On May 15, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, reported positive updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC). These results in Bacillus Calmette-Guérin (BCG)-Naïve NMIBC patients will be featured today during a poster session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.

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"Today’s presentation demonstrates TARA-002’s impressive 12-month durability data and excellent safety profile for patients with BCG-Naïve NMIBC," said Mark Tyson, M.D., Professor of Urology, Mayo Clinic Phoenix, and ADVANCED-2 study investigator. "The NMIBC patient community faces a critical unmet need for safe, effective and bladder-sparing treatment options for this devastating disease. These compelling data, coupled with a simple, streamlined administration for both physicians and patients, make TARA-002 a potentially important new treatment option for BCG-Naïve high risk NMIBC patients."

"These data continue to support our conviction that TARA-002 has the potential to make a meaningful difference in the lives of patients with BCG-Naïve NMIBC," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "Notably, the durable 12-month complete response (CR) rate observed in the BCG-Naïve cohort continues to perform competitively among approved treatments and investigational therapies in development. We look forward to completing enrollment in the registrational BCG-Unresponsive cohort of ADVANCED-2 and initiating ADVANCED-3, a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-Naïve and potentially BCG-Exposed patients in the second half of 2026."

Updated Data Results in BCG-Naïve Patients

Efficacy

The BCG-Naïve dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5, 2026 data cutoff.

The CR rate at any time in BCG-Naïve patients was 72.4% (21 of 29).
The CR rate in BCG-Naïve patients was 66.7% (18 of 27) at six months and 55.0% (11 of 20) at 12 months.
Among responders:
The Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4).
91.7% (11 of 12) maintained their CR from nine to 12 months.
66.7% (4 of 6) of re-induced patients converted to a CR at six months.
Safety

The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria.

About ADVANCED-2

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 or BCG-Naïve. 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. Protara has completed enrollment of the BCG-Naïve cohort and expects to complete enrollment of the BCG-Unresponsive cohort in the second half of 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, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA. 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 the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and 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.

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.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. 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, MAY 15, 2026, View Source [SID1234665775])