Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 23

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 23
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 from baseline in height z-score, proportionality and PK. We are also planning exploratory assessments of clinical outcomes such as functional improvements, changes in the spine, and quality of life measures. The Company expects to dose the first child with ACH in the BEACH301 study in the second quarter of 2025.

In July 2023 and January 2024, the FDA granted orphan drug designation and rare pediatric disease designation to TYRA-300, respectively, for the treatment of ACH.

Our FGFR2 Program

TYRA-200 for ICC

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. 

TYRA-200 is an investigational, oral, FGFR1/2/3 inhibitor designed to be active against activating FGFR2 gene alterations, as well as clinically important molecular brake and gatekeeper resistance mutations, and selective for FGFR4. We are focusing initial Phase 1 development of TYRA-200 in FGFR2-driven ICC resistant to treatment with prior FGFR inhibitors.  

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Disease background

ICC is a form of cancer that originates in the bile ducts, which are a series of thin vessels that transport bile from liver cells to the small intestine. The median OS for all patients diagnosed with ICC is reported to be 16.1 months. The median OS for patients diagnosed with late-stage disease is less than one year. Approximately 15-20% of patients with ICC have genetic alterations in FGFR2, which are primarily gene rearrangements and activating mutations. In addition to ICC, FGFR2 drives an estimated 7-16% of endometrial cancers and 0.8% of other solid tumors. 

ICC is a rare tumor, accounting for an estimated 10-20% of intrahepatic biliary cancers and an estimated ~11% of cancers of unknown primary origin. We estimate that in 2023, approximately 1,000 second-line FGFR2+ ICC patients are addressable for treatment with an FGFR2 inhibitor and approximately 500 FGFR2+ ICC patients are addressable in the FGFR-resistant setting in the United States. We also estimate that approximately 1,000 and 3,000 FGFR2+ patients with late-stage endometrial cancer and other solid tumors, respectively, may be addressable with FGFR