SIOUX FALLS, S.D.--(BUSINESS WIRE)--SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company developing a novel immunotherapy platform to produce specifically targeted, high potency, fully-human polyclonal antibodies, today announced that the first patient has been dosed in its Phase 2/3 study evaluating the safety and efficacy of SAB-185, a polyclonal antibody therapeutic candidate in non-hospitalized adults with mild to moderate COVID-19 as part of the NIH’s ACTIV-2 master protocol. The Phase 2/3 study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). SAB-185 is currently being evaluated in Phase 1 and Phase 1b studies for the treatment of COVID-19, both of which have completed enrollment.
“As the COVID-19 pandemic continues to have an impact globally, we are committed to working collaboratively with our government to overcome this health crisis. Our team is excited to be advancing SAB-185, a potent fully-human polyclonal antibody therapeutic, that offers a highly-differentiated potential treatment for patients,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics.
SAB is collaborating with the NIH-NIAID to conduct the Phase 2/3 trial of SAB-185 as part of the ACTIV-2 master protocol. The trial is a randomized, double-blind, adaptive study that will examine the clinical safety and efficacy of SAB-185 in addition to standard of care in non-hospitalized patients with mild to moderate COVID-19 at risk for disease progression. Each sub-study in ACTIV-2 shares the placebo group and plans to enroll 110 participants. SAB-185 is administered intravenously and will be evaluated in a high- and low-dose arm. Multiple primary endpoints will be assessed including the duration of COVID-19 symptoms and the quantification of viral load on multiple timepoints through day 28.
“This is a critical time in the fight against COVID-19, particularly as the virus continues to mutate. SAB-185, developed from our proprietary DiversitAb™ platform, harnesses the native human immune response and allows us to target a polyclonal response, driving high levels of potency not seen before and providing a match against future SARS-CoV-2 mutants. We look forward to continuing to advance both our COVID-19 program and our novel platform to develop potent targeted therapies that address the emergence, mutation, and diversity of today’s diseases,” added Sullivan.
NIH's Accelerating COVID-19 Therapeutic Inventions and Vaccines (ACTIV) is a public-private partnership to develop a coordinated research strategy to speed up the development of the most promising treatments and vaccine candidates for COVID-19 and has five adaptive master protocols for ACTIV clinical trials. ACTIV-2 is a master protocol designed for evaluating multiple investigational agents compared to placebo in adults with mild-to-moderate COVID-19, not requiring hospitalization.
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, Washington and other variant strains in preclinical studies. Preclinical data has also demonstrated SAB-185 to be significantly more potent than human-derived convalescent immunoglobulin G (IgG).
Direct support for the development 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) and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, under contract #MCDC 2019-448.
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 the only platform that can rapidly produce natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale. In addition to COVID-19, the company’s pipeline also includes programs in Type 1 diabetes, organ transplant, influenza and a human immune globulin (IgG) to treat autoimmune diseases. For more information visit: www.sabbiotherapeutics.com or follow @SABBantibody on Twitter.