TYRA-430 / Tyra Biosci - LARVOL DELTA

A multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431) (ESMO 2025) - P1 | "FGF19 signals through FGF receptor 4 (FGFR4), however, selective investigational FGFR4 inhibitors, such as fisogatinib and roblitinib have shown limited clinical efficacy. Part B Cohort 1 dose expansion will enroll approximately 40 patients with advanced HCC at RP2D(s), focusing on FGF19-positive patients; approximately 20 patients with FGFR3/4 altered solid tumors will be enrolled in Part B Cohort 2. The study is planned for approximately 25 centers in North America, Asia, and Europe."

Clinical • First-in-human • Metastases • P1 data • Brain Cancer • Hepatocellular Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • FGF19 • FGFR3 • FGFR4

Initiated Patient Dosing in Phase 1 Study - SURF431 (PRNewswire) - "TYRA-430 is an oral, investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. Patient dosing has commenced in SURF431, a Phase 1, multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (NCT06915753)."

Trial status • Hepatocellular Cancer

SURF431: Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Tyra Biosciences, Inc

New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor

Tyra Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights (PRNewswire) - "Upcoming Anticipated Milestones and Events: (i) SURF302: dose first NMIBC patient with TYRA-300 - Q2 2025; (ii) SURF431: dose first HCC patient with TYRA-430 - Q2 2025."

Trial status • Hepatocellular Cancer • Urothelial Cancer

TYRA-430: First reversible FGFR4/3 inhibitor designed to overcome current challenges in FGF19-driven hepatocellular carcinoma treatment. (ASCO-GI 2025) - "In vitro data showed that TYRA-430 displayed superior potency over the reversible multi-kinase inhibitors sorafenib and lenvatinib, and the covalent FGFR4 inhibitors fisogatinib (BLU-554) and roblitinib (FGF401) in KLB/FGF-19/FGFR3/4 driven models of HCC (Hep3B, HuH-7, and JHH-7 cells). TYRA-430 was active and potent in multiple KLB/FGF-19/FGFR3/4 models of human hepatocellular carcinoma in vitro and in vivo. Moreover, TYRA-430 displayed potent activity against known FGFR4 resistance mutations compared to covalent FGFR4-specific inhibitors in the clinic. TYRA-430 will be investigated in a Phase 1 clinical trial in hepatocellular carcinoma and other advanced solid tumors."

Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • FGF19 • FGFR3 • FGFR4

Tyra Biosciences Announces Poster Presentations at 2025 ASCO Gastrointestinal Cancers Symposium (PRNewswire) - "Tyra Biosciences, Inc...announced today that two abstracts were accepted for presentation at the 2025 ASCO Gastrointestinal Cancers Symposium (ASCO GI), taking place January 23-25, 2025, in San Francisco, CA."

P1 data • Preclinical • Biliary Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Solid Tumor

Tyra Biosciences Reports Second Quarter 2024 Financial Results and Highlights (PRNewswire) - "TYRA announced today that the FDA cleared its IND to proceed with a Phase 1 clinical study of TYRA-430, an investigational, FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers. The Phase 1 study will be a multicenter, open-label, first-in-human study of TYRA-430 in advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations (SURF431)."

IND • New P1 trial • Hepatocellular Cancer