Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that
testing of its synthetic vaccine for the Zika virus induced robust
antibody and T cell responses in non-human primates (monkeys),
demonstrating the product’s potential to prevent infection from
this harmful pathogen.
Inovio synthetically generated DNA vaccine
constructs targeting multiple Zika virus antigens using its SynCon
vaccine technology. These SynCon constructs were administered using
Inovio's CELLECTRA® electroporation delivery technology. Two doses
of the Zika DNA vaccine delivered either intramuscularly or
intradermally resulted in seroconversion, or the development of
detectable specific antibodies in the blood, in all vaccinated
non-human primates. Researchers also observed that vaccination
generated robust and broad T cell responses as analyzed by the
standardized T cell ELISPOT assay. These findings are vital given
the potential 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 & CEO,
said, “With positive large animal results in hand we are moving
aggressively to initiate and conduct our first Zika vaccine human
trial in 2016.”
Dr. Kim will discuss Inovio’s Zika vaccine
preclinical developments today at an international forum hosted and
organized by the Foundation for Vaccine Research and The National
Academy of Medicine called “Ebola, SARS, MERS, Nipah, Zika Virus
and Beyond: Challenges and Opportunities for Vaccine Development”
in Washington DC. This high-level international forum is an
invitation-only 1½ day event for decision-makers from the public
and private sectors.
Inovio is developing its Zika vaccine, GLS-5700,
with GeneOne Life Sciences (KSE:011000) and academic collaborators
with whom Inovio has previously collaborated to advance its
vaccines for Ebola and MERS into clinical development.
About the Zika Virus
First identified in Uganda, Zika virus subsequently spread to
equatorial Asia and over the past two years has rapidly spread
through the South Pacific, including Hawaii, and to South America,
Central America, and the Caribbean. Zika virus is a flavivirus, a
family of viruses including yellow fever, dengue, and West Nile
virus, which are introduced to people through mosquito bites.
Because the Aedes species of mosquitoes that spread Zika virus is
found throughout the world there is concern that outbreaks will
spread to new countries. There is also concern that Zika can spread
sexually, as has been reported for some returning travelers. In
May, 2016, WHO stated that 58 countries and territories report
continuing mosquito-borne transmission of Zika. Geographical
distribution of the virus has steadily expanded.
The most common symptoms of Zika virus are
fever, rash, joint pain, and conjunctivitis. More seriously, a
possible link to a severe birth defect called microcephaly has
recently been observed resulting from infected mothers.
Microcephaly is a rare condition marked by an abnormally small head
and incomplete brain development. There may also be a link with
Guillain-Barré syndrome, a disease in which the body's immune
system mistakenly attacks peripheral nerves. Symptoms start with
muscle weakness. In severe cases the person is almost totally
paralyzed and the disorder can be life threatening.
No vaccine or therapy currently exists for the
Zika virus.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, Roche, The Wistar Institute, University of Pennsylvania,
DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines
Trial Network, National Cancer Institute, U.S. Military HIV
Research Program, and University of Manitoba. For more information,
visit 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, our expectations regarding our
research and development programs 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, including safety and efficacy for
VGX-3100 and INO-3112, 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, our ability to support
our broad pipeline of SynCon® active immunotherapy and vaccine
products, our ability to advance our portfolio of immuno-oncology
products independently, the ability of our collaborators to attain
development and commercial milestones for products we license and
product sales that will enable us to receive future payments and
royalties, 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, our ability to enter into
partnerships in conjunction with our research and development
programs, 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, 2015,
our Form 10-Q for the quarter ended March 31, 2016, 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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