Inovio Pharmaceuticals, Inc. (NASDAQ:INO) and GeneOne Life Science,
Inc. (KSE:011000) today announced that they have received approval
to initiate a phase I human trial to evaluate Inovio’s Zika DNA
vaccine (GLS-5700) to prevent infection from this concerning virus.
In preclinical testing this synthetic vaccine induced robust
antibody and T cell responses in small and large animal models,
demonstrating the product’s potential to prevent infection from
this harmful pathogen in humans.
This phase I, open-label, dose-ranging study
with 40 healthy subjects will evaluate the safety, tolerability and
immunogenicity of GLS-5700 administered intradermally with
CELLECTRA®, Inovio’s proprietary DNA delivery device.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “We are proud to have attained the approval to initiate the
first Zika vaccine study in human volunteers. As of May 2016, 58
countries and territories reported continuing mosquito-borne
transmission of the Zika virus; the incidences of viral infection
and medical conditions caused by the virus are expanding, not
contracting. We plan to dose our first subjects in the next weeks
and expect to report phase I interim results later this year.”
Mr. Young K. Park, GeneOne Life Science’s
President & CEO, said, “It is an honor for our company to help
usher this Zika vaccine through the clinical and regulatory
process. We look forward to conducting this trial with the goal of
achieving products to combat this dreaded virus.”
Inovio and GeneOne are developing the Zika
vaccine, GLS-5700, with academic collaborators from the US and
Canada with whom they have previously collaborated to advance
Inovio’s Ebola and MERS vaccines 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
spreads Zika virus is found throughout the world there is concern
that Zika will continue to spread to new countries and regions.
Zika can also be sexually transmitted.
The most common symptoms of Zika virus are
fever, rash, joint pain, and conjunctivitis. More seriously, Zika
has been linked to a severe birth defect called microcephaly which
arises from infection during pregnancy. Microcephaly is a rare
condition marked by an abnormally small head and incomplete brain
development. Zika is also associated with Guillain-Barré syndrome,
which causes muscle weakness of the limbs and in severe cases may
cause almost total paralysis including the inability to breath.
Recent reports suggest Zika may also be linked to other
neurological abnormalities.
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. VGXI manufactured the Zika
vaccine and other emerging disease vaccines including Ebola and
MERS.
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, Plumbline Life Sciences, 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:
Investor and Media Relations:
Bernie Hertel, Inovio Pharmaceuticals, 267-440-4298, investor.relations@inovio.com
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