Tyra Biosciences announced encouraging interim clinical proof-of-concept results for TYRA-300 in patients with metastatic urothelial cancer (mUC) from the SURF301 Phase 1/2 study. The data, presented at ENA 2024, demonstrated impressive anti-tumor activity at dose levels ≥ 90 mg once daily, with a generally well-tolerated safety profile.
TYRA-300 Shows Efficacy in mUC
The interim data from the SURF301 study revealed that 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a confirmed partial response (PR) at doses ≥ 90 mg once daily. The disease control rate was 100%, with sustained duration of activity. These findings support the continued development of TYRA-300 for mUC, with the company prioritizing once-daily dosing in ongoing and future oncology studies.
Todd Harris, CEO of TYRA, stated, "These data provide clinical support that an FGFR3 inhibitor designed to be highly selective can deliver meaningful clinical benefit to heavily pretreated patients with cancer." He added that the results allow the company to expand into larger studies for multiple bladder cancer indications, including mUC and non-muscle invasive bladder cancer (NMIBC).
Expansion into Achondroplasia and NMIBC
In October 2024, the FDA cleared Tyra's IND application for a Phase 2 clinical trial of TYRA-300 in children with achondroplasia (BEACH301). This multicenter, open-label, dose-escalation/dose-expansion study will evaluate TYRA-300 in children ages 3 to 10 with achondroplasia and open growth plates. The company expects to dose the first child in Q1 2025.
TYRA is also on track to submit an IND for a Phase 2 study of TYRA-300 in NMIBC before the end of 2024, aiming to address unmet needs in this cancer population with an efficacious, orally available therapy.
Advancing Other Pipeline Programs
The SURF201 Phase 1 study evaluating TYRA-200 in patients with FGFR2+ cholangiocarcinoma and other advanced solid tumors is ongoing. TYRA-200 is an investigational FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations.
Following IND clearance, TYRA is also planning a Phase 1 clinical study of TYRA-430, an investigational FGFR4/3-biased inhibitor for FGF19+/FGFR4-driven cancers, specifically advanced hepatocellular carcinoma (HCC) and other solid tumors with activating FGF/FGFR pathway aberrations.
Corporate Developments
In September 2024, Doug Warner, MD, was appointed as Chief Medical Officer (CMO). Dr. Warner brings over twenty years of clinical development leadership experience, having previously held roles at Amgen and eFFECTOR Therapeutics.
Financial Status
As of September 30, 2024, TYRA had cash, cash equivalents, and marketable securities of $360.1 million, which is expected to fund operations through at least 2026.
