SAB Biotherapeutics (SAB, Nasdaq: SABS), a clinical-stage
biopharmaceutical company with a novel immunotherapy platform that
produces specifically targeted fully-human multi-epitope binding
immunoglobulin (hIgG) antibodies, also known as fully-human
polyclonal antibodies, without the need for human donors, today
announced the U.S. Food and Drug Administration has approved five
of seven sections required for the Company’s pending New Animal
Drug Application (NADA) for the company’s antibody-generating
platform in Transchromosomic (Tc) bovine.
SAB is in the process of completing the
remaining two sections of the NADA. Upon formal acceptance of the
seven-step safety and effectiveness evaluation, the company will
use this approval in support of Biologics License Applications
(BLAs) with the FDA Center for Biologics Evaluation and Research
(CBER) for its hIgG antibody investigational drugs.
“SAB is the only company in the world
progressing this kind of advanced genetic engineering to develop
rapid, scalable production of highly potent, fully-human polyclonal
IgG antibodies, without the need for human donors,” said Eddie J.
Sullivan, Ph.D., co-founder, President, and Chief Executive Officer
of SAB Biotherapeutics. “The FDA has an established regulatory
pathway to review our cutting-edge science, and we are pleased to
be making significant progress. This process is a one-time approval
that will be applicable for all subsequent investigational products
produced from the DiversitAb™ platform using our transchromosomic
bovine. SAB is focused on a successful completion of NADA to
rapidly pursue BLA approvals for our investigational
therapeutics.”
SAB continues to work closely with the FDA’s
Center for Veterinary Medicine (CVM) and CBER to establish a NADA
approval for the Company’s Tc bovine-based antibody-generating
platform. In following this regulatory pathway, SAB’s proprietary
platform will be further protected from any potential future
generic competition beyond the 12-year exclusivity timeframe
typically granted to newly approved biologics. Other FDA approved
human therapeutics for patients have successfully utilized the NADA
process.
“The NADA process is complex and our progress in
completing five out of seven sections further solidifies our
leading position in delivering fully human multi-epitope binding
antibody treatments without a need for human donors,” said
Alexandra Kropotova, MD, Chief Medical Officer of SAB
Biotherapeutics. “We have a clinically validated platform with a
clear regulatory path which has been used to develop products that
we’ve taken to Phase II and III clinical trials. Recent
Breakthrough Therapy and Fast Track designations for one of our
leading compounds further support our regulatory path that is
well-established and de-risked. Few, if any, other companies have
the same capability.”
SAB’s Tc Bovine are a unique and proprietary
component of SAB’s DiversitAb™ platform that creates exponentially
higher amounts of hIgG antibody treatments with preferential
pharmacological properties compared to animal-derived or synthetic
human monoclonal immunotherapies. Cows are ruminant animals that
inherently have a more robust immune response than humans. This
response is stimulated when an immunogen specific and exclusive to
a target is introduced to SAB’s Tc Bovine and boosted further with
a specialized formulation and strategy that maintains a high level
of antibody production over an extended period of time. This
technology enables batch-to-batch consistency of large amounts of
diverse, high-titer, high-avidity hIgG antibodies, which lead to a
nearly endless supply of high-potency therapeutics—without the need
for human donors.
SAB is leveraging its DiversitAb platform to
discover and develop product candidates with the potential to be
first-in-class or best-in-class against complex targets to treat or
prevent diseases with significant unmet medical needs. These
include infectious respiratory and gastroenterological diseases,
autoimmune disorders, and oncology. DiversitAb™ is a proven
platform with recent regulatory validation, with the FDA granting
both Fast Track designation and Breakthrough Therapy designation to
SAB-176, an investigational therapeutic for Type A and Type B
influenza illness in high-risk patients, including those who have
anti-viral resistant strains. SAB also recently announced positive
top-line results from the Phase 3 National Institutes of Health’s
(NIH) ACTIV-2 clinical trial that assessed SAB-185 in
non-hospitalized people with COVID-19 who were at high risk for
severe outcomes with demonstrated efficacy against the Omicron
variant.
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
StatementsCertain 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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