Inovio Pharmaceuticals and GeneOne Life Science Initiate Patient Recruitment for MERS Vaccine Trial
January 28 2016 - 7:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the
beginning of recruitment for its collaborative vaccine study for
MERS (Middle East Respiratory Syndrome). Inovio and GeneOne Life
Science Inc. (KSE:011000) are co-developing Inovio’s MERS vaccine
(GLS-5300) in partnership with the Walter Reed Army Institute of
Research (WRAIR) in Maryland, where the trial is being conducted.
The primary and secondary goals of this
first-in-man phase I trial are to obtain safety and immunogenicity
data. This trial represents the first MERS vaccine to be tested in
humans for this disease that has no approved vaccines or
treatments.
Dr. J. Joseph Kim, Inovio President and CEO,
said, “After partnering with WRAIR and receiving an IND approval
from the FDA late last year, we are pleased to now open this trial
with our collaborators. The MERS virus has triggered widespread
outbreaks and deaths in the Middle East and Korea and the
healthcare community is urgently exploring possible preventive and
therapeutic solutions.
“Our broad experience with DNA-based
immunotherapies and with MERS specifically suggests we can
potentially make an important contribution to developing such a
solution. As demonstrated by our recent vaccine development efforts
for Ebola, we can readily apply Inovio’s technology to target other
threatening infectious threats like MERS and Zika virus as well as
other emergent infectious diseases.”
Last year, GLS-5300 induced 100% protection from
a live virus challenge in a rhesus macaque non-human primate study.
Inovio and its collaborators evaluated its MERS vaccine in mice,
camels as well as 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.
Middle East Respiratory Syndrome is caused by a
coronavirus that is related to the severe acute respiratory
syndrome (SARS). While SARS infected more than 8,000 people, the
disease was short-lived between 2002 and 2004 and had a mortality
rate of about 10%. Since 2012, MERS has infected over 1,600 people,
with almost 600 deaths, a mortality rate of about 40%, and is still
ongoing. Highlighting the global concern for MERS, in the summer of
2015 a single business person returned to South Korea from Saudi
Arabia and was the index case for a country-wide epidemic involving
186 persons with a 20% mortality rate.
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.
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.
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.
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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