First fully-human multi-epitope binding broadly neutralizing immunoglobulin antibody therapeutic being developed for treatment of high-risk patients demonstrates safety and efficacy in Phase 1 and 2a Trials
SAB-176 and oseltamivir combination therapy shows promising results in preclinical studies
SIOUX FALLS, S.D., May 04, 2023 (GLOBE NEWSWIRE) -- SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human immunoglobulin (hIgG,) antibodies, also known as fully-human polyclonal antibodies, without the need for human donors, today announced the presentation of positive safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176 at the AVG conference, which is hosted by the International Society for Influenza and other Respiratory Virus Diseases (ISIRV) in Seattle, Wash.
SAB-176 is a fully-human, broadly neutralizing immunoglobulin antibody therapeutic designed to prevent or reduce severe outcomes of Type A and Type B influenza infection in patients at high risk for severe complications, including in patients who are immunocompromised. It has recently received both Breakthrough Therapy and Fast Track Designation from the United States Food and Drug Administration (FDA).
Taking place from May 3-5, 2023, the ISIRV-AVG conference is a premier international forum for influenza research, attracting leading experts in the field from around the world. SAB will conduct an oral presentation, titled “Safety and efficacy results from Phase 1 and 2a trials using an anti-Type A and B influenza immunotherapeutic,” on Thursday, May 4, at 11:20 AM PT. The presentation will be given by Thomas Luke, MD, Sr. Vice President, Research.
"We are excited to present the latest positive findings on SAB-176 at the highly regarded ISIRV-AVG conference," said Eddie Sullivan, co-founder, President and Chief Executive Officer of SAB Biotherapeutics. "Our innovative platform has demonstrated promising safety and efficacy results in preclinical and clinical studies, paving the way for a potential paradigm shift in influenza management, particularly among the most vulnerable populations. Following Breakthrough Therapy and Fast Track designations granted by the FDA in April, we couldn't think of a better venue than the ISIRV-AVG conference to share our exciting progress with the world's leading influenza experts."
In a Phase 2a challenge clinical trial, healthy adults (n=60) were given a 25 mg/kg dose of SAB-176 or placebo after being inoculated with H1N1. Results showed that SAB-176 was safe, well-tolerated, and demonstrated a significant reduction in viral load compared to placebo, as well as symptom reduction.
Moreover, a preclinical study in mice indicated that the combination of low doses of SAB-176 and oseltamivir (Tamiflu®) provided protection against a lethal dose of H1N1 comparable to a high-dose of oseltamivir alone, highlighting the potential additive benefits of low dose combination therapy.
To view the AVG program online, please click here.
More information on SAB-176’s influenza therapeutic candidate can be found on the pipeline page of SAB’s website: sab.bio/sab-176.
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) is a clinical-stage biopharmaceutical company focused on the development of powerful and proprietary immunotherapeutic polyclonal human antibodies to treat and prevent infectious diseases and immune and autoimmune disorders. Our development programs include infectious diseases resulting from outbreaks and pandemics, as well as immunological, gastroenterological, and respiratory diseases that have significant mortality and health impacts on immune compromised patients. SAB has applied advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™. Our versatile DiversitAb™ platform is applicable to a wide range of serious unmet needs in human diseases. It produces natural, specifically targeted, high-potency, fully-human polyclonal immunotherapies without the need for human donors. SAB currently has multiple drug development programs underway and collaborations with the US government and global pharmaceutical companies. For more information on SAB, visit: https://www.SAb.bio/ and follow SAB on Twitter and LinkedIn.
Forward-Looking Statements
Certain statements made herein that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, the development and efficacy of our influenza program, C. diff. program, type 1 diabetes program, and other discovery programs, the results, including timing, of the development of SAB-176, SAB-185, SAB-142 and SAB-195, including SAB-176 Fast Track designation and Breakthrough Therapy designation, and the outcome of potential future government and other third-party collaborations or funded programs.
These statements are based on the current expectations of SAB and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.
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