Inovio and Partner Advance MERS Vaccine
19 October 2015 - 11:00PM
Inovio Affiliate GeneOne Files
Investigational New Drug Application
GeneOne Life Science Inc. (KSE:011000), which partnered with Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) to develop Inovio’s MERS
vaccine (GLS-5300), today announced the filing of an
Investigational New Drug Application (IND) for GLS-5300 with the
United States Food and Drug Administration. The companies expect to
move the MERS vaccine into a phase I clinical trial in healthy
volunteers before year end.
Middle East respiratory syndrome (MERS) is
caused by a coronavirus that is related to the severe acute
respiratory syndrome (SARS) virus that over 10 years ago infected
over 8,000 people, with a 10% death rate. There is no vaccine or
effective treatment against MERS, which spreads from human to
human. Since 2012, MERS has infected over 1,500 people and killed
almost 600 (40%). Recently, the largest outbreak outside of Saudi
Arabia of this emergent global health concern infected 186 people
with 36 fatalities in South Korea.
Earlier this year, Inovio’s MERS vaccine induced
100% protection from a live virus challenge in a preclinical study.
Inovio and its collaborators evaluated its MERS vaccine in mice,
camels and monkeys, or non-human primates. As published in Science
Translational Medicine, the vaccine induced robust immune responses
capable of preventing the virus from infecting cells in all three
species. In monkeys, all vaccinated animals in the study were
protected from symptoms of MERS when challenged with a live MERS
virus.
Dr. J. Joseph Kim, President and CEO, said, “We
are moving rapidly from achieving complete protection from MERS in
monkey studies to our goals of obtaining safety data from a phase I
trial and regulatory approval.”
About GeneOne Life Science
GeneOne Life Science Inc. is an international
DNA vaccine developer and leading contract manufacturer of DNA
plasmid-based agents for pre-clinical 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. Inovio holds an equity
interest in GeneOne.
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 is 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, 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, 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 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 June 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.
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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