FDA findings from research published in bioRxiv using in vitro pseudovirus models confirm SAB-185 broadly neutralizes variants of concern

SAB-185 currently being evaluated in NIH-sponsored Phase 2/3 adaptive trial

SIOUX FALLS, SD, USA I August 11, 2021 I SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibody therapeutics without the need for human donors, today announced the publication of data showing that SAB-185, the company’s therapeutic candidate for the treatment of COVID-19 infections, demonstrates effective and potent neutralization of multiple SARS-CoV-2 variants of concern, including the Delta and Lambda variants. The nonclinical study, Fully Human Antibody Immunoglobulin from Transchromosomic Bovines is Potent Against SARS-CoV-2 Variant Pseudoviruses, was conducted by scientists at the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) and published in bioRxiv, the online life sciences archive for COVID-19 SARS-CoV-2 preprints.

SAB-185 is a fully-human, specifically targeted and broadly neutralizing polyclonal antibody therapeutic candidate. It 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 (NIH).

“These encouraging data come at a critical time, as the Delta variant is causing a surge of COVID-19 infections around the globe and public health experts are voicing concerns about emerging new variants such as Lambda and others yet to be identified,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. “These in vitro data demonstrating the efficacy of SAB-185 against the Delta and Lambda variants were produced to provide new insights into antibody binding to the SARS-CoV-2 spike variants, and as a result further bolster our confidence that SAB-185 has the potential to provide neutralization of current and future mutant SARS-CoV-2 strains. We look forward to working with our US government collaborators to advance our COVID-19 program, with the goal of making SAB-185 available to patients as soon as possible once its clinical utility is confirmed.”

In the study, researchers evaluated SAB-185 using a lentiviral-based pseudovirus assay conducted in a BSL2 environment that incorporates a stable 293T cell line expressing human angiotensin converting enzyme 2 (ACE2) and transmembrane serine protease 2 (TMPRSS2). The results indicate that SAB-185 retained potency to neutralize recombinant S protein lentiviral pseudoviruses that mimic SARS-CoV-2 Delta (B. 1.617.2), Kappa (B.1.617.1) and Lambda (C.37) variants.

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 polyclonal antibody therapeutic in a Phase 2/3 adaptive trial for the treatment of COVID-19. It was developed in collaboration with the US government using SAB’s novel proprietary DiversitAb™ Rapid Response Antibody Program. In preclinical studies, the novel therapeutic has shown potent neutralization of the Munich, Washington and other variant strains, including Delta and Lambda. Preclinical data has also indicated that SAB-185 is significantly more potent than human-derived convalescent immunoglobulin G (IgG).

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 Department of Health and Human Services (DHHS) Office of the Assistant Secretary for Preparedness and Response, under contract #MCDC 2019-448.

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. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) 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 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. For more information on SAB, visit: http://www.sabbiotherapeutics.com and follow @SABBantibody on Twitter.

SOURCE: SAB Biotherapeutics