Protara Therapeutics to Present New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients at the 26th Annual Meeting of the Society of Urologic Oncology

Core Insights - Protara Therapeutics, Inc. announced interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for treating non-muscle invasive bladder cancer (NMIBC) [1][2] - The trial data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology from December 2 to December 5, 2025 [1] - TARA-002 is an investigational cell therapy that has received Rare Pediatric Disease Designation from the FDA [3][6] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases [6] - The company's lead candidate, TARA-002, is being evaluated in ongoing Phase 2 trials for NMIBC and lymphatic malformations [6] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [6] Trial Details - The ADVANCED-2 trial includes BCG-Naïve patients with NMIBC, specifically those with carcinoma in situ or CIS [2] - The trial involves an induction course of six weekly intravesical instillations of TARA-002, followed by maintenance treatments [2] - The upcoming poster presentation will include updated safety and efficacy data from 31 enrolled patients [1][3] Disease Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases each year [5] - Bladder cancer is the sixth most common cancer in the United States [5] Mechanism of Action - TARA-002 is hypothesized to activate immune cells in the tumor, leading to a pro-inflammatory response and the release of cytokines [4] - The therapy aims to directly kill tumor cells and enhance the antitumor immune response through immunogenic cell death [4]