#United States #Carlsbad #Tyra Biosciences #TYRA-300 #Bladder Cancer

Tyra Biosciences Advances to Phase 2 Trials with TYRA-300

Tyra Biosciences, Inc., a clinical-stage biotechnology firm focused on developing advanced precision medicines, announced a significant milestone in the battle against non-muscle invasive bladder cancer (NMIBC). The company has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Investigational New Drug (IND) application for TYRA-300. This will enable Tyra to initiate a Phase 2 clinical trial that primarily targets intermediate-risk NMIBC (IR NMIBC).

Leadership and Strategy

The new Phase 2 study named SURF302 will be managed by Dr. Erik Goluboff, who has recently joined Tyra as Senior Vice President of Clinical Development. Dr. Goluboff brings over 30 years of expertise in urologic oncology which includes roles such as the Principal Medical Lead for Genentech/Roche's GU/GI cancers. His impressive track record encompasses leading numerous clinical trials and managing patients with various types of cancer, including bladder cancer.

In this upcoming study, TYRA-300 aims to provide more tolerable treatment options for patients burdened by the side effects of standard therapies. Its unique design focuses on selectively inhibiting FGFR3 without affecting other FGFR variants that might lead to adverse effects. Given that FGFR3 represents the most commonly altered gene in NMIBC, with alterations appearing in 60-80% of cases, TYRA-300's potential is promising.

Trial Details

The Phase 2 study will be an open-label trial and is expected to enroll up to 90 participants across multiple clinical sites predominantly located in the United States. Patients will initially be grouped into two cohorts: one receiving TYRA-300 at a dosage of 50 mg once daily and another receiving 60 mg. The primary measure of success for the trial will be the complete response rate observed at the three-month mark, while secondary objectives will assess various factors such as recurrence rates and treatment safety.

Doug Warner, Chief Medical Officer of Tyra, emphasized the urgency of this research, stating that this clearance is a vital advancement for both the drug and for patients who need improved treatment options for NMIBC.

About Bladder Cancer

Bladder cancer significantly impacts the lives of many individuals, with over 730,000 diagnosed cases in the United States alone. Within this group, many have IR NMIBC and regularly experience recurrence, necessitating ongoing treatment. The current standard of care involves a surgical procedure combined with chemotherapy, which can seriously affect patients' well-being and quality of life. These challenges underscore the critical need for new therapeutic avenues like TYRA-300.

Future Outlook

As Tyra prepares for the dosing of its first patient in SURF302 in the second quarter of this year, both the company and the medical community remain optimistic about the results. The ultimate aim is to provide an effective and better-tolerated alternative to existing treatments, enhancing outcomes for patients battling bladder cancer. With the backing of Dr. Goluboff's expertise and the innovative capabilities of Tyra's SNÅP platform, the company is well-positioned to push forward its lead candidate in the competitive landscape of oncology.

TYRA-300's development also extends to conditions beyond bladder cancer. It is in evaluation phases for achondroplasia and metastatic urothelial carcinoma, further highlighting Tyra Biosciences' dedication to advancing precision medicine across different patient populations.

For more information regarding Tyra's innovative approaches, visit Tyra Biosciences and join the conversation on LinkedIn.