to 10 with open growth plates. The trial will enroll both treatment-naïve children and those who have previously received growth-accelerating therapies. Tyra anticipates dosing the first child in Q1 2025.
Expansion into NMIBC
Tyra is also planning to expand the clinical development of TYRA-300 into non-muscle invasive bladder cancer (NMIBC) to address the unmet needs in this patient population with an efficacious, orally available therapy. The company remains on track to submit an IND application for a Phase 2 study of TYRA-300 in NMIBC before the end of 2024.
Other Pipeline Developments
- TYRA-200: The Phase 1 SURF201 study (NCT06160752), evaluating TYRA-200 in previously treated and resistant FGFR2+ cholangiocarcinoma and other advanced solid tumors, continues to advance. TYRA-200 is an investigational FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations.
- TYRA-430: Following IND clearance, Tyra is continuing Phase 1 planning for TYRA-430, an investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study (SURF431) will focus on advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations.
Corporate Updates
Tyra appointed Doug Warner, MD, as Chief Medical Officer in September 2024. Dr. Warner brings over twenty years of clinical development leadership experience, including roles at Amgen and eFFECTOR Therapeutics.
As of September 30, 2024, Tyra reported cash, cash equivalents, and marketable securities of $360.1 million, which is expected to fund operations through at least 2026.
