SAB Biotherapeutics (Nasdaq: SABS), ("SAB”), a clinical-stage
biopharmaceutical company with a novel immunotherapy platform that
produces specifically targeted, high-potency, fully-human
polyclonal antibodies without the need for human donors, today
announced that the Company presented an overview of its DiversitAb™
polyclonal platform and data on SAB-176 and SAB-185 showing the
benefits of fully-human polyclonal antibodies derived from SAB’s
Transchromosomic (Tc) Bovine™ over plasma derived antibodies from
humans, at the 2022 Plasma Product Biotechnology Conference
in Limassol, Cyprus, which concluded on Nov. 3.
SAB’s Chief Operating Officer Christoph Bausch, Ph.D., led two
presentations at the conference on Tuesday, Nov. 1.
In a presentation titled, “Plasma fractionation and downstream
processing of human polyclonal antibodies from
the DiversitAb™ platform,” Dr. Bausch presented an overview of
SAB’s novel immunotherapy platform utilizing a specialized
manufacturing process to enable a scalable and reliable production
of targeted, higher-potency neutralizing antibody products than has
been previously possible. The platform can reliably and rapidly
produce large quantities of fully-human immunoglobulins against a
variety of disease targets, such as viruses, bacteria, toxins, and
cancers, without the need for convalescent plasma from human donors
with a significantly simplified and controlled process. Tc Bovine,
SAB’s genetically engineered cows, mount the same immune response
as humans, only with a much higher concentration of targeted
neutralizing antibodies. In addition, by eliminating the need to
identify, screen, and draw blood from recovering volunteers, SAB’s
approach opens the door to polyclonal antibody therapeutics that
are potentially more potent, safer, and longer-lasting than current
antibody therapies.
“SAB’s platform is a major advancement in plasma science and
allows for a large supply of neutralizing, fully-human antibodies
that can be targeted to treat a number of challenging diseases,”
Dr. Bausch said. “Our novel approach to creating high-potency,
high-avidity antibodies that naturally activate cellular immunity
using our transchromosomic cows has the potential to profoundly
change how we approach and treat a wide range of diseases.”
Titled “Phase 2 efficacy and safety of two novel SAB
immunotherapies against respiratory disease indications
associated with highly mutating viruses,” Dr. Bausch’s second
presentation outlined data on SAB-185 for COVID-19 and SAB-176 for
seasonal and pandemic influenza. The data show that SAB-185 and
SAB-176 are highly effective against variants of several highly
mutating viruses associated with the diseases, a major challenge in
currently available treatments for COVID-19 and influenza.
Data from the in vitro neutralizing capacity of SAB-185 was
tested against 10 variant SARS-CoV-2 strains, including several
Omicron variants. SAB-185 exhibited equivalent neutralization of
the Munich, Alpha, Beta, Gamma variants and a variant isolated from
an immunocompromised patient (D144-146) and retained neutralization
of the Delta variant AY.1 and multiple Omicron variants from BA.1
through BA.5, with only modest losses of neutralization activity.
For in vivo protection studies, SAB used a human ACE2 (hACE2)
transgenic Syrian hamster model that exhibits rapid lethality after
intratracheal SARS-CoV-2 challenge with the Munich, Alpha, Beta,
Delta, and D144-146 variants; the Omicron B.1.1529 variant resulted
in a delayed, less severe, and non-lethal disease. Prophylactic
SAB-185 treatment protected the hamsters from death and minimized
clinical signs of infection when challenged with the variant
viruses tested.
Also outlined was a Phase 2a, Randomized, Double-Blind Trial in
H1N1 Challenged Adults, which showed that SAB-176 met its primary
endpoint of reducing the nasopharyngeal viral load in subjects
challenged with H1N1 A/California/2009-like virus. SAB-176 also met
secondary endpoints of reducing symptoms by Day 4 and shortened the
timeframe of the ability to culture virus in vitro, suggesting
reduced viral shedding, and was safe and well tolerated. Further,
while SAB-176 was developed against recent seasonal influenza A and
B strains, it also demonstrated efficacy against the 2009 pandemic
H1N1 strain in this clinical trial. These clinical results were
anticipated as SAB-176 showed significant preclinical HAI titers to
multiple current and previous seasonal Type A and Type B influenza
strains.
“SAB’s data on SAB-176 and SAB-185 validated that our platform
delivers on its promise and can create fully-human antibodies that
offer much broader efficacy in highly mutating pathogens,” Dr.
Bausch said. “The data show the antibodies cross react to mutating
strains, preventing additional mutations, and shorten the time of
infectious viral shedding to reduce the spread of disease. These
components are critical in developing effective innovative future
treatments.”
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB) We are 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, including the development and
efficacy of our influenza program, C. diff. program, Type 1
Diabetes program, and other discovery programs, the likelihood that
a patent will issue from any patent application, the results,
including timing, of the development of SAB-176, SAB-185, and
SAB-195 (including any IND filing or proposed clinical trials),
financial projections and future financial and operating results
(including estimated cost savings and cash runway), the outcome of
and potential future government and other third-party
collaborations or funded programs (including negotiations with the
DoD). 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.
CONTACTS:
Investor Relations:SABIR@westwicke.com
Media Relations:SABPR@westwicke.com
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