First High-Potency Human Polyclonal Antibody Therapeutic Specifically Designed with the Potential to Treat Rapidly-Mutating Type A and Type B Influenza Viruses

SIOUX FALLS, SD, USA I June 29, 2021 I SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies, today announced that the first participant has been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of SAB-176 in a human challenge study. SAB-176 is a novel anti-influenza human immunoglobulin G (IgG) immunotherapy designed to address the limitations of current treatments for moderate to severe seasonal influenza. It is a high-potency multivalent human polyclonal antibody therapeutic designed specifically to treat or prevent Type A and Type B seasonal and pandemic influenza virus infections.

“With the devastating health and economic impacts of seasonal influenza and hundreds of thousands of hospitalizations and deaths annually, more effective therapies for moderate to severe cases are needed. We are excited to be advancing SAB-176, a novel high-potency immunotherapy with the unique ability to simultaneously target Type A and B influenza, including emerging and mutating strains,” said Eddie J. Sullivan, PhD, co-founder, president and CEO of SAB Biotherapeutics. “SAB-176 has the potential to complement seasonal vaccine programs, to achieve better efficacy than small molecule anti-influenza antivirals in the general population, and to serve as a valuable prophylactic in high-risk populations. We look forward to progressing this promising therapy, which harnesses the unique attributes of our fully-human polyclonal antibody platform, to address highly-mutating viruses that have significant annual health impacts as well as pandemic potential.”

The Phase 2a trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and treatment efficacy of SAB-176 in 60 healthy adults challenged with a pandemic influenza virus strain (pH1N1). For more information on the study, visit clinicaltrials.gov (Identifier: NCT04850898). SAB-176 is also being evaluated in an ascending dose, double-blind, randomized, placebo-controlled Phase 1 safety trial in healthy volunteers. SAB expects to report data from this study in the fourth quarter of 2021.

About SAB-176

SAB-176 is a multivalent, broadly neutralizing fully-human polyclonal antibody therapeutic candidate in development for the treatment, or prevention, of severe influenza. The novel, specifically-targeted therapeutic leverages the natural human biological immune response to specifically bind to Type A and Type B influenza viruses. It can also be modified to address annual strain changes when needed. Preclinical data suggests that SAB-176 offers broad protection against diverse influenza strains.

About Seasonal Influenza

According to the US Centers for Disease Control (CDC), on average about 8% of the US population gets sick from flu each season and between 12,000 and 61,000 infected Americans die, depending on the severity of the season. In 2019-2020, considered a moderate flu season, 38 million people in the US became ill with the flu, 18 million saw a healthcare provider for treatment, 400,000 were hospitalized and an estimated 22,000 died. Globally, there are between 2.5 and 5 million influenza-related hospitalizations per year. The CDC recommends an annual flu shot for almost everyone over the age of six months, but each year less than half the population is vaccinated. In addition, because influenza viruses are highly mutating, the vaccines have varying levels of protection in any year, but rarely exceed 50% protection. Young children, the elderly, immune-compromised individuals and patients with chronic health conditions are especially at risk of poor outcomes from influenza.

About SAB Biotherapeutics, Inc.

SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company advancing a new class of immunotherapies based on its human polyclonal antibodies. SAB has applied advanced genetic engineering and antibody science to develop transchromosomic (Tc) Bovine herds that produce fully-human antibodies targeted at specific diseases, including infectious diseases such as COVID-19 and influenza, immune system disorders including type 1 diabetes and organ transplantation, and cancer. SAB’s versatile and scalable DiversitAbplatform is applicable to a wide range of serious unmet needs in human diseases. It rapidly produces natural, specifically-targeted, high-potency, human polyclonal immunotherapies at commercial scale. SAB is currently advancing multiple clinical programs and has a number of collaborations with the US government and global pharmaceutical companies. On June 22, 2021, SAB announced a planned merger with Big Cypress Acquisition Corp. (NASDAQ: BCYP), The transaction is expected to close in the fourth quarter of 2021. For more information on SAB, visit: www.sabbiotherapeutics.com and follow @SABBantibody on Twitter.

SOURCE: SAB Biotherapeutics