PLYMOUTH MEETING, Pa.,
March 21, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) announced today that its Ebola
vaccine, INO-4201, was safe, tolerable, and generated strong T cell
and antibody responses. This Phase 1 data was published in The
Journal of Infectious Diseases and further supports the
advancement of the intradermal delivery platform for emerging
infectious diseases. Significantly, the study demonstrated
that intradermal (skin) administration with Inovio's
CELLECTRA® delivery device resulted in 100% of evaluable
subjects generating antigen-specific antibody responses that
persisted for more than one year in most subjects and generated T
cell responses equivalent to or better than the group that received
intramuscular delivery. The published data further validates the
safety, potency, and product stability advantages of Inovio's
vaccine and immunotherapy platform.
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Dr. J. Joseph Kim, Inovio's
President and CEO, said, "INO-4201 has already demonstrated
protection in 100% of non-human primates following a challenge with
a lethal dose of the Ebola virus. With strong preclinical and human
data, Inovio is executing on our overall development strategy in
advancing INO-4201 as a viable stockpile vaccine. Because Inovio's
Ebola vaccine can be used to protect against Ebola infection and
can be boosted multiple times without any anti-vector response, it
could be employed to boost viral vector vaccines that cannot be
effectively re-administered. We now look to secure partner funding
to further advance our Ebola vaccine as a stand-alone vaccine as
well as a boost for those previously immunized with viral vector
vaccines."
Unlike viral vector vaccines which must be kept frozen, INO-4201
is stable at room temperature for more than one year. Non-live
vaccine approaches that are simple to deliver and stable at room
temperature are desirable in controlling Ebola virus outbreaks.
Inovio's Ebola vaccine was evaluated in five groups of healthy
subjects. Of 70 evaluated subjects, 67 (96%) seroconverted and
mounted a strong antibody response to the Ebola glycoprotein
antigen following the three dose immunization regimen; 52 subjects
(76%) seroconverted after only two doses.
Significantly, in the study arm using intradermal (skin)
administration, 13 of 13 evaluable subjects (100%) generated
antigen-specific antibody responses after only two doses and all
remained seropositive after three immunizations.
To date INO-4201 has been well-tolerated and has not
demonstrated systemic serious adverse effects, such as fever, joint
pain, and low white blood cell counts, reported in association with
some viral vector-based Ebola vaccines currently in
development.
More information on this study, fully funded by U.S. Defense
Advanced Research Projects Agency (DARPA), can be found in the most
recent edition of The Journal of Infectious Diseases in the
article entitled, "Intradermal SynCon® Ebola GP DNA
Vaccine is Temperature Stable and Safely Demonstrates Cellular and
Humoral Immunogenicity Advantages in Healthy Volunteers," authored
by Inovio and its collaborators.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA-based
immunotherapies and vaccines that transform the treatment and
prevention of cancer and infectious disease. Inovio's
proprietary technology platform applies 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'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
HPV-related cancers, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include AstraZeneca,
Regeneron, Roche/Genentech, ApolloBio Corporation, The Wistar
Institute, The Bill & Melinda Gates Foundation, the
University of Pennsylvania, Parker
Institute for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life
Science, Plumbline Life Sciences, NIH, HIV Vaccines Trial Network,
National Cancer Institute, Walter Reed Army Institute of Research,
Drexel University, 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. 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, 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:
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Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.