On November 17, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming 26th Annual Meeting of the Society of Urologic Oncology (SUO) taking place from December 2, 2025 to December 5, 2025, in Phoenix, Arizona. The presentation will include data featured in the abstract published on the SUO website, as well as updated safety and efficacy data from 31 enrolled BCG-Naïve patients, the majority of whom have reached the six-month evaluation time point.
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ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive (n≈100) or BCG-Naïve (n=31). Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.
Details of the poster presentation are as follows:
Title: ADVANCED-2: Preliminary Efficacy and Safety Data in BCG-Naïve Participants with High-Grade Non-Muscle Invasive Bladder Cancer
Poster Number: 149
Poster Category: NMIBC
Session Title: Bladder Cancer
Session Date and Time: Thursday, December 4, 2025, 2:30 p.m. – 3:30 p.m. CT
About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.
When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.
About Non-Muscle Invasive Bladder Cancer (NMIBC)
Bladder cancer is the sixth most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.
(Press release, Protara Therapeutics, NOV 17, 2025, View Source [SID1234660026])