Date: 25-Aug-2020

SAB Biotherapeutics Announces SAB-185 To First Patient Treatment For COVID-19 In Phase 1b Clinical Trial

SAB Biotherapeutics, a clinical-stage biopharmaceutical company developing a novel immunotherapy platform for the production of targeted polyclonal antibodies, today announced the administration of SAB-185 to the first patient as part of its phase 1b clinical trial , which investigates the safety and pharmacological activity of this COVID-19 therapeutic agent. SAB-185 was developed on SAB's novel technology platform that leverages the natural human immune response to provide a differentiated, highly potent therapeutic option that potentially includes virus mutations. The drug is currently being tested as a treatment for COVID-19 as part of an ongoing Phase 1 study in healthy volunteers.

“We believe that SAB-185 has the potential to be tailored as a differentiated treatment option in an extremely specific way to the complexity, diversity and mutations of SARS-CoV-2. The gift to the first patient in this study marks an important milestone for us in the ongoing work on our solid COVID-19 program. This is a step forward in battling the ongoing global health crisis, ”said Eddie J. Sullivan, PhD, Co-Founder, President and CEO of SAB Biotherapeutics. "The pace at which we have progressed with our program shows our deep understanding of human polyclonal antibodies, the urgent need for treatment options, and our team's commitment to developing a novel group of immunotherapies, which can be used to create a responsive model for health crises. We look forward to continuing to advance our COVID-19 program and developing resources for rapid responses to new and emerging diseases. "

SAB-185 is a therapeutic agent with human polyclonal antibodies that can potentially neutralize the live virus SARS-CoV-2 at titers higher than in the plasma of convalescents. It was developed on SAB's proprietary DiversitAb ™ platform, which uses the natural human immune response to produce human polyclonal antibodies. SAB's novel approach, in which fully human antibodies are produced from genetically engineered cattle, enables the scalable, reliable production of targeted, highly potent neutralizing antibody products. With this approach, the rapid development of this novel immunotherapy for COVID-19 could be advanced. The same natural immune response is used to fight the disease that occurs in recovered patients,

The phase 1b clinical trial is a double-blind, randomized, increasing-dose study of SAB-185 administered intravenously to 21 patients with mild or moderate COVID-19. The primary endpoint of the study is safety. The secondary endpoints are an assessment of the course of mild or moderate COVID-19 in outpatients. Data from the phase 1 and phase 1b studies should form the basis for the dosage and design of subsequent phase 2 safety and efficacy studies. The Phase 1b study is envisaged to be conducted in multiple locations including Sanford Health in Sioux Falls, South Dakota.

"We are very excited to participate in this clinical study to research the safety of SAB-185 - a novel candidate for a therapeutic agent with human polyclonal antibodies against COVID-19, the first of its kind," said David A. Pearce, PhD, Head of Innovation and Research at Sanford Health.

"It is our goal to advance research on COVID-19 so that medical staff are better prepared in the future to treat people with this novel coronavirus," said Dr. Susan Hoover, Senior Researcher and Infectious Diseases Physician, Sanford Health. "This therapeutic agent would be a treatment in the early phase with which the situation of those treated by us could potentially be improved, so that they may not have to go to the clinic."

Direct support for the Phase 1 and 1b clinical trials of SAB-185 comes from the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) of the Joint Program for Chemical, Biological, Radiological and Nuclear Defense Department of Defense (DoD) on behalf of the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)).