Inovio Pharmaceutical's DNA Vaccine for Zika Virus Induces Robust Immune Responses in Preclinical Study
February 17 2016 - 7:00AM
Biotech begins clinical
manufacturing; expects to test Zika vaccine
in humans in 2016
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that
preclinical testing of its synthetic vaccine for the Zika virus
induced robust and durable immune responses, demonstrating the
potential for a SynCon® vaccine to prevent and treat infections
from this harmful pathogen. Health authorities have observed
neurological and autoimmune complications potentially associated
with Zika virus, including microcephaly in newborns and
Guillain-Barre syndrome. Inovio is developing its Zika vaccine with
GeneOne Life Sciences (KSE:011000) and academic collaborators.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "Using our SynCon® technology we rapidly generated a
synthetic vaccine candidate that shows promise as a preventive and
treatment. With robust antibody and killer T cell responses
generated by our vaccine in mice, we will next test the vaccine in
non-human primates and initiate clinical product manufacturing. We
plan to initiate phase I human testing of our Zika vaccine before
the end of 2016."
In this pre-clinical study, DNA vaccine
constructs targeting multiple Zika virus antigens were
synthetically generated using Inovio's SynCon vaccine technology.
These SynCon constructs were administered using Inovio's CELLECTRA®
electroporation delivery technology. Inovio's Zika DNA vaccine
resulted in seroconversion, or the development of detectable
specific antibodies in the blood, in all vaccinated mice.
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.
Zika virus belongs to the flavivirus family,
which includes dengue and West Nile virus (WNV). Inovio previously
published robust immunogenicity and challenge protection data for
its SynCon dengue and WNV vaccine candidates. Inovio’s Zika program
builds on its extensive previous preclinical development experience
with flavivirus-related vaccines.
About 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 February 2016 WHO stated that 39 countries had
reported locally acquired circulation of the Zika virus since
January 2007. 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 GeneOne Life Science
GeneOne Life Science Inc. is an international
DNA vaccine developer and leading contract manufacturer of DNA
plasmid-based agents for preclinical and clinical trials for global
companies and institutions. It researches and develops DNA vaccines
to prevent and treat incurable diseases in South Korea and
internationally. The company is headquartered in Seoul, South
Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary
located in Texas, is the largest pure-play cGMP DNA plasmid
manufacturing facility in the world.
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. The company is advancing a growing
clinical and preclinical stage product pipeline. Partners and
collaborators include MedImmune, Roche, 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 immune therapy and vaccine
products, our ability to advance our portfolio of immune-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, 2014,
our Form 10-Q for the quarter ended September 30, 2015, 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.
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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