Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 18

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 18
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 FGFR3 gene alterations.  As of March 2024, the Part A Phase 1 portion of SURF301 completed dose escalation up to 120mg without determining an MTD, and is currently evaluating doses below 120mg, including 100mg in preparation for initiating the Phase 2 portion of the study.

In October 2024, we announced interim clinical proof-of-concept data for TYRA-300 in patients with mUC from the SURF301 study. These data were presented in a late-breaking oral presentation at the 36th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain. As of the August 15, 2024 data cutoff, 41 patients were enrolled in the Phase 1 portion of the SURF301 Phase 1/2 study. Eligible participants were adults with advanced malignancies with or without FGFR3 alterations, including those previously treated with erdafitinib. The enrolled patient population was heavily pre-treated, with 44% of patients receiving ≥ 3 lines of therapy prior to receiving TYRA-300, and 76% of FGFR3+ mUC patients receiving ≥ 3 lines of therapy. Treatment with TYRA-300 was evaluated across six dose levels, ranging from 10 mg-120 mg QD. 

The study population was older and heavily pre-treated

8

In the preliminary PK/pharmacodynamics analysis in 41 patients as of the data cutoff, TYRA-300 plasma concentrations indicated adequate target coverage at ≥90 mg QD, with further PK characterization ongoing. 

Exposure at doses ≥90 mg exceeded FGFR3 IC90 target coverage

In patients with FGFR3+ mUC who received doses ≥ 90 mg QD, anti-tumor activity was observed in all patients: (i) 6 out of 11 (54.5%) patients at ≥ 90 mg QD achieved a confirmed PR, 3 of which are still ongoing; (ii) 5 out of 10 (50%) patients at 90 mg QD achieved a PR; (iii) 1 out of 1 (100%) patient at 120 mg QD achieved a PR; and (iv) a 100% disease control rate (DCR) was achieved for all patients at ≥ 90 mg QD (PR + stable disease). 

Anti-tumor activity was observed in all FGFR3+ mUC patients treated at  ≥90 mg QD

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