November 30, 2020 07:45 AM EASTERN STANDARD TIME
SIOUX FALLS, S.D.–(BUSINESS WIRE)–SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce specifically targeted, high-potency, fully human polyclonal antibodies without the need for human serum, today announced that, as part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) have awarded SAB $57.5 million in expanded scope for its DiversitAb™ Rapid Response Antibody Program contract for the manufacturing of SAB-185, the company’s clinical-stage therapeutic candidate for COVID-19.
“We are pleased to be awarded this additional contract scope, which we believe is a reflection of the compelling science that supports SAB-185’s potential in COVID-19, as well as the urgent need for treatment options amidst the global pandemic. Previous data has indicated that this human polyclonal antibody therapeutic has potent neutralizing activity against SARS-CoV-2, potentially driving more available doses, giving us the confidence to continue to progress our clinical development programs for SAB-185,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. “This manufacturing agreement with BARDA and the Department of Defense supports our vision of bringing a novel, first-of-its-kind human polyclonal antibody therapeutic candidate for COVID-19 to patients, and I am proud of the work by our team and appreciate the continued support from BARDA and JPEO as we continue to rapidly advance SAB-185.”
SAB-185 is currently being tested as a COVID-19 therapeutic in an ongoing Phase 1 trial in healthy volunteers and an ongoing Phase Ib trial in patients with mild or moderate COVID-19. SAB has leveraged its expertise to develop scalable manufacturing capabilities to support clinical activities, and continues to increase capacities in working with contract manufacturing organizations.
SAB-185 is a fully-human, specifically-targeted and broadly neutralizing polyclonal antibody therapeutic candidate for COVID-19. The therapeutic was developed from SAB’s novel proprietary DiversitAb™ Rapid Response Antibody Program. SAB filed the Investigational New Drug (IND) application and produced the initial clinical doses in just 98 days from program initiation. The novel therapeutic has shown neutralization of both the Munich and Washington strains of mutated virus in preclinical studies. Preclinical data has also demonstrated SAB-185 to be significantly more potent than human-derived convalescent plasma.
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed the only platform that can rapidly produce natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale. SAB-185, a fully-human polyclonal antibody therapeutic candidate for COVID-19, is being developed with initial funding supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services and the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB). In addition to COVID-19, the company’s pipeline also includes programs in Type 1 diabetes, organ transplant and influenza. For more information visit: www.sab.bio or follow @SABBantibody on Twitter.