Synthetic Biologics and Intrexon Corporation Initiate Development
of Monoclonal Antibodies for Whooping Cough (Pertussis)
ROCKVILLE, Md. and
SAN FRANCISCO, Dec. 20, 2012
/PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a
developer of synthetic biologics and innovative medicines for
serious infections and diseases, and Intrexon Corporation, a
leading synthetic biology company that utilizes its proprietary
technologies to provide control over cellular function, announced
today that they have initiated development of a monoclonal antibody
(mAb) therapy for the treatment of pertussis, more commonly known
as whooping cough. Each year, Bordetella pertussis (B.
pertussis) infection causes an estimated 294,000 deaths
worldwide, primarily among young, unvaccinated
children.1 Recent reports indicate that the pertussis
vaccine introduced in the 1990s does not provide long-term
protection and, as a result, whooping cough cases are increasing to
a 60-year high in the U.S.2,3 To aid in the management
of the rising number of pertussis cases, Synthetic Biologics
intends to develop a mAb therapy, SYN-005, designed to neutralize
the pertussis toxin, thereby reducing the mortality rate in infants
and potentially shortening the chronic cough in adults.
The initiation of mAb development for the treatment of pertussis
is the second of three infectious disease indications Synthetic
Biologics intends to pursue as part of its August 2012 collaboration with Intrexon. To
further the development of this potential therapy for pertussis,
Synthetic Biologics has entered into an agreement with The
University of Texas at Austin to
license the rights to certain research and pending patents related
to pertussis antibodies. These research efforts are being conducted
at the Cockrell School of Engineering in the laboratory of
Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E.
McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of
Chemical Engineering. Dr. Maynard brings to the project her
expertise in defining the key neutralizing epitopes of pertussis
toxin to optimize the potential efficacy of antibody
therapeutics.
Dr. Maynard stated, "I am very excited to be working with
Synthetic Biologics on the development of this important new
treatment for whooping cough, with the potential to protect infants
from this devastating disease, and to treat adults who suffer from
the disease later in life."
B. pertussis is a gram-negative bacterium that infects
the respiratory tract of humans, causing uncontrollable, violent
coughing. Antibiotic treatment does not have a major effect on the
course of pertussis, because while it can eliminate the B.
pertussis bacteria from the respiratory tract, it does not
neutralize the pertussis toxin. Infants with pertussis often
require hospitalization in pediatric intensive care units,
frequently necessitating mechanical ventilation. Pertussis in
adults generally leads to a chronic cough referred to as the "cough
of 100 days." The increased incidence of pertussis is associated
with exposure of unvaccinated and under-vaccinated individuals,
especially infants who are not yet fully vaccinated and individuals
whose immunity has diminished over time, as well as individuals who
are carriers with bacteria present in their lungs but may or may
not have the active disease. Unlike antibiotics, SYN-005 will be
designed to neutralize the pertussis toxin and reverse the course
of the disease.
"We are pleased to begin work on a mAb therapy to treat
pertussis with our infectious disease collaborator, Intrexon, as
well as with the experts at The University of
Texas at Austin. Dr. Maynard has been researching and
developing specific pertussis toxin targets for more than five
years and her experience should accelerate our development
timelines," said Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics, Inc. "A steady
increase in outbreaks of pertussis has become a serious threat to
some of the most vulnerable members of our society, especially
infants, and to individuals who are unvaccinated or whose vaccine
failed to provide lasting immunity. Across the nation this year,
doctors have reported twice as many cases of pertussis as there
were in 2011. The risk to individuals and to public health caused
by outbreaks of pertussis support the pursuit of a new therapeutic
option such as our mAb therapy."
Collaboration with Intrexon
In August 2012, Synthetic
Biologics entered into a worldwide exclusive channel collaboration
with Intrexon for the development and commercialization of mAb
therapies to treat certain infectious diseases. Under this
collaboration, the Company intends to utilize Intrexon's
comprehensive suite of proprietary technologies, including the
mAbLogix™ and LEAP™ platforms, to develop mAbs to specifically and
rapidly neutralize/clear pathogens that cause infectious diseases.
