SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a proprietary technology to produce fully human polyclonal antibodies without the need for human plasma donors, today announced in vitro data demonstrating that SAB-185, its COVID-19 therapeutic candidate, has highly-potent neutralizing antibodies to SARS-CoV-2 that are four times higher than the most potent human convalescent plasma serum sample evaluated. The company also announced that they initiated manufacturing of SAB-185 on May 25 to support the next phase of clinical development for its potential COVID-19 therapeutic, still on track to begin human trials in early summer.
“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.”
“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 U.S.,” 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.”
SAB’s novel approach, leveraging genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, higher potency neutralizing antibody product than has been previously possible. As a fully human polyclonal antibody, SAB’s novel therapeutic candidate for COVID-19 deploys the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies.
Data from SAB’s clinical trials in MERS coronavirus and other infectious disease targets have demonstrated the inherent optimal therapeutic properties of human polyclonal antibodies, including reduced immunogenicity and extended half-life, which point to the potential of this therapeutic approach for both treatment and prophylaxis.
“SAB Biotherapeutics has a successful preclinical track having developed more than a dozen effective antibodies from our DiversitAb™ platform in response to emerging infectious diseases during outbreaks of Ebola, Zika, Dengue, Hantavirus, and others,” said Sullivan. “A highly-potent, polyclonal antibody therapy for COVID-19, could prove critical in combatting this pandemic as it could potentially treat severely ill patients and provide protective antibodies for front-line responders, mission-critical staff, and high-risk populations, such as the elderly and immune compromised.”