SAB Biotherapeutics Initiates IND-Enabling GLP Toxicology Study for SAB-142, Novel Immunotherapeutic for Type 1 Diabetes
November 21 2022 - 8:14AM
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 SAB-142 is being progressed as a therapeutic agent to
prevent and/or delay onset and progression of Type 1 diabetes (T1D)
and potentially other T-cell mediated autoimmune diseases. In an
IND-enabling GLP study, SAB-142 will be compared to an FDA-approved
T-cell depleting therapeutic, to assess toxicity and
pharmacodynamic effects.
Because SAB-142 is a fully-human polyclonal
antibody, it is expected to be much less immunogenic, safer, and
more effective in preventing and/or delaying onset and progression
of T1D as compared to other commercially available products such as
fully-animal antibodies and other monoclonal lymphodepletion
therapeutics. SAB-142 is fully-human therapeutic that may be
administered multiple times without inducing immune-mediated
reactions including immediate anaphylaxis or delayed serum
sickness.
“Type 1 diabetes is an autoimmune disease that
represents a staggering unmet patient need,” said Alexandra
Kropotova, MD, Chief Medical Officer of SAB Biotherapeutics.
“Patients in the Americas are disproportionally affected by Type 1
diabetes. From 1990 to 2019, the death rate increased in the
Americas by 13.5%, in contrast to a decreasing global rate of
–9.3%. The initiation of this study supports the progression of our
SAB-142 immunotherapeutic towards IND filing. As such, we are
aiming toward a successful IND submission for this novel
immunotherapy that can positively impact the health of millions of
patients with Type 1 diabetes across the globe.”
In the GLP toxicology study, conducted in an
appropriate model, SAB-142 will be dosed at 1, 5, and 10 mg/kg and
commercially available anti-thymocyte globulin will be dosed at 5
mg/kg. The study is expected to be completed in the first quarter
of 2023.
About SAB Biotherapeutics
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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