Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 19

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 19
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RA-300 demonstrated favorable interim safety results as of the data cutoff date: (i) preliminary data has shown TYRA-300 was generally well-tolerated, with infrequent FGFR2- and FGFR1-associated toxicities; (ii) in doses from 10 mg up to 120 mg QD, there were 4 (10%) serious adverse events related to TYRA-300, 1 DLT of grade (Gr) 3 diarrhea at 90 mg QD, and 1 TRAE leading to discontinuation of treatment (Gr3 ALT, 90 mg QD); (iii) there were no ≥ Gr4 TRAEs; and (iv) the 120 mg QD dose was the highest dose evaluated with no DLTs reported.

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At 90mg QD, improved tolerability was observed with TYRA-300 as compared to erdafitinib

At dose levels lower than 60mg, including target dose levels for NMIBC and skeletal conditions, TYRA-300 exhibited favorable interim safety results as of the data cutoff date. No hyperphosphatemia, discontinuation or dose reductions were reported at doses equal to or below 60mg.

FGFR-related toxicities were infrequent at lower doses

Future clinical development plans for TYRA-300 in mUC and NMIBC

We believe that the full development potential for TYRA-300 may cover the entire spectrum of disease in UC, and may represent a large opportunity relative to other drug targets given the high prevalence of FGFR3 mutations and the potential to treat earlier disease.

The Phase 2 portion of SURF301 will test two doses of TYRA-300. We plan to include cohorts of mUC patients naïve to FGFR inhibitors as well as a small cohort of mUC patients who have received an FGFR inhibitor 

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previously and have developed resistance to that inhibitor due to an FGFR3 mutation, such as the gatekeeper V555M.

In January 2025, we announced that the FDA cleared our Investigational New Drug application (IND) for TYRA-300 to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, IR NMIBC (SURF302). SURF302 will be an open-label Phase 2 clinical study evaluating the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC.  The study will enroll up to 90 participants at multiple sites primarily in the United States