#USA #Carlsbad #Tyra Biosciences #NMIBC #Dabogratinib

Tyra Biosciences Reports Initial Phase 2 SURF302 Results

Tyra Biosciences, a clinical-stage biotech firm, recently shared results from its Phase 2 study, SURF302, highlighting the effectiveness of oral dabogratinib, a potential frontrunner for treating low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC). This study aims to set the groundwork for what could be the first oral treatment option in this category.

The research indicates that approximately 70% of patients with LG IR NMIBC forego adjuvant therapies, mainly due to the cumbersome nature of existing treatments, which often involve repeated catheterizations and office visits for intravesical procedures. Tyra's objective is to offer a more convenient, once-daily oral medication that could alter the current treatment landscape.

“We are thrilled to announce these initial findings from SURF302 as we endeavor to introduce what may be the first once-daily oral option for patients battling low-grade IR NMIBC,” said Todd Harris, CEO of Tyra Biosciences. “The success of this study is attributed primarily to the patients and investigative teams involved, and we extend our thanks to all who contributed.”

The preliminary data demonstrated a robust efficacy profile with a 79% overall response rate (ORR) and a 64% complete response (CR) rate with the 60 mg dose. Notably, all patients with single marker lesions achieved an astounding 100% ORR, establishing a solid foundation for the upcoming Phase 3 trial. The initial safety reports were promising, showing minimal adverse effects, none of which included severe hyperphosphatemia, nail toxicity, or ocular complications.

The findings from SURF302 are pivotal not only for Taoya but also for the broader medical community, as highlighted by Dr. Mark Silva, a urologist who emphasized the challenge of treating patients who often opt for “watch and wait” strategies. A well-tolerated, once-daily oral treatment could significantly shift patients' perspectives, granting them a feasible option while allowing doctors to act proactively before any recurrence occurs.

The safety profile was notably reassuring across the study cohorts. The most frequent adverse effects observed were mild, with fatigue, diarrhea, and dry eyes being predominantly Grade 1 or 2, showcasing the drug's tolerability. No Grade 4 or 5 adverse events were reported, and treatment adherence remained high, with no significant dose reductions needed.

Results from the ongoing SURF303 study, which focuses on LG upper tract urothelial cancer (LG UTUC), also reflect the potential of dabogratinib, with the first patient achieving a complete response at the 3-month mark under the same dosing regimen.

Tyra plans to conduct a dose-optimizing study with a 70 mg cohort to explore higher doses for patients with multiple marker lesions, who tend to present larger tumor burdens. Developing dapobratinib further aligns with the company's goal to provide easily accessible and well-tolerated therapeutic options for bladder cancer patients.

Overall, Tyra's findings not only illustrate the promise of oral dabogratinib, but they also highlight the necessity for innovation in treating LG IR NMIBC, a field traditionally burdened by cumbersome procedures. As Tyra advances towards Phase 3 trailing, the medical community watches closely, eager to witness how this once-daily oral therapy could reshape patient care in bladder cancer.

For stakeholders interested in the ongoing developments, Tyra will host a conference call to discuss the results, ensuring transparency and continued engagement with investors and healthcare professionals alike.