Therapy Areas: AIDS & HIV
SAB Biotherapeutics Awarded Additional USD 60.5m from BARDA and US Department of Defense for Rapid Response Capability and Advancing SAB-185 for Treatment of COVID-19
22 September 2021 - - The US Department of Defense has awarded US-based biopharmaceutical company SAB Biotherapeutics an additional USD 60.5m in expanded scope for its DiversitAb Rapid Response Antibody Program for advanced clinical development through licensure and commercial manufacturing for SAB-185, the company's therapeutic candidate for the treatment of COVID-19, the company said.

The new award expands the scope of SAB's existing DiversitAb Rapid Response Antibody Program contract with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (CBRND), Joint Project Lead CBRND Enabling Biotechnologies (JPL-CBRND-EB).

SAB has announced four awards currently totaling more than USD 200m since March of 2020, including funding from the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant secretary for Preparedness and Response at the US Department of Health and Human Services, Office of the Assistant secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency.

SAB-185, a fully-human, high-potency polyclonal antibody therapeutic candidate for the treatment of COVID-19 infections, is advancing as part of the Countermeasures Acceleration Group, formerly Operation Warp Speed.

It is currently being assessed in a Phase 2/3 trial in non-hospitalized patients with mild-moderate COVID-19 infections at risk for disease progression.

The Phase 2 portion of the trial recently completed full patient enrollment.

SAB-185 is the first polyclonal antibody therapeutic included in the ACTIV-2 master protocol, a study sponsored, funded and conducted by the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

The Phase 2/3 trial is a randomized, double-blind, adaptive study that is assessing the clinical safety and efficacy of SAB-185 in addition to standard of care. SAB-185 is administered intravenously and is being evaluated in high- and low-dose arms.

Multiple primary endpoints being assessed include duration of COVID-19 symptoms and quantification of viral load on multiple timepoints through day 28.

On June 22, 2021, SAB announced a planned merger with Big Cypress acquisition Corp. (NASDAQ: BCYP). The transaction is expected to close in the fourth quarter of 2021.

SAB-185 is a fully-human, specifically targeted and broadly neutralizing polyclonal antibody therapeutic candidate in a Phase 2/3 adaptive trial for COVID-19.

The therapeutic was developed from SAB's novel proprietary DiversitAb Rapid Response Antibody Program in collaboration with the US government.

The novel therapeutic, generated from a subunit of the SARS-CoV-2 Wuhan strain, has shown neutralization of the Munich, Washington, Delta, Lambda and other variant strains in nonclinical studies.

Preclinical data has also demonstrated that SAB-185 is significantly more potent than human-derived convalescent immunoglobulin G against the SARS-CoV-2 virus.

Direct support for the development of SAB-185 is provided by the US Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) on behalf of the Office of the Assistant secretary of Defense for Health Affairs (OASD(HA)) and the Defense Health Agency and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant secretary for Preparedness and Response, under contract #MCDC 2019-448.

NIH's Accelerating COVID-19 Therapeutic Inventions and Vaccines (ACTIV) is a public-private partnership to develop a coordinated research strategy to speed up the development of the most promising treatments and vaccine candidates for COVID-19 and has five adaptive master protocols for ACTIV clinical trials.

ACTIV-2 is a master protocol designed for evaluating multiple investigational agents compared to placebo in adults with mild-to-moderate COVID-19 not requiring hospitalization.

The Rapid Response Antibody Program was initiated as a USD 27m progressive and competitive three-stage contract awarded by the DoD.

The contract called for the development of a 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 to address known and novel emerging biodefense (viral, bacterial or toxin) threats.

Stage 4, "COVID-19 Pandemic Response," was awarded in April of 2020 with up to USD 9.4m in support from Biomedical Advanced Research and Development Authority (BARDA).

The current additional award of USD 60.6m, brings the total to USD 200m.

SAB Biotherapeutics is a clinical-stage, biopharmaceutical company advancing a new class of immunotherapies leveraging fully human polyclonal antibodies.

SAB has applied advanced genetic engineering and antibody science to develop transchromosomic Bovine herds that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer.

SAB's DiversitAb platform is applicable to a wide range of serious unmet needs in human diseases.

It produces natural, specifically targeted, high-potency, human polyclonal immunotherapies.

SAB is currently advancing multiple clinical programs and has a number of collaborations with the US government and global pharmaceutical companies.


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