Funds clinical development and manufacturing of SAB-185, a therapeutic candidate for COVID-19, as well as increased production capacity for rapid response
JPEO-CBRND is also providing additional direct funding for first-in-human clinical studies in continued collaboration with BARDA, which remain on track
SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human donors, announced today that it has been awarded an additional $35.6 million in expanded scope for its DiversitAb™ Rapid Response Antibody Program contract from the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO - CBRND) Joint Project Lead for Chemical, Biological, Radiological and Nuclear Defense Enabling Biotechnologies (JPL CBRND EB). With this latest follow-on award, executed by JPEO-CBRND in coordination with the Office of the Assistant Secretary of Dense for Health Affairs (OASD(HA)) and the Defense Health Agency (DHA), SAB has announced three awards currently totaling $72 million for its rapid response capability and development of its COVID-19 therapeutic candidate, SAB-185, since March of 2020. Previous awards were supported by JPL CBRND EB and 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 (HHS).
"Our team is urgently and diligently executing on development and scaling to respond to the current coronavirus pandemic. We filed the Investigational New Drug (IND) application for SAB-185 in just 98 days from the initiation of the program," said Eddie J. Sullivan, co-founder, president and CEO of SAB Biotherapeutics. "We appreciate the continued confidence and collaboration with JPL CBRND EB and BARDA as we work together to rapidly advance our therapeutic candidate for COVID-19, strengthen our capabilities, and build our capacities to be responsive to future emerging threats with safe and effective human polyclonal antibody therapies."
The expanded scope provides additional funding for clinical development and manufacturing for SAB-185, a new therapeutic targeted to SARS-CoV-2 without using human donors. Separate from the funding award, JPEO-CBRND in coordination with OASD (HA) and DHA, is providing direct funding for the first-in-human clinical trials, poised to begin this month. In addition, the expanded scope aims to build rapid response capacity and capabilities for current and future product development from discovery through licensure.
About the DiversitAb™ Rapid Response Antibody Program:
The Rapid Response Antibody Program was initiated as a $27 million progressive and competitive three-stage rapid response contract awarded by the U.S. Department of Defense (DoD). The contract called for the development of a state-of-the-art, pharmaceutical platform technology capable of rapidly and reliably producing antibody-based medical countermeasures for biological threats to accelerate the delivery of a series of potent, fully-human, antibody therapeutics. Stage 4, "COVID-19 Pandemic Response," was awarded in April of 2020 with up to $9.4 million in support from Biomedical Advanced Research and Development Authority (BARDA). The current additional award of $35.6 million, brings the total to up to $72 million.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus or follow JPEO-CBRND on social media at @JPEOCBRND.
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, highly-targeted, high-potency, human polyclonal immunotherapies at commercial scale. The company is advancing programs in autoimmunity, infectious diseases, inflammation and oncology. SAB is rapidly progressing on a new therapeutic for COVID-19, SAB-185, fully human polyclonal antibodies targeted to SARS-CoV-2 without using human donors.