Protara Therapeutics to Present Phase 2 TARA-002 Data for BCG-Naïve Bladder Cancer Patients at SUO Meeting
核心洞察
Protara Therapeutics will present interim data from 31 BCG-naïve non-muscle invasive bladder cancer patients treated with TARA-002 at the Society of Urologic Oncology meeting in December 2025.
The Phase 2 ADVANCED-2 trial evaluates intravesical TARA-002 in patients with carcinoma in situ, with the majority of enrolled patients having reached the six-month evaluation timepoint.
TARA-002 is an investigational cell therapy derived from Streptococcus pyogenes that activates immune responses and directly kills tumor cells through immunogenic cell death.
Protara Therapeutics announced that interim data from its Phase 2 ADVANCED-2 trial evaluating TARA-002 in BCG-naïve non-muscle invasive bladder cancer (NMIBC) patients will be presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in Phoenix, Arizona, from December 2-5, 2025.
The presentation will feature updated safety and efficacy data from 31 enrolled BCG-naïve patients in Cohort A of the ongoing Phase 2 open-label trial, with the majority having reached the six-month evaluation timepoint. The data will be presented during a poster session on Thursday, December 4, 2025, from 2:30-3:30 p.m. CT.
Trial Design and Patient Population
The ADVANCED-2 trial (NCT05951179) is evaluating intravesical TARA-002 in NMIBC patients with carcinoma in situ (CIS ± Ta/T1) across two cohorts: BCG-Unresponsive patients (approximately 100 participants) and BCG-naïve patients (31 participants). Trial subjects receive an induction course of six weekly intravesical instillations of TARA-002, with or without reinduction, followed by a maintenance course of three weekly instillations every three months.
TARA-002 Mechanism of Action
TARA-002 is an investigational cell therapy 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 demonstrated manufacturing comparability between TARA-002 and OK-432.
The therapy works through multiple mechanisms when administered. It activates innate and adaptive immune cells within the tumor, producing a pro-inflammatory response with release of cytokines including tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10, and IL-12 (搜索). Additionally, TARA-002 directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.
Clinical Context
Bladder cancer ranks as 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 annually in the United States. NMIBC is characterized as cancer found in the tissue lining the inner surface of the bladder that has not spread into the bladder muscle.
TARA-002 has received Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for the treatment of lymphatic malformations (LMs), in addition to its development for NMIBC treatment.