Core Insights - Protara Therapeutics, Inc. is presenting findings from the ongoing Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) at the AUA 2025 Annual Meeting [1][2][3] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with TARA-002 as its lead candidate [10] - TARA-002 is an investigational cell therapy for NMIBC and lymphatic malformations (LMs), having received Rare Pediatric Disease Designation from the FDA [6][10] Trial Details - The ADVANCED-2 trial is assessing TARA-002 in NMIBC patients who are Bacillus Calmette-Guérin (BCG)-unresponsive or naïve, with approximately 100 patients in the BCG-unresponsive cohort and 30 in the BCG-naïve cohort [3] - The trial is designed to align with the FDA's guidance for developing treatments for BCG-unresponsive NMIBC [3] Presentation Information - Two presentations and a panel discussion on the ADVANCED-2 trial will occur at the AUA 2025 Annual Meeting from April 26 to April 29, 2025 [1] - The interim analysis abstract for the ADVANCED-2 trial is available on the AUA website, featuring updated safety and efficacy data [2] Mechanism of Action - TARA-002 is hypothesized to activate immune cells within the tumor, producing a pro-inflammatory response and releasing cytokines, while also directly killing tumor cells and inducing immunogenic cell death [8] Disease Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses, with around 65,000 new cases diagnosed annually in the United States [9]