Benzinga | Jul 8, 2021 07:08AM EDT

Big Cypress Acquisition Corp. SPAC Merger Partner SAB Biotherapeutics Highlights Publication Of Preclinical Data Demonstrating SAB-185 Effectively Neutralizes SARS-CoV-2 Variants

Findings Published in Human Vaccines & Immunotherapeutics Show SAB-185 Neutralizes Virus Strains Containing Substitutions Present in Variants of Concern

SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibody therapeutics, today announced the 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 & 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 (NIH).

"These promising in vitro data show that SAB-185 can neutralize SARS-CoV-2 spike-containing viruses, including those with mutations present in some variants of concern and accordingly represents an encouraging potential treatment for COVID-19," said Sean Whelan, PhD, lead study investigator and Head of the Department of Molecular Microbiology, Washington University School of Medicine in St. Louis. "SAB-185 demonstrates effective neutralization of SARS-CoV-2 spike-containing viruses that have substitutions S477N, E484K, and N501Y, which have been implicated in COVID-19 outbreaks and surges in a number of countries and result in resistance to some antibodies."

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.

"This new study further reinforces our enthusiasm for the potential of SAB-185 as an effective, potent and highly-differentiated therapeutic for COVID-19, demonstrating its ability to neutralize virus strains containing variants that have been associated with more transmissible and severe disease," said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. "SAB-185 was developed using our novel DiversitAb(tm) platform, which produces fully-human polyclonal antibodies that work similarly to the natural way our bodies fight disease. We are continuing to assess the clinical efficacy of SAB-185 in collaboration with the U.S. government as COVID-19 variants threaten to undermine current vaccines and therapeutic monoclonal antibodies, highlighting the urgent global need for safe and effective treatments that are active against a broad range of COVID virus strains."