Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that its
Ebola vaccine, INO-4212, was safe, tolerable, and generated strong
T cell and antibody responses in its fully enrolled phase I study
of 75 healthy subjects. Detailed immunogenicity and safety data is
being prepared for peer-reviewed publication. In previously
reported preclinical testing in mice and non-human primates, the
Ebola vaccine protected 100% of immunized animals from sickness and
death following exposure to a lethal dose of Ebola virus.
This human study (CT.gov: NCT02464670) was
conducted by an Inovio-led consortium, which was selected and
awarded $45 million by the U.S. Defense Advanced Research Projects
Agency (DARPA) in 2015 to take a multi-faceted approach to prevent
and treat Ebola infection.
This initial trial evaluated INO-4212 in five
groups of healthy subjects. INO-4212 consists of two optimized
SynCon® DNA plasmids coding for the Ebola glycoprotein antigen from
circulating Ebola strains from 1975 - 2014. These plasmids were
tested separately and together in muscle and skin in five study
arms, one including Inovio’s DNA-based IL-12 immune activator. Of
69 evaluated subjects, 64 (92.7%) seroconverted and mounted a
strong antibody response to the Ebola glycoprotein antigen
following the three dose immunization regimen; 48 subjects (69.6%)
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.
Similarly, in the study arm receiving the vaccine with
intramuscular administration in combination with plasmid IL-12, 12
of 13 evaluable subjects (92.3%) demonstrated strong antibody
responses after only two immunizations and 13 of 13 (100%) produced
strong antibody responses after three immunizations.
The Ebola glycoprotein specific geometric mean
antibody titers measured in the five cohorts ranged from over 2,000
to greater than 46,000. Significantly, a majority of vaccinated
subjects in each of the five cohorts produced strong Ebola antigen
specific T-cell responses as measured by interferon gamma ELISpot
analysis.
To date INO-4212 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. Moreover, unlike the viral vectored vaccines which
must be kept frozen, INO-4212 was formulated in a solution which
was kept refrigerated (2-8 C).
The data was presented today by Dr. Niranjan Y.
Sardesai, Inovio’s Chief Operating Officer and Principal
Investigator on the DARPA Ebola program, at The World Vaccine
Congress in Washington, DC. Dr. Sardesai said, “The induction of
strong Ebola specific antibody and T cell responses has been
difficult to achieve in previous human studies. We are pleased by
the immune responses achieved using two and three vaccination
regimens in humans with our optimized DNA vaccines delivered using
electroporation, adding to the successful animal immune response
and challenge studies using our approach. We are particularly
excited about the positive immunology data using intradermal
immunization as this delivery would facilitate even greater
clinical and commercial potential for DNA vaccination.”
“These initial data from our Ebola DNA vaccine
represent just a first step in this DARPA-funded program. We look
forward to rapidly moving this DNA vaccine into larger human
studies on the path to product licensure. We are also advancing our
Ebola dMAb™ product and expect to clinically test that
independently of the DNA vaccine approach,” said Dr. J. Joseph Kim,
President and CEO.
Under the DARPA-funded program Inovio and its
collaborators are developing multiple approaches against Ebola.
This program allows for the development and early clinical testing
of:
1) Inovio's DNA-based vaccine against Ebola
2) Inovio's therapeutic Ebola dMAb™ product. This new technology
has properties best suited to respond to an Ebola outbreak in that
the product could be manufactured expediently on a large scale
using proven fermentation technology, is thermal-stable, and may
provide more rapid therapeutic benefit (as shown in Inovio’s
Chikungunya and dengue programs); and
3) A highly potent conventional protein-based therapeutic
monoclonal antibody (mAb) product against Ebola virus infection,
co-developed with MedImmune, the global biologics research &
development arm of AstraZeneca.
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 has reported 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, The Wistar Institute, 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 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, 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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