Phase 1b clinical trial will evaluate the safety and pharmacological activity of SAB-185 in COVID-19 patients
Second study initiated this month testing SAB-185 for the treatment of COVID-19
August 21, 2020 09:37 AM Eastern Daylight Time
SIOUX FALLS, S.D.–(BUSINESS WIRE)–SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce targeted polyclonal antibodies, today announced the dosing of the first patient in its Phase 1b clinical trial evaluating the safety and pharmacological activity of SAB-185, a COVID-19 therapeutic. SAB-185, developed from SAB’s novel technology platform that leverages the native human immune response to offer a differentiated high-potency therapeutic option that potentially addresses virus mutations, is currently being tested in an ongoing Phase 1 trial in healthy volunteers for the treatment of COVID-19.
“We believe that SAB-185 has the potential to be a differentiated treatment option that provides a highly-specific match against the complexity, diversity, and mutations of SARS-CoV-2. Dosing the first patient in this study marks a major milestone for us as we continue to advance our robust COVID-19 program and represents a step forward in the fight against the ongoing global health crisis,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. “The speed with which we have advanced our program reflects our deep understanding of human polyclonal antibodies, the pressing need for treatment options, and the commitment of our team to develop a novel class of immunotherapies that is designed to establish a responsive model for health crises. We look forward to continuing to progress our COVID-19 program, and developing rapid response capabilities to new and emerging diseases.”
SAB-185, a human polyclonal antibody therapeutic that potently neutralizes live SARS-CoV-2 at titers higher than convalescent plasma, was developed from SAB’s proprietary DiversitAb™ platform, which harnesses the native human immune response to produce human polyclonal antibodies. SAB’s novel approach, which leverages genetically engineered cattle to produce fully human antibodies, enables a scalable and reliable production of targeted, high potency neutralizing antibody product. This approach has expedited the rapid development of this novel immunotherapy for COVID-19 deploying the same natural immune response to fight the disease as recovered patients, but with a much higher concentration of targeted antibodies.
The Phase 1b clinical trial is a randomized, double-blind, ascending dose study of SAB-185 administered intravenously in 21 patients with mild or moderate COVID-19. The primary endpoint of the study is safety. The secondary endpoints include an evaluation of the course of mild and moderate COVID-19 in ambulatory patients. Data from both the Phase 1 and Phase 1b studies will be used to inform the dosing and design of subsequent Phase 2 safety and efficacy studies. The Phase 1b trial is planned to be conducted at multiple sites including Sanford Health in Sioux Falls, South Dakota.
“We are excited to participate in this clinical trial to investigate the safety of SAB-185, a novel, first-of-its-kind human polyclonal antibody therapeutic candidate for COVID-19,” said David A. Pearce, PhD, president of innovation and research at Sanford Health.
“Our goal is to advance the science around COVID-19 so physicians can be better prepared to treat this novel coronavirus in the future,” said Dr. Susan Hoover, principal investigator and an infectious disease physician at Sanford Health. “This therapeutic would be an early-stage treatment that could potentially improve our patients’ outcomes and even keep them out of the hospital.”
Direct support for the Phase 1 and Phase 1b clinical trials of SAB-185 is provided by the U.S. 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). For more information on the Phase 1b trial, please visit https://clinicaltrials.gov (Identifier: NCT04469179).
SAB-185 is a fully-human, specifically targeted and broadly neutralizing polyclonal antibody therapeutic candidate for COVID-19. The therapeutic was developed from SAB’s novel proprietary DiversitAb™ Rapid Response Antibody Program in collaboration with the USG. CSL Behring is engaged for clinical manufacturing for the definitive trials. SAB filed the Investigational New Drug (IND) application and produced the initial clinical doses in just 98 days from program initiation. The novel therapeutic, generated from a subunit of the SARS-CoV-2 Wuhan strain, has shown neutralization of both the Munich and Washington strains in preclinical studies. Preclinical data has also demonstrated SAB-185 to be more potent than human-derived convalescent immunoglobulin G (IgG).
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. Utilizing some of the most complex genetic engineering and antibody science in the world, SAB has developed a unique platform that can rapidly produce natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale. SAB-185, a fully-human polyclonal antibody therapeutic candidate for COVID-19, is being developed with initial funding supported by the Biomedical Advanced Research Development Authority (BARDA), part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services and the Department of Defense (DoD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO – CBRND) Joint Project Lead for Enabling Biotechnologies (JPL-EB). In addition to COVID-19, the company’s pipeline also includes programs in Type 1 diabetes, organ transplant and influenza. For more information visit: www.sabbiotherapeutics.com or follow @SABBantibody on Twitter.