PLYMOUTH MEETING, Pa.,
Sept. 24, 2014 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced it
will advance its DNA vaccine for Ebola into a phase I clinical
trial in a collaboration with GeneOne Life Science Inc. (KSE:
011000), an international DNA vaccine manufacturer in which Inovio
holds a minority interest.
In the collaboration Inovio and GeneOne will co-develop Inovio's
DNA-based Ebola vaccine through a phase I clinical trial. The
companies are currently conducting pre-IND activities and plan to
start the clinical study in the first half of 2015. Upon successful
completion of the phase I, the companies will jointly seek
additional third party support and resources to further develop and
commercialize this product.
Along with the escalating spread of Ebola and related deaths,
this virus is also mutating into diverse strains. There are no
preventive vaccines or effective therapeutic approaches to Ebola;
the ease with which Ebola is generating genetic variations will
complicate the process of creating such solutions. In addition,
various experimental approaches have already been associated with
undesirable side effects and limited ability to scale
manufacturing.
Inovio's SynCon® technology has been the basis for
immunotherapy and vaccine products which have demonstrated the
ability to activate immune responses against multiple
disease-specific antigens and elicit broad protection against
diverse unmatched strains of pathogens in humans. These DNA-based
immunotherapy products have demonstrated a very favorable safety
profile. Furthermore, these synthetic immunotherapies are
manufactured using established production processes. Inovio's Ebola
vaccine was designed using the SynCon technology to provide broad
protective antibody and T-cell responses against multiple strains
of Ebola virus.
In published preclinical testing of its Ebola vaccine, Inovio
observed that 100% of vaccinated guinea pigs and mice were
protected from death after being exposed to the Ebola virus. Unlike
the non-vaccinated animals, vaccinated animals were also protected
from weight loss, a measure of morbidity. Researchers found
significant increases in neutralizing antibody titers and strong
and broad levels of vaccine-induced T-cells, including "killer"
T-cells, suggesting that this product could provide both preventive
and treatment benefits.
Dr. J. Joseph Kim, President and
CEO, said, "Inovio's SynCon® DNA-based immunotherapy and
vaccine technology offers an advantageous set of characteristics
and capabilities to generate and direct powerful immune responses
against a target disease. There are no proven agents to check the
spread of Ebola, which is now becoming a health threat of global
concern. We are therefore taking the steps with our collaborator to
establish the safety and immunogenicity of our Ebola vaccine in
humans and be in a position to further advance these agents to help
fight this challenging disease."
About Ebola
More than 2,622 people have died in the worst outbreak of Ebola
virus in history, which has so far infected at least 5,335 people
in West Africa, according to the
World Health Organization (WHO). In a recent update on the
epidemic, which is raging through Guinea, Sierra
Leone and Liberia and has
spread into Nigeria and
Senegal, the WHO said there were
no signs yet of it slowing. There is no vaccine or standard of care
treatment for people infected with the Ebola virus.
About GeneOne
GeneOne Life Science Inc. is a leading contract manufacturer of
DNA plasmid based agents for pre-clinical and clinical trials for
global companies and institutions. In addition, 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.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and
infectious diseases. Our immunotherapies uniquely activate
best-in-class immune responses to prevent and treat disease, and
have shown clinically significant efficacy with a favorable safety
profile. With an expanding portfolio of cancer immunotherapies and
clinical studies, the company is advancing a growing product
pipeline. Partners and collaborators include Roche,
the University of Pennsylvania, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, US Dept. of Homeland Security, 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 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, 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, 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, 2013, our Form 10-Q for the
quarter ended June 30, 2014, 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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SOURCE Inovio Pharmaceuticals, Inc.