While the Synthetic Biologics has initiated mAb development for two
of three initial targets, Acinetobacter infection and
pertussis, the collaboration may optionally be expanded to include
up to a total of eight infectious disease indications.
About Monoclonal Antibodies (mAbs)
Acting as the body's army, antibodies are proteins, generally
found in the bloodstream, that provide immunity in detecting and
destroying pathogens, such as viruses, bacteria and toxins. MAbs
can be designed and produced as therapeutic agents, utilizing
protein engineering and recombinant production technologies. The
mAbs being developed under the Synthetic Biologics' collaboration
with Intrexon are intended to supplement a patient's own immune
system by providing the means to specifically and rapidly
neutralize and/or clear specific pathogens and toxins of interest
in a process known as "passive immunity." Many pathogens that cause
infectious diseases are innately resistant to, or over time have
developed increased resistance to, antibiotics and other drugs.
Synthetic Biologics intends to utilize Intrexon's comprehensive
suite of proprietary mAb design and recombinant protein production
technologies to efficiently create a potent candidate mAb (SYN-005)
for human testing and use to specifically treat pertussis.
About Intrexon Corporation
Intrexon Corporation is a privately held biotechnology company
focused on the industrial engineering of synthetic biology.
Intrexon is deploying its extensive capabilities to rapidly design
and produce novel and enhanced biological products and processes
across multiple industry sectors, including: human therapeutics,
protein production, industrial products, agricultural
biotechnology, and animal science. The Company's advanced
bioindustrial engineering platform enables Better DNA™ technology
by combining revolutionary DNA control systems with corresponding
advancements in modular transgene design, assembly, and
optimization to enable unprecedented control over the function and
output of living cells. More information about the Company is
available at www.dna.com.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of product candidates for serious infections and
diseases. Synthetic Biologics is developing a biologic for the
prevention of C. diff infection, and a series of monoclonal
antibodies (mAbs) for the treatment of serious infectious diseases,
including Acinetobacter and pertussis. The Company is also
developing a synthetic DNA-based therapy for the treatment of
pulmonary arterial hypertension (PAH) in collaboration with
Intrexon. In addition, the Company is developing a drug candidate
for the treatment of relapsing-remitting multiple sclerosis (MS)
and cognitive dysfunction in MS, and designing a clinical
development pathway for the treatment of amyotrophic lateral
sclerosis (ALS). For more information, please visit Synthetic
Biologics' website at www.syntheticbiologics.com.
mAbLogix™ and LEAP™ are registered 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 Synthetic Biologics'
intent to develop and commercialize multiclonal antibody therapies
for the treatment of infectious diseases such as pertussis, the
timeline for such development, its use of Intrexon's technologies
and the intended results of such use, the opportunity presented by
the number of affected patients, the anticipated results to be
derived from the mAb research conducted at The University of Texas at Austin and the potential
expansion of the Intrexon collaboration. 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' monoclonal antibodies for
the treatment of infectious diseases to be successfully developed
or commercialized, a failure of the Intrexon's intellectual
property to create potent candidate mAbs, an inability to obtain
regulatory approval of the infectious 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/A for the year ended December 31,
2011 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.
[1] World Health Organization. Pertussis: immunization
surveillance, assessment and monitoring.
http://www.who.int/immunization_monitoring/diseases/pertussis/en/index.html.
[2] Misegades LK, Winter K, Harriman K, Talarico J, Messonnier
NE, Clark TA, Martin SW, Association of childhood pertussis with
receipt of 5 doses of pertussis vaccine by time since last vaccine
dose, California, 2010. JAMA, 2012
Nov 28;308(20):2126-32.
[3] Centers for Disease Control and Prevention. Pertussis
Epidemic – Washington, 2012.
Morbidity and Mortality Weekly Report. July
20, 2012.
SOURCE Synthetic Biologics, Inc.