Investigational human polyclonal antibodies derived from genetically-engineered cattle reportedly neutralized SARS-CoV-2 four-times greater than convalescent plasma from humans and may be an effective therapeutic against current and mutating strains of the virus, biopharmaceutical company SAB Biotherapeutics says.
SAB-185 deploys the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies, according to SAB, which reports it is on-track to initiate clinical trials in early summer 2020.
SAB’s method of using genetically-engineered cattle to produce fully human antibodies without the need for human plasma donors enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible, the company says.
“These data indicate this human polyclonal antibody therapeutic has potent neutralizing activity against live SARS-CoV-2. The neutralizing titers of SAB-185 are significantly higher than those of the most potent plasma of recovered COVID-19 patients we’ve been able to source,” said William B. Klimstra, PhD Associate Professor of Microbiology and Molecular Genetics, Associate Professor of Immunology and Member of the Center for Vaccine Research at The University of Pittsburgh. “We are still in the early stages of evaluating SAB-185, but the preliminary results are promising. My laboratory is conducting a series of studies to bring SAB-185 into clinical trials as soon as possible.”
The company has initiated manufacturing of SAB-185 to support the next phase of clinical development for its potential COVID-19 therapeutic.
“In just seven weeks, we’ve accelerated development of a specifically targeted natural human polyclonal therapeutic, without the need for human serum, and generated large volumes of highly-potent neutralizing antibodies to SARS-CoV-2, to produce clinical lots of our COVID-19 therapeutic candidate, SAB-185,” said Eddie J. Sullivan, PhD, President, CEO and Co-founder of SAB Biotherapeutics.
“Consistent with data across SAB’s platform in other indications, these data suggest that our potential COVID-19 therapeutic may remain effective even as SARS-CoV-2 continues to evolve. SAB-185, which was developed from the original Wuhan strain sequences, demonstrated highly-potent neutralizing titers to the mutated Munich strain of the virus, believed to be most prevalent strain in the US,” added Sullivan. “These data give us great confidence as we begin manufacturing clinical product and prepare to move forward in the regulatory pathway to provide a potential solution to combat COVID-19.”