On September 20, 2023 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that dosing is now underway in its Phase 1b/2 ADVANCED-2 trial evaluating intravesical instillation of TARA-002, the Company’s investigational cell-based therapy, for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) patients with Bacillus Calmette-Guérin (BCG)-naïve and BCG-unresponsive carcinoma in situ (CIS) (Press release, Protara Therapeutics, SEP 20, 2023, View Source [SID1234635283]). In addition, dosing is progressing in the ongoing ADVANCED-EXP trial started earlier this year with preliminary results expected in the first half of 2024.
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"The ADVANCED-2 trial in NMIBC is an exciting opportunity to build on the favorable anti-tumor and safety data of TARA-002 presented earlier this year," said Tom Jayram, M.D., Director, Advanced Therapeutics Center, Urology Associates, P.C., TN and study investigator for the ADVANCED-2 trial. "There is significant need for new intravesical approaches for NMIBC, which can recur and progress to invasive disease with current treatments. This trial looks at the potential clinical benefit of TARA-002 as a possible new therapy for NMIBC, across both BCG-naïve and BCG-unresponsive patient populations."
The initiation of this trial follows the positive results of the ADVANCED-1 clinical trial of TARA-002 presented in April 2023 at the American Urological Association Annual Meeting. In the dose-escalation component of that study, TARA-002 was generally well tolerated and anti-tumor activity was observed, including tumor regression in all three evaluable patients with CIS, including one heavily pre-treated BCG-unresponsive patient who achieved a complete response (CR).
"Following positive preliminary results from the ADVANCED-1 trial, we are pleased to have dosed the first patient in the ADVANCED-2 trial," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. "We believe TARA-002 has the potential to play a meaningful role in the NMIBC treatment landscape and look forward to progressing the trial in parallel with our ongoing ADVANCED-1EXP study."
ADVANCED-2 (NCT05951179) is a Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with CIS (± Ta/T1) who are BCG-naïve (N=27) and BCG-unresponsive (N=75). Trial subjects will receive an induction with or without a reinduction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly installations every three months in the BCG-unresponsive cohort.
The ongoing ADVANCED-1EXP trial is a Phase 1b open-label expansion trial evaluating intravesical TARA-002 in 12 CIS patients, including BCG-naïve, BCG-unresponsive, and BCG-inadequately treated patients.
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 and approved in Taiwan 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 strong immune cascade. Neutrophils, monocytes, and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha are secreted by immune cells to induce a strong inflammatory reaction and destroy the abnormal cells.
About Non-Muscle Invasive Bladder Cancer
Bladder cancer is the 6th 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.