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
NEW YORK, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (NASDAQ:TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated interim data from the cohort of BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 will be featured at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place from February 26, 2026 to February 28, 2026 in San Francisco.
The poster presentation will include updated safety and efficacy data from approximately 25 six-month evaluable BCG-Unresponsive NMIBC patients in the ongoing Phase 2 ADVANCED-2 trial.
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 (Cohort B N=75-100) or BCG-Naïve (Cohort A 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 presentations are as follows:
Title: ADVANCED-2: Interim efficacy and safety data in BCG-Unresponsive participants with high-grade non-muscle invasive bladder cancer
Poster Number: F15
Poster Track: Urothelial Carcinoma
Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Session Date and Time: Friday, February 27, 2026
In addition, interim safety and tolerability data from both BCG-Naïve and BCG-Unresponsive patients enrolled in ADVANCED-2 will also be presented.
Title: Interim safety and tolerability of TARA-002 in patients with BCG-Naïve and Unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2
Poster Number: H8
Poster Track: Urothelial Carcinoma
Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma
Session Date: Friday, February 27, 2026
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.
TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. 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
About Protara Therapeutics, Inc.
Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.
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Company Contact:
Justine O'Malley
Protara Therapeutics
[email protected]
646-817-2836
