Protara Therapeutics Announces FDA Clearance of Investigational New Drug Application for TARA-002 for the Treatment of Non-Muscle Invasive Bladder Cancer

- Company Plans to Initiate Phase 1 Study of TARA-002 by Year-End -

- IND Application Included Submission of Confirmatory Large-Scale GMP Comparability Data -

NEW YORK, NY, USA I October 12, 2021 I Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). Protara expects to initiate a Phase 1 clinical trial of TARA-002 in adults with high-grade NMIBC by the end of 2021.

“We are thrilled to have reached this important milestone and look forward to quickly initiating our Phase 1 study in patients with NMIBC,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “There is an urgent need for new treatments for NMIBC. We are seeing significant increases in recurrence and disease progression, as well as an escalating number of patients requiring cystectomies. Supported by the strength of the existing clinical data in NMIBC for OK-432, the originator therapy for TARA-002, we believe this treatment represents a promising new option for NMIBC patients.”

The Phase 1 dose-finding, open-label trial will evaluate 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 maximum tolerated dose and recommended dose for a future Phase 2 clinical trial.

TARA-002 is manufactured from the same cell bank as OK-432, an approved therapy in Japan and Taiwan for multiple oncologic indications. In 2020, Protara successfully demonstrated initial manufacturing comparability between TARA-002 and OK-432. The confirmatory, GMP-scale comparability data for TARA-002 in relation to OK-432 have been completed and were reviewed by FDA as part of the clearance of the IND.

About TARA-002
TARA-002 is an investigational cell therapy in development for the treatment of non-muscle invasive bladder cancer and lymphatic malformations (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. Protara has successfully demonstrated 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-6, IL-8, IL-12, interferon-gamma (IFN-γ)-, tumor necrosis factor-alpha (TNF-α), and vascular endothelial growth factor (VEGF) 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.

About Protara Therapeutics, Inc.
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.

SOURCE: Protara Therapeutics

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