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 the company has entered into an exclusive manufacturing
services agreement with Emergent BioSolutions Inc. (NYSE: EBS).
Emergent will provide contract development and manufacturing (CDMO)
services to produce SAB’s fully-human polyclonal antibody products.
Currently, SAB has clinical-stage programs in pan-influenza
treatment, treatment of acute and recurrent C. diff., prevention of
Type 1 diabetes, and discovery assets in immunology and oncology.
Under the terms of the agreement, Emergent will provide
end-to-end Good Manufacturing Practice (cGMP) manufacturing
services to SAB, including process development and manufacturing
clinical investigational drug product to support SAB’s clinical
programs, and commercial manufacturing services upon regulatory
approval of SAB’s therapeutics. The agreement also provides the
opportunity for Emergent to utilize SAB’s novel DiversitAb™
platform, the only one in the world that produces fully-human
polyclonal antibodies utilizing transchromosomic cows, for future
development of undisclosed programs. Financial details of the
agreement were not disclosed.
“Emergent is a world leader in plasma purification from both
humans and animals and excels in this specialized area of drug
development and manufacturing,” said Eddie Sullivan, co-founder,
President and Chief Executive Officer of SAB Biotherapeutics.
“Partnering with Emergent at this stage allows SAB to focus solely
on research and development of our polyclonal antibody drug
candidates. In Emergent, we’ve found a terrific partner with highly
specialized expertise and experience with our novel approach.”
SAB’s technology platform leverages the natural human immune
response to develop next-generation, fully-human polyclonal
antibody therapeutics without the need for human plasma, extending
both safety and potency. These high-avidity antibodies have
proven to neutralize a broad spectrum of pathogens and treat
disease, and address mutation, an advantage over monoclonal
antibody therapeutics. SAB’s platform represents, for the first
time, the ability to produce targeted, fully-human, high-potency
polyclonal therapies on a commercial scale. SAB’s novel platform
can consistently and reliably produce fully human antibodies
without the need for convalescent plasma from human donors. Tc
Bovine™ – SAB’s genetically engineered cows – mount the same immune
response as humans, only with a much higher concentration and
potency of targeted neutralizing antibodies directed at multiple
pathogens and in large quantities, through a more simplified and
controlled process than has previously been possible.
“Emergent is pleased to leverage its deep expertise in the
complex process development and manufacturing of plasma-derived
therapies to support SAB’s clinical and potentially commercial
therapeutic programs,” said Bill Hartzel, senior vice president and
Head of the CDMO Business at Emergent BioSolutions. “As one of
Canada’s most successful, longest standing pharmaceutical
manufacturing sites, Emergent’s Winnipeg facility is uniquely
equipped to offer integrated drug substance and drug product
manufacturing services to help bring SAB’s critical and novel drug
candidates to patients around the globe.”
Emergent has deep expertise with plasma products generated for
targeted therapies. For decades, Emergent’s hyperimmune specialty
plasma antibody manufacturing platform has been used to create
multiple drugs up to a scale of 1000L. This includes its human
platform, purified gamma globulin (IgG) containing polyclonal
antibodies to specific antigens obtained from human plasma, and its
equine platform, purified immunoglobulin fragments derived from
polyclonal antibodies to specific antigens obtained from equine
plasma.
About SAB BiotherapeuticsSAB 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.
About Emergent BioSolutionsAt Emergent, our
mission is to protect and enhance life. For over 20 years, we’ve
been at work defending people from things we hope will never
happen—so we are prepared just in case they ever do. We provide
solutions for complex and urgent public health threats through a
portfolio of vaccines and therapeutics that we develop and
manufacture for governments and consumers. We also offer a range of
integrated contract development and manufacturing services for
pharmaceutical and biotechnology customers. To learn more about how
we plan to protect or enhance 1 billion lives by 2030, visit
our website and follow us on LinkedIn, Twitter,
and Instagram.
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-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
SAB Biotherapeutics:
Investor Relations:SABIR@westwicke.com
Media Relations:SABPR@westwicke.com
Emergent BioSolutions:
Investor ContactRobert BurrowsVice President,
Investor Relationsburrowsr@ebsi.com(240) 413-1917Media
ContactMatt HartwigSenior Director, Media
Relationsmediarelations@ebsi.com
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