First participant dosed in Phase 1 study of SAB-185 for COVID-19 in healthy volunteers
Phase 1b clinical trial evaluating the safety and pharmacological activity of SAB-185 in COVID-19 patients slated to start mid-August
Novel proprietary technology platform leverages the native human immune response offering a differentiated high-potency therapeutic option to address virus mutations amidst ongoing pandemic
August 11, 2020 08:41 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 specifically targeted, high potency, fully human polyclonal antibodies without the need for human serum, today announced that the first participant has been dosed in its Phase 1 study evaluating the safety of SAB-185, a therapeutic candidate for COVID-19, in healthy volunteers. SAB-185, a highly potent polyclonal antibody therapeutic, could potentially treat ill patients and provide protective antibodies that could have significant value to protect the military, front-line responders, mission-critical staff, and high-risk populations against COVID-19.
“This is a critical time in the global fight against COVID-19 and we believe that SAB-185, a fully-human polyclonal antibody, has the potential to serve as a differentiated therapeutic option. SAB-185 is supported by recently published preclinical data, which demonstrate that our novel immunotherapy platform can successfully neutralize mutated strains of viruses,” said Eddie J. Sullivan, co-founder, president and CEO of SAB Biotherapeutics. “Further, SAB-185 preclinical data has demonstrated highly-potent neutralizing antibodies to SARS-CoV-2 that are more potent than human convalescent plasma serum samples available against the virus. Taken together, these data suggest that SAB-185 may be effective even as SARS-CoV-2 continues to evolve. We are excited to be one step closer to realizing our vision of advancing a new class of immunotherapies that leverage the native human immune response and match the evolution of human disease amidst this global pandemic, and look forward to initiating our Phase 1b study of SAB-185 in COVID-19 patients.”
SAB’s technology leverages the native human immune response providing a highly-specific match against the complexity, diversity and mutation of disease. A recent Frontiers in Microbiology article highlighted preclinical data demonstrating SAB’s novel highly-potent, fully-human polyclonal antibody therapeutic for hantavirus was effective against both original and mutated strains of the virus and capable of binding multiple targets and epitopes, providing benefit over conventional approaches. SAB’s therapeutic candidate, SAB-185, is specifically targeted to SARS-CoV-2 and designed to work synergistically with a patient’s own immune system to both neutralize the virus and activate other immune system components that are important in helping the body fight disease. This is particularly important with rapidly mutating targets such as viruses and anti-microbial resistant bacteria.
The Phase 1 healthy volunteer clinical trial is a randomized, double-blind, single and multiple ascending dose study of SAB-185 in 28 healthy participants with safety as the primary endpoint.
Direct support for the Phase 1 and Phase 1b Clinical Evaluation 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).
The Phase 1 clinical evaluation of SAB-185 supports the continued development of SAB-185; initially awarded in April by DOD’s Joint Project Lead-Enabling Biotechnologies (JPL-CBRND-EB) with funding from the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA). Since April, the initial agreement’s scope has broadened to include enhanced capacity and operations to expand manufacturing of the SAB-185 COVID-19 Drug Product. This effort has backing from DoD JPEO Rapid Response Initiatives, Defense Health Program COVID-19 Vaccine Acceleration, and BARDA in support of “Operation Warp Speed”, a partnership between HHS divisions, including the National Institutes of Health (NIH), Food and Drug Administration (FDA), ASPR’s BARDA, and DoD commands to move promising vaccines and therapies through regulatory review as rapidly as possible.
SAB has announced three awards valued at $72 million since March 2020 for development of its COVID-19 therapeutic candidate and for scaling its rapid response capacity and capabilities for current and future product development from discovery through licensure.
“We are determined to make a difference and help patients with our innovative new technology when it is needed most. We are proud to partner with JPEO and BARDA using science as the solution,” added Sullivan. “Our team is working together with private, public, government, and academic collaborations at a diligent and accelerated pace to combat this global health crisis while providing a truly responsive model for future emerging diseases and biothreats.”
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 the only 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.