Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 11

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 11
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 partial response (PR). Preliminary data, as of the August 15, 2024 data cutoff, suggested TYRA-300 was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities. Dose optimization is ongoing in this study.    

SURF302 for NMIBC: This study is an open-label Phase 2 clinical trial evaluating the efficacy and safety of TYRA-300 at lower doses (50 and 60mg QD) in participants with FGFR3-altered low-grade, intermediate risk (IR) NMIBC. We expect to dose the first patient in this study in the second quarter of 2025.  

BEACH301 for ACH: This study is an open-label, Phase 2 dose-escalation/dose-expansion trial evaluating TYRA-300 at lower doses (0.125, 0.25, 0.375, 0.50 mg/kg) in children ages 3 to 10 with ACH with open growth plates. Prior to initiation of the first two cohorts, the study will enroll a safety sentinel cohort of up to 3 treatment-naïve participants per dose level in children ages 5 to 10. We expect to dose the first child in this study in the second quarter of 2025.

Our FGFR2 Program- TYRA-200 for Intrahepatic Cholangiocarcinoma

FGFR2 is a protein receptor present on the cell surface that promotes cellular proliferation and transformation upon binding of fibroblast growth factor. Activating gene alterations of FGFR2 have been implicated in the tumorigenesis of multiple solid tumor types, with pan-FGFR inhibitors approved for intrahepatic cholangiocarcinoma (ICC). 

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TYRA-200 is an FGFR1/2/3 inhibitor designed to be active against nearly all of the clinically identified acquired resistant mutations that arise during treatment with pan-FGFR inhibitors, which we believe is necessary to address the problem of disease progression due to polyclonal resistance. TYRA-200 is currently being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 that is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200, determine the optimal dose for further development and the MTD and RP2D, and evaluate preliminary antitumor activity, with a focus on achieving proof-of-concept in a cohort of FGFR2-driven