Inovio Initiates Clinical Trial With DNA Immunotherapies to Prevent and Treat Ebola
May 12 2015 - 5:00AM
Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today that the
company has initiated a phase I trial to evaluate safety,
tolerability and immune responses of Inovio's DNA immunotherapy for
Ebola. In previously published preclinical testing, Inovio's
DNA-based Ebola immunotherapy protected 100% of immunized animals
from death and sickness after being exposed to a lethal dose of the
Ebola virus.
This is the first step in the Inovio-led consortium selected by
the U.S. Defense Advanced Research Projects Agency (DARPA) to take
a multi-faceted approach to develop products to both prevent and
treat Ebola infection. These programs include development and early
clinical testing of:
- Inovio's DNA-based vaccine against Ebola, for which the first
study was initiated this week.
- Inovio's therapeutic DNA-based monoclonal antibody product
dMAb™ against Ebola virus infection. This promising new technology
has properties that are best suited to respond to an Ebola outbreak
in that they could be designed and manufactured expediently on a
large scale using proven fermentation technology, are
thermal-stable, and may provide more rapid therapeutic benefit;
and
- A highly potent conventional protein-based therapeutic
monoclonal antibody (mAb) product against Ebola virus
infection.
This initial trial will evaluate Inovio's Ebola immunotherapy
(INO-4212) in five groups of healthy subjects receiving INO-4212
and its components (INO-4201 and INO-4202) alone or in combination
with INO-9012, delivered into muscle or skin using Inovio's
proprietary DNA delivery technology.
Dr. J. Joseph Kim, President and CEO, said, "The Inovio-led
partnership is uniquely positioned to create and test methods to
both prevent and treat Ebola virus infections. The global product
development experts we have brought together coupled with Inovio's
DNA-based vaccines and immunotherapies should meet and exceed the
expected outcomes. Demonstrating our commitment and speed, we have
begun our first trial just a few weeks after being selected by
DARPA to advance this promising program."
About the Ebola Virus
The Ebola virus causes periodic outbreaks of a highly contagious
and lethal human infectious disease marked by severe hemorrhagic
fever, with a mortality rate that ranges between 50% and 90%. The
infection typically affects multiple organs in the body and is
often accompanied by severe bleeding. The virus is transmitted to
people from wild animals and spreads in the human population
through human-to-human transmission. At present, there are no
FDA-approved pre- or post-exposure interventions available in the
event of an outbreak, laboratory accident, or deliberate misuse.
The Ebola virus is classified as a Category A Priority Pathogen by
the Centers for Disease Control and Prevention. This designation
prescribes an accelerated development pathway for FDA approval that
determines efficacy based on two different validated animal studies
followed by clinical evaluation in phase I and phase II trials to
establish safety and immunogenicity for use in humans.
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 immune therapies, the
company is advancing a growing preclinical and clinical stage
product pipeline. Partners and collaborators include Roche,
MedImmune, 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, including INO-5150, and
to commence a phase I clinical trial for INO-5150 in the first half
of 2015, 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 March 31, 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.
CONTACT: Investors:
Bernie Hertel
Inovio Pharmaceuticals
858-410-3101
bhertel@inovio.com
Media:
Jeff Richardson
Inovio Pharmaceuticals
267-440-4211
jrichardson@inovio.com
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Sep 2023 to Sep 2024