BLUE BELL, Pa., Nov. 20, 2013 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that
preclinical testing of a DNA synthetic vaccine for the virulent
Middle East Respiratory Syndrome coronavirus (MERS) induced robust
and durable immune responses, demonstrating the potential for a
SynCon® DNA vaccine to prevent and treat this deadly
virus.
Since 2012, when the virus was first identified, 153 cases from
nine Middle Eastern countries have been reported and, alarmingly,
42% of these cases have been fatal. MERS is similar to the SARS
virus which infected 8,000 people several years ago. MERS differs
from SARS in that it appears to be less contagious, but MERS is
almost five times as fatal as SARS, which killed 10% of those
infected. There is no vaccine or effective treatment for MERS.
In this study, DNA vaccine constructs targeting multiple MERS
antigens were generated using Inovio's SynCon® vaccine platform.
These SynCon constructs were administered via Inovio's CELLECTRA®
electroporation-based delivery technology. The vaccine constructs
were observed to induce strong neutralizing antibodies and broad
CD8+ T cells in mice. These findings are vital given the importance
of neutralizing antibodies in preventing infection and the role T
cells play in clearing infection by killing cells that harbor the
virus.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Our SynCon® platform has again
generated a synthetic vaccine candidate that shows promise for
providing a treatment where there is none. With human data showing
the powerful killing effect of T cells generated by our vaccine for
HIV and our therapy for HPV-associated cervical dysplasia and
various cancers, we look forward to providing Inovio's answer to
MERS, a deadly infectious disease that has unknown pandemic
potential. What's even more impressive about our candidate vaccine
is that it is designed with the goal to universally protect against
multiple strains of MERS, which has been shown to have diverse
genetic variants. With appropriate external funding, this product
could become an effective shield against this deadly virus."
To begin the study, a consensus MERS "spike" protein vaccine
construct was created based on multiple strains of the MERS
virus. Inovio's MERS DNA vaccine was immunogenic in mice and
seroconversion, or the development of detectable specific
antibodies in the blood as a result of immunization, was observed
in all animals. Furthermore, the antibodies generated by the
vaccine in 100% of mice (20 of 20) were able to neutralize or
completely block actual infection of MERS virus in the cells,
demonstrating the protective potential of this vaccine. In
contrast, none of the unvaccinated mice in the control group (10)
generated neutralizing antibodies.
Researchers also observed that vaccination was highly T-cell
immunogenic, generating robust and broad T cell responses as
extensively analyzed by the standardized T cell ELISPOT assay. The
vaccine produced robust CD8+ and CD4+ T cell responses against
multiple epitopes of the MERS spike protein. This increased
diversity and magnitude of cellular responses may be critical for
effectively mitigating MERS infection.
About MERS
Middle East Respiratory Syndrome (MERS) is a viral respiratory
illness first reported in Saudi
Arabia in 2012. MERS appears to have been transmitted from
an "animal reservoir" to humans but human to human transmission has
also been confirmed. The virus has not been shown to spread in a
sustained way in communities, but the situation is still evolving.
Like SARS, which infected 8,000 people and was fatal in nearly 10%
of cases, MERS appears to cause a severe lung infection. MERS
differs in that it also causes rapid kidney failure and its
extremely high death rate has caused serious concern among global
health officials.
The World Health Organization has confirmed 153 cases of MERS in
nine countries; 64, or 42%, of these cases have been fatal. All
cases have been directly or indirectly linked through travel to or
residence in four countries: Saudi
Arabia, Qatar, Jordan, and the United Arab Emirates. Experts are still
struggling to understand MERS, for which there is no vaccine. No
cases have been reported in the U.S., but as a precaution, the CDC
has prepared diagnostic kits that have been distributed throughout
the U.S.
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, Merck, NIH, HIV
Vaccines Trial Network, National Cancer Institute, U.S. Military
HIV Research Program, University of Southampton, US Dept. of
Homeland Security, University of
Manitoba and PATH Malaria Vaccine Initiative. 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, 2012, our Form
10-Q for the quarter ended September 30,
2013, 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.