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SAB Biotherapeutics Announces Progress on U.S. FDA’s Phased Review of Company’s Groundbreaking DiversitAb™ Platform
- FDA has approved five of seven sections in a rolling submission required for a New Animal Drug Application (NADA) for Company’s antibody generating
About this update from Sab Biotherapeutics, Inc.
[{"type":"text","content":"- FDA has approved five of seven sections in a rolling submission required for a New Animal Drug Application (NADA) for Company’s antibody generating DiversitAb™ platform in Transchromosomic (Tc) Bovine™ - Announcement further solidifies SAB leading position in delivering, fully-human high-potency target-specific multi-epitope binding immunoglobulin (hIgG) antibody treatments without the need for human donors SIOUX FALLS, S.D., May 09, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (SAB, Nasdaq: SABS), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted fully-human multi-epitope binding immunoglobulin (hIgG) antibodies, also known as fully-human polyclonal antibodies, without the need for human donors, today announced the U.S. Food and Drug Administration has approved five of seven sections required for the Company’s pending New Animal Drug Application (NADA) for the company’s antibody-generating platform in Transchromosomic (Tc) bovine. SAB is in the process of completing the remaining two sections of the NADA. Upon formal acceptance of the seven-step safety and effectiveness evaluation, the company will use this approval in support of Biologics License Applications (BLAs) with the FDA Center for Biologics Evaluation and Research (CBER) for its hIgG antibody investigational drugs. “SAB is the only company in the world progressing this kind of advanced genetic engineering to develop rapid, scalable production of highly potent, fully-human polyclonal IgG antibodies, without the need for human donors,” said Eddie J. Sullivan, Ph.D., co-founder, President, and Chief Executive Officer of SAB Biotherapeutics. “The FDA has an established regulatory pathway to review our cutting-edge science, and we are pleased to be making significant progress. This process is a one-time approval that will be applicable for all subsequent investigational products produced from the DiversitAb™ platform using our transchromosomic bovine. SAB is focused on a successful completion of NADA to rapidly pursue BLA approvals for our investigational therapeutics.” SAB continues to work closely with the FDA’s Center for Veterinary Medicine (CVM) and CBER to establish a NADA approval for the Company’s Tc bovine-based antibody-generating platform. In following this regulatory pathway, SAB’s proprietary p...