Company: TYRA
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0000950170-25-046124
Chunk: 17

Company: Tyra Biosciences, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 17
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 at SUO 2023, 77% recurrence free survival (RFS) in high-risk papillary patients presented at ESMO 2023 and 73% 6-month CR rate in high-risk CIS patients presented at SUO 2023.  The safety and tolerability results were generally consistent with that known for erdafitinib, despite using a lower 6mg daily dose in these studies. TAR-210, an erdafitinib-containing 

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device implanted every three months via the urethra, also demonstrated a 90% CR rate in IR patients and 90% RFS in high-risk papillary patients as presented at AUA 2024. Johnson & Johnson has initiated a Phase 3 study for TAR-210 in low grade, IR patients and has not indicated plans to develop oral erdafitinib further in this setting.

Our solution, TYRA-300 in mUC and NMIBC

We believe an orally administered, highly specific FGFR3-directed inhibitor, with minimal effects from other FGFR-related toxicities, has the potential to be highly efficacious and tolerable and represents a potentially large future market opportunity for our product candidate in patients with FGFR3+ mUC and NMIBC. 

Designing inhibitors that bind to the ATP-binding site and that can selectively differentiate between FGFR3 and FGFR1 is challenging due to the near-identical amino acid sequence in this site. We utilized the differentiated approach of our SNÅP platform to generate compounds, including TYRA-300, that capitalize on subtle conformational differences between FGFR3 and FGFR1 to obtain greater than ten-fold selectivity for FGFR3 versus FGFR1. In comparison, other FGFR inhibitors that are approved or in clinical development such as erdafitinib, pemigatinib, futibatinib and infigratinib, have demonstrated low or no selectivity for FGFR3 over FGFR1 and FGFR2. 

Clinical development and data generated to date for TYRA-300 in oncology

In November 2022, we initiated our Phase 1 clinical trial of TYRA-300, SURF301, an international, multi-center, open label study designed to determine the optimal dose, MTD and the RP2D of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with locally advanced or mUC and other advanced solid tumors with