Article in Journal of Infectious Diseases
Supports RationaleFor Inovio’s Ebola Vaccine
Stockpile Program
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that its
Ebola vaccine (INO-4212) provided 100% protection following a
challenge with a lethal dose of the Ebola virus in a preclinical
study. An article in the Journal of Infectious Diseases highlights
that regimens of Inovio’s INO-4212 vaccine delivered by
intramuscular administration provided 100% protection against a
lethal Ebola challenge in all preclinical subjects. Impressively,
just two injections of a simple, dose-sparing intradermal
administration generated strong immunogenicity and provided 100%
protection against a lethal Ebola challenge in a separate study.
Scientists observed that vaccination induced long-term immune
responses in monkeys that were detectable for at least one year
after the final vaccination.
Laurent Humeau, Ph.D., Inovio’s Senior Vice
President R&D, said, “Unlike all other Ebola vaccine candidates
in development, INO-4212 is a vaccine that has shown to be stable
at room temperature for one year. With this new data showing
complete Ebola protection, coupled with impressive Phase 1 results
for immune responses and safety, Inovio is well-positioned to
execute on our overall development strategy in positioning INO-4212
as a viable stockpile vaccine. We are working with collaborators
and potential new funders to advance INO-4212.”
According to the World Health Organization
(WHO), Ebola virus infection causes a severe hemorrhagic fever that
has a more than 50% fatality rate. More than 11,000 people died in
West Africa in a 2014-15 Ebola virus outbreak. Recently, the WHO
reported that the rate of new Ebola cases in the Congo has more
than doubled since September. The current epidemic is the 14th
known outbreak of the Zaire strain of the Ebola virus, known in
epidemiological terms as EBOV. It is the strain with the highest
mortality rate; in most outbreaks, more than 60 percent of those
who come down with the disease die. Recent advances have led to the
development of promising experimental vaccine candidates that may
be associated with side effects and/or may not be applicable in
specific vulnerable populations, such as children, pregnant women
and immunocompromised individuals. In addition, there is a need to
boost these vaccines to provide long-term protection.
In a completed Phase 1 Ebola trial of healthy
participants demonstrated that 95% (170/179) of evaluable subjects
generated an Ebola-specific antibody immune response, with the mean
antibody titer comparable or superior to those reported from viral
vector-based Ebola vaccines. Importantly, Inovio’s Ebola vaccine
was well-tolerated with a favorable safety profile compared to
viral vector-based Ebola vaccines, some of which have been
associated with serious adverse events including myalgia,
arthralgia, fever, and rash. Furthermore, their faster construct
design, ability to continue to boost immune responses and
protection with additional administrations, easier scalability of
manufacturing, and better product thermal stability make DNA
vaccines an attractive platform to rapidly respond to emerging
global infectious diseases.
About Ebola
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 a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio’s proprietary platform technology
applies next-generation antigen sequencing and DNA delivery to
activate potent immune responses to targeted diseases. The
technology functions exclusively in vivo, and has been demonstrated
to consistently activate robust and fully functional T cell and
antibody responses against targeted cancers and pathogens. Inovio
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. Inovio’s most advanced clinical program, VGX-3100, is in
Phase 3 for the treatment of HPV-related cervical pre-cancer. Also
in development are Phase 2 immuno-oncology programs targeting head
and neck cancer, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Wistar Institute,
University of Pennsylvania, Parker Institute for Cancer
Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline Life
Sciences, Drexel University, NIH, HIV Vaccines Trial Network,
National Cancer Institute, U.S. Military HIV Research Program, and
Laval University. 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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, and our plans and expectations regarding
partnerships. 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, 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 pipeline of SynCon® active immunotherapy and vaccine
products, 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 us or our collaborators, including
alternatives that may be more efficacious or cost effective than
any therapy or treatment that we and our collaborators hope to
develop, issues involving product liability, issues involving
patents and whether they or licenses to them will provide us 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 we can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
our 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, 2017, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2018
and other regulatory filings we make from time to time. There can
be no assurance that any product candidate in our pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials 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. Forward-looking statements speak only as of the date of
this release, and we undertake no obligation to update or revise
these statements, except as may be required by law.
CONTACTS:
Investors: Ben Matone, Inovio, 484-362-0076,
ben.matone@inovio.comMedia:
Jeff Richardson, Inovio, 267-440-4211,
jrichardson@inovio.com
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