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Protara Therapeutics Provides Comparability and U.S. Regulatory Updates for TARA-002 Supporting Advancement in Oncology and Rare Disease Indications
- Company Demonstrates Initial Comparability Between TARA-002 and OK-432, Advancing to Final GMP Comparability Runs - - Reaches Alignment with FDA on
About this update from Protara Therapeutics, Inc.
[{"type":"text","content":"- Company Demonstrates Initial Comparability Between TARA-002 and OK-432, Advancing to Final GMP Comparability Runs -\n - Reaches Alignment with FDA on Development Path Forward for TARA-002 in Non-Muscle Invasive Bladder Cancer; Company Plans to Initiate Clinical Trials in 2021 - - Company Expects to Request Meeting with FDA by Year End to Discuss Path to BLA for TARA-002 in Lymphatic Malformations - NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, today announced its development plans for TARA-002 in both non-muscle invasive bladder cancer (NMIBC) and Lymphatic Malformations (LMs) following recent interactions with the U.S. Food and Drug Administration (FDA). TARA-002 is the Company’s lead investigational cell therapy based on the broad immunopotentiator OK-432, which is approved in Japan and Taiwan for the treatment of LMs and multiple oncologic indications. “The outcome of our recent interaction with the FDA represents a significant milestone for the TARA-002 program, confirming initial comparability between TARA-002 and OK-432 and expanding the potential market opportunity of TARA-002 beyond LMs to include a potentially significant oncology indication,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “Importantly, we believe that we have identified an efficient path forward that allows us to address the population of patients suffering from NMIBC who are lacking alternative therapeutic options. Patients suffering from NMIBC have limited approved treatment options, and with the current standard-of-care facing a historical long-term supply shortage, there is a dire need for novel and effective therapies for these patients.” Mr. Shefferman added, “In addition to the opportunity in NMIBC, as we near completion of our IND update and make progress toward finalizing GMP comparability of TARA-002 to OK-432, we continue to expect to request a meeting with the FDA by year end to discuss a potential near-term path to a BLA filing for TARA-002 in LMs. TARA-002 was recently granted a Rare Pediatric Disease Designation for LMs, a rare pediatric indication with an urgent need for new therapeutic approaches.” FDA Confirmed Initial Comparability...