Tyra Biosciences Begins Phase 2 Trial of TYRA-300 for Bladder Cancer

Tyra Biosciences Initiates Phase 2 Trial for TYRA-300

Tyra Biosciences, Inc. has recently announced a significant milestone in its clinical research endeavors. The company has begun dosing the first patient in the Phase 2 SURF302 study, which aims to evaluate TYRA-300, an oral treatment for low-grade, intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). This clinical trial marks a pivotal moment for Tyra as it seeks to innovate and improve treatment options for patients grappling with this challenging condition.

Overview of TYRA-300

TYRA-300 is being developed as a first-in-class, FGFR3-selective inhibitor, specifically designed to minimize the toxic effects often associated with the inhibition of other fibroblast growth factor receptors, namely FGFR1, FGFR2, and FGFR4. This targeted approach is particularly relevant as alterations in the FGFR3 gene are prevalent among patients with IR NMIBC, with approximately 70% showing mutations that can lead to disease progression and recurrence.

Dr. Erik Goluboff, Senior Vice President of Clinical Development at Tyra, stated, "Our vision is to create a once-daily oral treatment not only to reduce the recurrence of the disease but also to diminish the need for invasive surgical interventions and intravesical therapies. We believe SURF302 will provide significant insights into improving patient outcomes."

Clinical Trial Details

The SURF302 study (NCT06995677) is an open-label Phase 2 clinical trial that aims to evaluate the safety and efficacy of TYRA-300 in patients with FGFR3 alterations in IR NMIBC. Up to 90 participants will be enrolled from multiple sites primarily across the United States.

Participants will be randomly allocated to receive either 50 mg or 60 mg of TYRA-300 once daily. The primary objective of the trial is to assess the complete response (CR) rate at three months, while secondary goals will explore factors such as time to recurrence and safety profiles.

Expert Opinions and Expectations

Dr. Tom Jayram, Director of the Advanced Therapeutics Center at Urology Associates, expressed enthusiasm about the trial's commencement, noting the complexities involved in treating IR NMIBC. "This condition poses a significant challenge due to its recurrence risks and the need for multiple procedures for surveillance. Selective FGFR inhibitors like TYRA-300 present a promising new therapeutic option that could personalize care for bladder cancer patients."

Addressing an Unmet Need

In the United States alone, over 730,000 individuals live with bladder cancer, many of whom suffer from intermediate-risk non-muscle invasive bladder cancer. Treatments typically involve surgical procedures alongside chemotherapy, which can severely impact a patient's quality of life.

TYRA-300 stands out as the only oral investigational agent targeting this category, aimed at providing better tolerated therapeutic options. The company plans to report initial complete response data in the first half of 2026, which will be crucial in gauging the treatment's potential.

Future Directions for TYRA-300

In addition to SURF302, TYRA-300 is being evaluated in other clinical settings, including a Phase 2 trial for pediatric achondroplasia known as BEACH301. This expansion reaffirms Tyra Biosciences' commitment to addressing diverse medical needs through innovative biotechnology solutions.

The potential for TYRA-300 to transform bladder cancer treatment protocols and enhance patient lives is significant. As the trial progresses, the medical community will be watching closely for results that could pave the way for a new standard of care in managing IR NMIBC.

For further information about Tyra Biosciences and its ongoing clinical trials, visit their official website.