Tyra Biosciences Gets FDA IND Clearance for Phase 2 of TYRA-300 in Bladder Cancer

Tyra Biosciences, Inc., a biotechnology firm specializing in the development of precision medicines targeting Fibroblast Growth Factor Receptor (FGFR) biology, has announced a significant milestone. The U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for TYRA-300. This approval paves the way for a Phase 2 clinical trial to evaluate TYRA-300 as a treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). The trial will be spearheaded by Dr. Erik Goluboff, who was recently appointed as Senior Vice President of Clinical Development at Tyra.

TYRA-300 is an oral, FGFR3-selective inhibitor designed to mitigate the toxic side effects commonly associated with the inhibition of FGFR1, FGFR2, and FGFR4. It holds promise for targeting FGFR3 mutations, which are present in 60-80% of IR NMIBC cases. The upcoming clinical evaluation includes three Phase 2 studies: SURF302 for IR NMIBC, BEACH301 for pediatric achondroplasia, and SURF301 for metastatic urothelial carcinoma (mUC).

The SURF302 trial will be an open-label study focusing on the efficacy and safety of TYRA-300 in participants with FGFR3-altered low-grade, IR NMIBC. It aims to enroll up to 90 participants across multiple sites, mainly in the United States. Participants will initially be randomized to receive either 50 mg or 60 mg doses of TYRA-300 daily. Depending on the outcomes of efficacy and safety evaluations, additional dosing cohorts may be considered. The primary objective is to determine the complete response rate at three months, while secondary objectives include assessing time to recurrence, median duration of response, recurrence-free survival, progression-free survival, safety, and tolerability.

Doug Warner, Chief Medical Officer of Tyra, emphasized the significance of the FDA approval, noting that it marks a crucial step forward for both the development of TYRA-300 and for patients with NMIBC, who are in need of more tolerable treatment options. The company plans to begin dosing patients in the second quarter, with initial three-month complete response data anticipated shortly thereafter.

Dr. Goluboff's extensive background in urologic oncology and clinical trial leadership makes him a valuable addition to Tyra. He previously served as Principal Medical Lead for genitourinary and gastrointestinal cancers at Genentech/Roche and has held senior roles at AstraZeneca. His academic tenure includes urology professorships at Columbia and Mount Sinai, along with managing thousands of patients with bladder, prostate, and kidney cancers.

Expressing enthusiasm about joining Tyra, Dr. Goluboff highlighted TYRA-300 as a leading candidate for treating IR NMIBC due to its proven mechanism of action and favorable tolerability compared to pan-FGFR inhibitors. He is eager to advance the SURF302 study and provide benefits to patients in need.

In the U.S., more than 730,000 individuals live with bladder cancer, many of whom suffer from IR NMIBC. The standard treatment involves transurethral resection of bladder tumors (TURBT) combined with intravesical chemotherapy, both of which can affect patients' quality of life. TYRA-300 represents a novel, orally administered investigational option for this condition.

TYRA-300 is Tyra's flagship precision medicine product, originating from its proprietary SNÅP platform. This investigational FGFR3-selective inhibitor is also being tested for other conditions, including metastatic urothelial cancer and skeletal dysplasia. In October 2024, Tyra reported promising interim clinical data for TYRA-300 in treating metastatic urothelial cancer. The company has received FDA clearance to proceed with the SURF302 trial for IR NMIBC and the BEACH301 trial for pediatric achondroplasia.

Tyra Biosciences, based in Carlsbad, California, leverages its SNÅP platform to develop targeted therapies for oncology and genetically defined conditions, focusing on addressing significant unmet medical needs.