BLUE BELL, Pa., May 27, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that its
novel DNA-based therapeutic monoclonal antibody targeting
Chikungunya virus (CHIKV) completely protected mice from a lethal
CHIKV challenge. In this preclinical study, a prototype DNA plasmid
construct encoding for a monoclonal antibody for CHIKV envelope
protein was created using Inovio's patented DNA optimization
technology and delivered with its CELLECTRA® device. The
results were presented as a poster at the 17th Annual Meeting of
the American Society of Gene & Cell Therapy in Washington, DC.
Chikungunya virus (CHIKV) has re-emerged as a serious
mosquito-borne alpha-virus responsible for several recent epidemics
in tropical Africa and
Asia. Recent evidence suggests
that CHIKV, which is primarily transmitted to humans from
mosquitoes, could spread to other parts of the world. There
is no vaccine or therapeutic against this virus.
In this presented study, Inovio scientists and collaborators
developed a novel DNA plasmid encoding a highly engineered
immunoglobulin encoding a CHIKV monoclonal antibody (mAb) to
directly generate in vivo production of an anti-CHIKV mAb in mice.
They demonstrated that the serum of transfected animals exhibited
the specific ability to bind to the CHIKV envelope antigen and this
serum possessed CHIKV-neutralizing activity. Importantly, the
treatment of the animals with anti-CHIKV mAb plasmids protected
100% of the treated animals from a lethal injection of CHIKV virus
while 100% of the control animals died. The treated animals were
also spared of virus-related morbidity, as measured by dramatic
weight loss and lethargy.
Monoclonal antibodies (mAb) were a transformational scientific
innovation designed to enhance the immune system's ability to
regulate cell functions. They are designed to bind to a very
specific epitope (area) of an antigen or cell surface target and
can bind to almost any selected target. mAbs have the unique
ability to alert the immune system to attack and kill specific
cancer cells (as in the case of Yervoy®) or block certain
biochemical pathways (such as those leading to rheumatoid
arthritis, as in the case of Remicade®). However, mAb technology
has limitations. Delivered by passive administration, meaning they
are manufactured outside the body, mAbs typically require costly
large-scale laboratory development and production. Additional
limitations include the necessity for repeat administrations and
their limited duration of in vivo potency.
The paradigm shift of Inovio's technology is that the DNA for a
monoclonal antibody is encoded in a DNA plasmid, delivered directly
into cells of the body using electroporation, and the mAbs are
"manufactured" by these cells. Using this patent-protected
approach, Inovio previously published that a single administration
of a highly optimized DNA-based monoclonal antibody targeting HIV
virus in mice generated antibody molecules in the bloodstream
possessing desirable functional activity including high
antigen-binding and HIV-neutralization capabilities against diverse
strains of HIV viruses. This new work further demonstrates the
capability of this technology using a CHIKV challenge
model.
All of these feats were not previously achievable with other
DNA-based or viral delivery technologies. Inovio's transformational
approach could be applied to develop active monoclonal antibody
products against multiple therapeutically important diseases
including cancers as well as inflammatory and infectious diseases.
Combined with the significantly favorable cost structure of
Inovio's DNA-based technology in comparison to conventional
monoclonal antibody technology, active in-body generation of
functional monoclonal antibodies in humans has the potential to
significantly expand the range of targetable diseases.
"Inovio continues to demonstrate that it is one of the most
innovative and scientifically productive biotechnology companies in
our industry," stated Dr. J. Joseph
Kim, President and CEO. "We have again shown that we can
design a novel mAb construct capable of providing therapeutic
benefit and are confident we can create DNA-based monoclonal
antibodies against any infectious disease or cancer. These
advancements represent a new area of value enhancement for Inovio
stakeholders and we plan to develop multiple important monoclonal
product candidates, alone or with new partners."
Monoclonal antibodies have become one of the most valuable
therapeutic technologies of recent years. In 2012, global sales
value of monoclonal antibodies exceeded $50
billion. Among the top 10 best-selling drugs in 2012, six of
them were monoclonal antibodies, each with annual sales exceeding
$5 billion.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's
cancers and challenging infectious diseases. Its SynCon®
vaccines, in combination with its proprietary electroporation
delivery, are generating best-in-class immune responses, with
therapeutic T-cell responses exceeding other technologies in terms
of magnitude, breadth, and response rate. Human data to date have
shown a favorable safety profile. Inovio's lead vaccine, a
therapeutic against HPV-caused pre-cancers and cancers, is in phase
II. Other phase I and preclinical programs target prostate, breast,
and lung cancers as well as HIV, influenza, malaria and hepatitis.
Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, US Dept. of Homeland Security, and University of Manitoba. More information is
available at www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines and our capital resources. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in pre-clinical
studies, clinical trials and product development programs
(including, but not limited to, the fact that pre-clinical and
clinical results referenced in this release may not be indicative
of results achievable in other trials or for other indications,
that the studies or trials may not be successful or achieve the
results desired, that pre-clinical studies and clinical trials may
not commence or be completed in the time periods anticipated, that
results from one study may not necessarily be reflected or
supported by the results of other similar studies and that results
from an animal study may not be indicative of results achievable in
human studies), the availability of funding to support continuing
research and studies in an effort to prove safety and efficacy of
electroporation technology as a delivery mechanism or develop
viable DNA vaccines, the adequacy of our capital resources, the
availability or potential availability of alternative therapies or
treatments for the conditions targeted by the company or its
collaborators, including alternatives that may be more efficacious
or cost-effective than any therapy or treatment that the company
and its collaborators hope to develop, evaluation of potential
opportunities, issues involving product liability, issues involving
patents and whether they or licenses to them will provide the
company with meaningful protection from others using the covered
technologies, whether such proprietary rights are enforceable or
defensible or infringe or allegedly infringe on rights of others or
can withstand claims of invalidity and whether the company can
finance or devote other significant resources that may be necessary
to prosecute, protect or defend them, the level of corporate
expenditures, assessments of the company's technology by potential
corporate or other partners or collaborators, capital market
conditions, the impact of government healthcare proposals and other
factors set forth in our Annual Report on Form 10-K for the
year ended December 31, 2013, our Form 10-Q for the quarter
ended March 31, 2014, and other
regulatory filings from time to time. There can be no assurance
that any product in Inovio's pipeline will be successfully
developed or manufactured, that final results of clinical studies
will be supportive of regulatory approvals required to market
licensed products, or that any of the forward-looking information
provided herein will be proven accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio
Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211,
jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.