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Protara Therapeutics Initiates Dosing of Initial Patient in Phase 1b/2 ADVANCED-2 Trial for TARA-002 Targeting NMIBC Patients with High-Grade Carcinoma in Situ

Thursday, September 21, 2023

Protara Therapeutics, Inc. (Nasdaq: TARA) has initiated dosing in its Phase 1b/2 ADVANCED-2 trial, which is examining the intravesical instillation of TARA-002, an experimental 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). Simultaneously, the ongoing ADVANCED-EXP trial, launched earlier this year, is progressing, with preliminary results anticipated in the first half of 2024.

Dr. Tom Jayram, Director of the Advanced Therapeutics Center at Urology Associates, P.C., TN, and a study investigator for the ADVANCED-2 trial, expressed optimism about the potential of TARA-002 as a new therapy for NMIBC patients, highlighting the need for innovative intravesical approaches for this condition.

The initiation of the ADVANCED-2 trial follows promising results from the ADVANCED-1 clinical trial of TARA-002 presented in April 2023, where it demonstrated good tolerability and anti-tumor activity, including tumor regression in CIS patients, including a complete response in a heavily pre-treated BCG-unresponsive patient.

Dr. Jathin Bandari, Chief Medical Officer of Protara Therapeutics, expressed optimism about TARA-002's potential to make a significant impact on the NMIBC treatment landscape and emphasized their commitment to advancing this trial alongside the ongoing ADVANCED-1EXP study.

The ADVANCED-2 trial (NCT05951179) is a Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with CIS (± Ta/T1) who are either BCG-naïve or BCG-unresponsive. Patients will receive an induction course of six weekly intravesical instillations of TARA-002, with or without a reinduction course, followed by a maintenance course in the BCG-unresponsive cohort.

The ongoing ADVANCED-1EXP trial is a Phase 1b open-label expansion trial assessing intravesical TARA-002 in 12 CIS patients, encompassing BCG-naïve, BCG-unresponsive, and BCG-inadequately treated patients.

TARA-002 is an investigational cell therapy developed for the treatment of NMIBC and LMs (Lipoblastoma-Myelomeningocele syndrome), holding Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA). It was developed using the same master cell bank as OK-432, a potent immunopotentiator marketed as Picibanil® in Japan and approved in Taiwan by Chugai Pharmaceutical Co., Ltd. TARA-002 activates innate and adaptive immune cells, leading to a strong immune response and the destruction of abnormal cells when administered.

Non-Muscle Invasive Bladder Cancer (NMIBC) constitutes approximately 80% of bladder cancer cases, with around 65,000 patients diagnosed annually in the United States. NMIBC refers to cancer found in the bladder's inner surface tissue that has not spread to the bladder muscle.

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