July 30, 2020 08:48 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 fully human polyclonal antibodies without the need for human donors, today announced that the first participant has been dosed in its Phase 1 clinical trial evaluating SAB-176 for the treatment of seasonal influenza. SAB-176 is a novel anti-influenza human immunoglobulin G (IgG) immunotherapy designed to address the limitations of current treatment for severe seasonal influenza. This fully human polyclonal antibody therapeutic targets four influenza virus strains in a way similar to the natural way our bodies fight the disease.
“The initiation of our Phase 1 study of SAB-176 marks a significant milestone for this program developed from our novel technology platform which aims to generate fully-human immunoglobulins without human serum in order to transform the treatment and prevention of a broad range of diseases,” said Eddie J. Sullivan, PhD, President, CEO and Co-Founder of SAB. “SAB-176 is a novel immunotherapy designed to address the unmet need for the treatment of seasonal influenza. SAB-176’s unique properties allow for adaptation to future emerging and mutating seasonal strains, an attribute that has also been shown to be of high importance in other viral diseases, particularly in light of the COVID-19 pandemic and the emerging public health crisis.”
The Phase 1 clinical trial is a randomized, double-blind, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of SAB-176 delivered intravenously in 27 healthy participants. The study is intended to inform the dosing for Phase 2 including effective dose ranges. Preclinical studies of SAB-176 demonstrated high potency and neutralization against various influenza strains. The healthy volunteer study is expected to be completed in early 2021.
About Seasonal Influenza
Seasonal influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. Despite available antivirals and vaccines, influenza continues to cause substantial morbidity and mortality worldwide. According to the Centers for Disease Control and Prevention (CDC), influenza has resulted in up to 45 million illnesses, up to 810,000 hospitalizations, and up to 61,000 deaths annually since 2010 in the United States alone.
SAB-176 is a quadrivalent broadly neutralizing fully-human polyclonal antibody therapeutic candidate that leverages the human biological immune response in development for the treatment of hospitalized patients with severe seasonal influenza. The novel specifically targeted therapeutic generated from the company’s proprietary technology, the DiversitAb™ platform, is designed to specifically bind to Type A and Type B influenza viruses. Pre-clinical data suggests that SAB-176 offers potentially broad protection against diverse influenza strains. A highly-potent, polyclonal antibody therapy for severe seasonal influenza, could potentially treat severely ill patients and provide protective antibodies for high-risk populations, such as the elderly and immune compromised.
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 support 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 through an existing Rapid Response contract with 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.