9 July 2021 - - US-based biopharmaceutical company SAB Biotherapeutics has announced publication of in vitro data showing that SAB-185, the company's therapeutic candidate for the treatment of COVID-19 virus infections, demonstrated effective neutralization against SARS-CoV-2 virus strains containing the genetic substitutions present in recent variants of concern.

The article, "Human immunoglobulin from transchromosomic bovines hyperimmunized with SARS-CoV-2 spike antigen efficiently neutralizes viral variants," was published in the current edition of Human Vaccines and Immunotherapeutics.

SAB-185, a differentiated high-potency therapeutic candidate for COVID-19, is currently being assessed in a Phase 2/3 trial in non-hospitalized patients with mild-moderate COVID-19 infections.

It 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 (NIAID), part of the US National Institutes of Health.

In the study, researchers conducted SAB-185 neutralization assays with multiple mutant SARS-CoV-2 pseudovirus strains, including sequences present in recently mutated strains that have emerged as a global concern. SAB-185 retained its neutralization potency for variants of recent concern.

Importantly, compared to monoclonal antibodies and convalescent patient serum, where "escape mutants" are readily identified, escape mutants were not isolated after treatment with SAB-185.

Escape mutations are naturally occurring genetic mutations that allow viruses to evade both the host's natural immune response and anti-infective therapies.

SAB-185 is a fully-human, specifically targeted and broadly neutralizing polyclonal antibody therapeutic candidate in a Phase2/3 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 both the Munich, Washington and other variant strains in preclinical studies. Preclinical data has also demonstrated that SAB-185 is significantly more potent than human-derived convalescent immunoglobulin G.

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.

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 Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company advancing a new class of immunotherapies based on its 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 versatile and scalable DiversitAb platform is applicable to a wide range of serious unmet needs in human diseases. It rapidly produces natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale.

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