ROCKVILLE, Md. and GERMANTOWN, Md., Dec.
9, 2013 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE
MKT: SYN), a developer of product candidates focused on the
prevention and treatment of serious infectious diseases and other
diseases, and Intrexon Corporation (NYSE: XON) ("Intrexon"), a
leader in synthetic biology, announced today that they have
initiated development of novel biologic approaches for the
prevention, as well as the acute and chronic treatment of a subset
of irritable bowel syndrome (IBS) pathologies specifically caused
by auto-antibodies.
Synthetic Biologics intends to utilize intellectual property
optioned from Cedars-Sinai Medical Center ("Cedars-Sinai").
According to an increasing body of recent work conducted by
Cedars-Sinai, a subset of IBS cases appear to be causally initiated
by one or more encounters with acute infectious gastroenteritis,
such as the foodborne illness, Campylobacter jejuni.
Cedars-Sinai has identified a novel autoimmune target for this
subset of IBS cases because of the development of cross-reacting
antibodies between a bacterial toxin and a protein important for
controlling gastrointestinal motility.
"We are thrilled to begin work with Intrexon for the development
of novel biologic therapeutics targeted at preventing and treating
auto-antibody-induced IBS. By accessing Intrexon's proprietary
technologies and capabilities, we will pursue development of a
vaccine against the bacterial toxin, which does not yield cross
reactivity with the gastrointestinal motility protein.
Additionally, we will pursue novel approaches to treat acute
exposure of the bacterial toxin, as well as block the activity of
the auto-antibodies," said Jeffrey
Riley, Chief Executive Officer of Synthetic Biologics,
Inc.
Samuel Broder, M.D., Senior Vice
President of Intrexon's Health sector and former Director of the
National Cancer Institute stated, "Existing IBS therapies, which
are primarily focused on supportive care, are unlikely to address
the treatment needs of the patient population with auto-antibodies,
an underlying immune-specific pathology. This new collaboration
represents an important opportunity to address the unmet medical
need in these patients with personalized medicine. The
collaboration will target the root causes of a subset of irritable
bowel syndrome-associated pathologies, and could have a significant
impact on the prevention and therapy of this serious disorder."
The initiation of biologic development for the prevention and
treatment of both forms of IBS is the third pathogen-specific
indication Synthetic Biologics intends to pursue as part of its
August 2012 worldwide exclusive
channel collaboration with Intrexon. Under this collaboration, the
Company intends to utilize Intrexon's comprehensive suite of
proprietary technologies, including their extensive Protein
Engineering assets, mAbLogix™, and LEAP™ platforms, to develop
biologics to specifically and rapidly neutralize/clear pathogens
that cause serious infectious diseases and other diseases. The
first two target indications under the Intrexon collaboration
continue to make well-paced progress. The development of a
monoclonal antibody (mAb) therapy to treat life-threatening
whooping cough (Pertussis) is expected to initiate an IND-enabling
study during the first quarter of 2014. The generation of a panel
of antibodies to target the multidrug-resistant pathogen,
Acinetobacter, is ongoing. While Synthetic Biologics has
initiated development of the initial three targets, the Intrexon
collaboration may optionally be expanded to include up to a total
of eight pathogen-specific indications.
About Synthetic Biologics, Inc.
Synthetic Biologics,
Inc. (NYSE MKT: SYN) is a biotechnology company focused on the
development of product candidates for serious infectious diseases
and other diseases. Synthetic Biologics is developing oral
treatments targeting archaea, a non-bacterial intestinal form of
life increasingly associated with chronic diseases such as
irritable bowel syndrome (IBS), obesity and type 2 diabetes, an
oral biologic to protect the gastrointestinal microflora from the
effects of IV antibiotics for the prevention of C. diff
infection, a series of monoclonal antibodies (mAbs) for the
treatment of Pertussis and Acinetobacter infections, and a
biologic targeted at the prevention and treatment of IBS. In
addition, the Company is developing an oral estriol drug candidate
for the treatment of relapsing-remitting multiple sclerosis (MS)
and cognitive dysfunction in MS (with results of an ongoing 164
subject, 15 center, two-year, double blind, placebo controlled,
Phase II relapsing-remitting MS clinical trial expected to be
announced during the first half of 2014). For more information,
please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
About Intrexon Corporation
Intrexon Corporation (NYSE:
XON) is a leader in synthetic biology focused on collaborating with
companies in Health, Food, Energy and the Environment to create
biologically-based products that improve the quality of life and
the health of the planet. Through the Company's proprietary
UltraVector® platform, Intrexon provides its partners with
industrial-scale design and development of complex biological
systems. The UltraVector® platform delivers unprecedented control
over the quality, function, and performance of living cells. We
call our synthetic biology approach and integrated technologies
Better DNA®, and we invite you to discover more at www.dna.com.
Trademarks: mAbLogix™, LEAP™, UltraVector®, and Better
DNA® are trademarks of Intrexon Corporation.
This release includes forward-looking statements on Synthetic
Biologics' current expectations and projections about future
events. In some cases forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based
upon current beliefs, expectations and assumptions and are subject
to a number of risks and uncertainties, many of which are difficult
to predict and include statements regarding the timeline for the
Pertussis IND-enabling study, Synthetic Biologics' use of
Intrexon's technologies and Cedar-Sinai intellectual property and
the intended results of such use, the impact of the Intrexon
collaboration on the prevention and therapy of certain irritable
bowel syndrome associated pathologies. The forward-looking
statements are subject to risks and uncertainties that could cause
actual results to differ materially from those set forth or implied
by any forward-looking statements. Important factors that could
cause actual results to differ materially from those reflected in
Synthetic Biologics' forward-looking statements include, among
others, a failure of Synthetic Biologics' technologies for the
treatment of infectious diseases and other diseases to be
successfully developed or commercialized, a failure of the
Intrexon's intellectual property to develop the necessary
biologics, an inability to obtain regulatory approval of the
infectious disease and other disease product candidates, a failure
of the results of clinical trials to support the efficacy or safety
of product candidates, a failure of the preclinical or clinical
trials to proceed on schedules that are consistent with Synthetic
Biologics' current expectations or at all, Synthetic Biologics'
inability to protect its intellectual property and freedom to
operate without interference of the patents of others, inability to
maintain the effectiveness of the exclusive collaboration
agreement, its reliance on third parties to develop its product
candidates, the insufficiency of existing capital reserves to fund
continued operations for a particular amount of time and
uncertainties regarding Synthetic Biologics' ability to obtain
additional financing to support its operations thereafter and other
factors described in Synthetic Biologics' report on Form 10-K for
the year ended December 31, 2012 and
any other filings with the SEC. The information in this release is
provided only as of the date of this release, and Synthetic
Biologics undertakes no obligation to update any forward-looking
statements contained in this release on account of new information,
future events, or otherwise, except as required by law.
SOURCE Synthetic Biologics, Inc.