On December 1, 2022 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported that it will present a Trials in Progress poster related to its ADVANCED-1 Phase 1 trial at the Annual Meeting of the Society of Urologic Oncology being held in San Diego, California from November 30, 2022 through December 2, 2022 (Press release, Protara Therapeutics, DEC 1, 2022, View Source [SID1234624690]). The ADVANCED-1 study is evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC).

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"This large addressable patient population is underserved by current treatment options which drives significant unmet need in NMIBC, and leaves room for creative therapeutic approaches such as TARA-002," said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. "Based on TARA-002’s immune-potentiating mechanism of action and supportive clinical data from its predecessor compound OK-432 in multiple solid tumors, we are excited to continue our ongoing ADVANCED-1 trial exploring TARA-002 in NMIBC and look forward to expanding our clinical development program."

Details of the poster presentation are as follows:

Title: Phase 1a/b Safety Study of Intravesical Instillation of TARA-002 in Adults with High-grade Non-muscle Invasive Bladder Cancer (ADVANCED-1)
Poster Number: 191
Poster Category: Bladder 4 (Bladder Cancer > Non-Muscle Invasive Bladder Cancer)
Session Title: E-Poster Displays
Session Date and Time: Friday, December 2 at 9:00 a.m. – 10:00 a.m.
Location: Sapphire ABEFIJMN, Hilton San Diego Bayfront, San Diego, California

ADVANCED-1 is a Phase 1 dose-finding, open-label trial (NCT05085977 and NCT05085990) evaluating TARA-002 in treatment-naïve and treatment-experienced NMIBC patients with high-grade carcinoma in situ (CIS) and high-grade papillary tumors (Ta). In the initial dose escalation phase of the trial, patients will receive six weekly intravesical doses of TARA-002. The primary objective of the trial is to evaluate the safety, tolerability and preliminary signs of anti-tumor activity of TARA-002, with the goal of establishing a recommended dose for a planned Phase 2 clinical trial.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and 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 Taiwan by Chugai Pharmaceutical Co., Ltd.

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, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and granulocyte-macrophage colony-stimulating factor, are secreted by immune cells to induce a strong local 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.