Protara Therapeutics Announces Trials in Progress Poster Presentation for the ADVANCED-1 Trial in NMIBC at the 2022 American Society of Clinical Oncology Annual Meeting
“There is a significant need for new treatment options for patients with NMIBC, one of the most recurrent and difficult to treat cancers,” said Jathin Bandari, M.D., Chief Medical Officer of Protara Therapeutics. “Based on its mechanism of action, and promising clinical data from its predecessor therapeutic OK-432, we believe that TARA-002 may address this pressing area of high unmet need. We look forward to continuing to advance this trial and exploring TARA-002’s full potential in NMIBC.”
Details of the poster presentation are as follows:
Title: A Phase 1a/b safety study of intravesical instillation of TARA-002 in adults with high-grade non-muscle invasive bladder cancer (ADVANCED-1)
Abstract Number: TPS4620
Session Title: Genitourinary Cancer—Kidney and Bladder
Session Date and Time: Saturday, June 4, 2022, from
Location: In-Person & Online |
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.
A copy of the abstract is available at https://meetings.asco.org.
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
Protara is committed to identifying and advancing transformative therapies for people with cancer and rare diseases with limited treatment options. Protara’s portfolio includes its lead program, TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer and lymphatic malformations, and IV Choline Chloride, an investigational phospholipid substrate replacement therapy for the treatment of intestinal failure-associated liver disease. For more information, visit www.protaratx.com.
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Source: Protara Therapeutics