SAB Biotherapeutics (Nasdaq: SABS), (SAB), a clinical-stage
biopharmaceutical company with a novel immunotherapy platform that
produces specifically targeted, high-potency, fully-human,
multi-epitope binding immunoglobulin (hIgG) antibodies, without the
need for human donors, announced today that the US Food and Drug
Administration (FDA) has granted Fast Track designation for
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. The Fast Track designation is
designed to facilitate accelerated development and expedited review
of medicines that treat critical illnesses and address an unmet
medical need, with the goal of having promising treatments reaching
approval and patients as quickly as possible.
SAB also received FDA guidance and regulatory
alignment on advancing SAB-176 into the next phase of development
through initiation of a Phase 2b dose-range finding efficacy and
safety trial in patient populations at high-risk for developing
severe disease.
SAB-176 is a novel, highly potent immunotherapy
that is grounded in fundamentals of the natural immune response to
neutralize Type A and Type B influenza viruses, which mutate
rapidly. SAB-176 is also being studied in emerging and mutating
pandemic strains by targeting multiple epitopes of the virus rather
than a single epitope. The treatment is produced using SAB's
proprietary DiversitAb™ platform, which enables—for the first
time—rapid, scalable production of highly potent, fully-human
polyclonal IgG antibodies, without the need for human donors. The
platform is capable of addressing the emergence and diversity of
modern health challenges, including seasonal and pandemic
influenza, COVID-19, Clostridioides difficile (C. diff), and
autoimmune disorders, such as type 1 diabetes, and cancers.
"We are pleased to receive the FDA Fast Track
designation for SAB-176. Influenza continues to be one of the
biggest public health challenges the world faces on a continuing
basis, with an excessively high number of hospitalizations and
deaths each year," said Eddie Sullivan, PhD, co-founder, President
& CEO of SAB Biotherapeutics. "We are excited about the
potential role SAB-176 can play in tackling a highly mutagenic
pathogen like influenza."
SAB-176 has undergone multiple clinical and
pre-clinical studies, including a Phase 1 trial in healthy
volunteers and a Phase 2a challenge study completed last year. The
data indicate that SAB-176 offers broad antibody protection against
multiple strains of this rapidly mutating virus. In the Phase 2a
study, SAB-176 showed broad cross protection that included strains
that were not specifically targeted in the manufacturing of the
therapeutic.
In addition to the Fast Track designation, SAB
Biotherapeutics has also received FDA guidance and regulatory
alignment on advancing SAB-176 into the next phase of development,
including a Phase 2b trial study design. The study will evaluate
the safety and efficacy of SAB-176 in high-risk patients with Type
A or Type B influenza illness, including those who have anti-viral
treatment resistant strains. In addition, the FDA aligned with
SAB’s manufacturing approach, which includes a plasma pooling
strategy allowing hyperimmunization to address multiple strains of
influenza on an annual basis. This paves the way for SAB to address
strain changes, similar to how seasonal influenza vaccines are
developed.
"SAB-176 has the potential to be a game-changer
in the fight against influenza," said Alexandra Kropotova, MD,
Chief Medical Officer of SAB Biotherapeutics. "Its multi-pronged
mechanism of action, long half-life, and low risk of emergence of
resistant strains could make it a superior therapeutic to achieve
and sustain efficacy against this ever-evolving virus. We see this
Fast Track designation as a testament to the promise of our
innovative DiversitAb platform, which is equipped to rapidly
respond to mutating infectious diseases like influenza."
The CDC estimates that there are an average of 9
to 41 million cases of influenza each year in the US, with
140,000-710,000 hospitalizations and 12,000-52,000 deaths per year.
While Tamiflu® is an effective therapy for treating influenza if
used within two days of symptom onset, some patients still develop
severe disease and resistant strains of influenza to anti-viral
drugs has increased in recent years. SAB-176 offers the potential
for an additional treatment for influenza, particularly in
higher-risk patients.
The DiversitAb platform is a first-of-its-kind
technology capable of producing large amounts of fully-human
high-titer, high-avidity multi-epitope binding antibodies across
multiple targets without a need for human donors. SAB is leveraging
its proprietary 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, immune and autoimmune disorders, and
oncology.
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 the outcome of and 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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