Core Insights - Protara Therapeutics, Inc. is set to present updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) at the ASCO Genitourinary Cancers Symposium in February 2026 [1][4] 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 for NMIBC and lymphatic malformations [8] - TARA-002 is an investigational cell therapy derived from genetically distinct group A Streptococcus pyogenes, which has been granted Rare Pediatric Disease Designation by the FDA [5][8] Clinical Trial Details - The ADVANCED-2 trial (NCT05951179) is an open-label Phase 2 study assessing TARA-002 in NMIBC patients, specifically those who are BCG-Unresponsive or BCG-Naïve [3] - Approximately 25 patients will be evaluated for updated safety and efficacy data in the upcoming presentation [2] - The trial includes an induction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course [3] Presentation Information - The poster presentation titled "ADVANCED-2: Interim efficacy and safety data in BCG-Unresponsive participants with high-grade non-muscle invasive bladder cancer" will take place on February 27, 2026 [4] - Another poster titled "Interim safety and tolerability of TARA-002 in patients with BCG-Naïve and Unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2" will also be presented on the same day [5] Mechanism of Action - TARA-002 acts as a first-in-class TLR2/NOD2 agonist, activating both innate and adaptive immune pathways within the bladder wall, leading to a pro-inflammatory response and direct tumor cell death [6] Market Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases diagnosed annually [8]
Protara Therapeutics to Present Updated Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Unresponsive NMIBC Patients at the ASCO Genitourinary Cancers Symposium