Protara Therapeutics Unveils Promising Phase 2 Data on TARA-002

Protara Therapeutics Showcases Interim Results from ADVANCED-2 Trial

NEW YORK, Protara Therapeutics, Inc. (NASDAQ: TARA), a company focused on developing transformative therapies for cancer and rare diseases, has recently announced exciting interim findings from its Phase 2 ADVANCED-2 trial. This trial investigates TARA-002 in patients suffering from non-muscle invasive bladder cancer (NMIBC). The data will be highlighted in a poster session at the upcoming annual meeting of the Society of Urologic Oncology (SUO) scheduled for early December.

Details of the ADVANCED-2 Trial

The ADVANCED-2 trial is an open-label Phase 2 study aimed at evaluating the efficacy and safety of TARA-002 for patients diagnosed with carcinoma in situ or CIS (± Ta/T1) who have been unresponsive to Bacillus Calmette-Guérin (BCG) therapy. Approximately 100 patients are expected to enroll in the BCG-unresponsive cohort alongside 27 BCG-naïve participants. The study complies with the FDA guidelines regarding the treatment of non-muscle invasive bladder cancer, making it potentially registrational for the unresponsive patient population.

Trial Administration

Enrolled subjects participate in a regimented treatment plan that includes initial intravesical instillations of TARA-002, followed by a maintenance schedule that aims to maximize therapeutic benefits. The interim analysis, which focuses on safety and efficacy, involved approximately 20 patients, revealing positive trends and initial safety profiles.

Poster Presentation Details

Details for the poster presentation are as follows:

• Title: ADVANCED-2: Phase 2 Open-Label Study to Evaluate Safety and Anti-Tumor Activity of Intravesical Instillation of TARA-002 in Adults with High-Grade Non-Muscle Invasive Bladder Cancer
• Poster Number: 119
• Poster Category: NMIBC
• Session Date: Thursday, December 5, 1:15 p.m. – 2:15 p.m. CT

Understanding TARA-002

TARA-002 is an investigational cell-based therapy developed for treating NMIBC and lymphatic malformations. It has been recognized by the U.S. FDA with a Rare Pediatric Disease Designation. Derived from a master cell bank of genetically unique Streptococcus pyogenes, TARA-002 is linked to OK-432, an established immunopotentiator marketed in Japan and Taiwan.

Mechanism of Action

Upon administration, TARA-002 is believed to activate innate and adaptive immune responses within the tumor environment, resulting in a pro-inflammatory response. This immune activation is accompanied by cytokine release, promoting an antitumor effect that includes direct cytotoxicity against cancer cells and subsequent immune engagement.

The Landscape of Non-Muscle Invasive Bladder Cancer

Bladder cancer ranks as the sixth most prevalent cancer type in the U.S., with NMIBC accounting for roughly 80% of all bladder cancer cases. Each year, an estimated 65,000 individuals receive a new NMIBC diagnosis, highlighting the urgent need for effective treatment options.

Protara's Commitment

Protara Therapeutics is dedicated to delivering innovative therapies designed to address the unmet medical needs of individuals with cancer and rare diseases. The ongoing development of TARA-002 exemplifies this commitment, as it focuses on improving outcomes for patients with challenging conditions. The company is also actively engaged in advancing other therapeutic candidates, including IV Choline Chloride, aimed at patients with nutritional deficiencies.

Frequently Asked Questions

What is TARA-002?

TARA-002 is an investigational cell therapy being developed by Protara Therapeutics for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations.

What are the key findings of the ADVANCED-2 trial?

The ADVANCED-2 trial has provided interim data suggesting positive safety and efficacy profiles for TARA-002 in patients with NMIBC, with more detailed results to be presented at the SUO meeting.

Where can I find more information about Protara Therapeutics?

You can find additional details about Protara and their programs on their official website at www.protaratx.com.

How does TARA-002 work?

TARA-002 is hypothesized to activate immune responses within tumors, producing inflammatory cytokines that contribute to direct tumor cell death and enhanced immune engagement.

How common is NMIBC?

Non-muscle invasive bladder cancer (NMIBC) represents approximately 80% of bladder cancer cases, with about 65,000 new diagnoses occurring in the United States each year.

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