SAB Biotherapeutics Awarded Additional $60.5M from BARDA and U.S. Department of Defense for Rapid Response Capability and Advancing SAB-185 for Treatment of COVID-19 - Seite 2

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 U.S. 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. For more information on the Phase 2/3 trial, please visit clinicaltrials.gov (Identifier: NCT04518410). SAB-185 is also currently being evaluated in Phase 1 and Phase 1b studies, both of which have completed enrollment.

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.

About SAB-185

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 U.S. 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 (IgG) against the SARS-CoV-2 virus.

Direct support for the development of SAB-185 is provided by the US Department of Defense’s (DoD) 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 (DHA) 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.