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.
Investor Relations:SABIR@westwicke.com
Media Relations:SABPR@westwicke.com
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