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, or fully human
polyclonal) antibodies, without the need for human donors,
announced today that the U.S. Food and Drug Administration (FDA)
has granted Breakthrough Therapy Designation (BTD) to SAB-176, an
investigational therapeutic, for post-exposure prophylaxis for Type
A and Type B influenza illness in high-risk patients, including
those who have anti-viral resistant strains. On April 13, SAB
announced that the FDA had granted Fast Track designation to
SAB-176, and that the company had 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.
The FDA’s Breakthrough Therapy designation
process is designed to expedite the development and review of a
medicine that is intended to treat a serious or life-threatening
condition and preliminary clinical evidence indicates that the drug
may demonstrate substantial improvement over therapies currently
available on a clinically significant endpoint(s). Products that
qualify for Breakthrough Therapy designation receive more benefits
than Fast Track products.
“Influenza continues to pose considerable health
concerns both in the U.S. and on a global scale. This Breakthrough
Therapy designation signifies an important step forward in our
fight against this disease," said Eddie Sullivan, PhD, co-founder,
President & CEO of SAB Biotherapeutics. "Even though both
designations can be requested early in development, the
requirements for Breakthrough Therapy designation are higher than
those for the Fast Track program. For Breakthrough Therapy
designation, the improvement demonstrated must be substantial. We
are proud that based on generated preclinical and clinical
evidence, SAB-176 has received both Breakthrough and Fast Track
designations, a combination rarely seen. These designations further
assure us that SAB-176 has a clear regulatory and clinical
development path to progress this important therapeutic.”
SAB-176 is being developed for several influenza
indications, including treatment of high-risk patient populations,
as well as pre- and post-exposure prophylaxis. The FDA’s
Breakthrough Therapy designation confirms that the multi-epitope
targeting modality of SAB-176 has a clear differentiation vs.
monoclonal antibodies (mAb) that bind to a single epitope, and
SAB’s treatment can sustain its efficacy over viral mutations and
prevent or reduce the risk of emerging treatment-resistant
influenza strains. Virus evolution driven by vaccines or treatments
is a serious challenge and the use of therapeutics can create
“escape mutants” or versions of a virus that have changed to escape
pressure on virus survival driven by an antiviral treatment,
whether it is a small molecule or monoclonal antibody modality.
Clinical evidence for SAB-176 generated in the
SAB-176-201 clinical trial showed a significantly shorter time to
resolution of positive viral culture vs. the control group. SAB’s
DiversitAb™ platform data also showed that the multi-epitope
binding modality of SAB’s biologic treatments reduces risk for
emergence of treatment-resistant viruses. Preclinical evidence of
in vivo efficacy of SAB-176 in the treatment-resistant strains
further supports the scientific foundation for this Breakthrough
designation.
SAB-176 is a highly potent immunotherapy that is
grounded in fundamentals of the natural immune response to
neutralize Type A and Type B influenza viruses by generating
endogenous multi-epitope binding antibodies. 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 (CDI or C.
diff), autoimmune disorders, such as type 1 diabetes, and
cancers.
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 across seasonal and
pandemic strains of Influenza A and lineages of influenza B
including strains that were not specifically targeted in the
manufacturing of the therapeutic. At the same time, the FDA
guidance and regulatory alignment received by the company paves the
way for changing the strains that are specifically targeted by the
product over time to potentially ensure that the product maintains
efficacy as the virus mutates over time.
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 the 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 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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