Inovio Pharmaceuticals Expands Positive Phase I Ebola Vaccine Trial to Identify Most Optimal Immunization Regimen
August 11 2016 - 08:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the
company is more than doubling study enrollment to further
characterize and identify in humans the most optimal immunization
regimen using intradermal (skin) delivery of its preventive Ebola
DNA vaccine. Inovio is enrolling 125 subjects in a second stage of
its phase I trial of INO-4212 after generating positive initial
safety and immune response data in the first set of 75 healthy
volunteers. The study will assess immune response characteristics
generated with fewer intradermal administrations, lower doses, and
with and without its DNA-based IL-12 immune activator.
The initial 75-subject stage of the trial
evaluated INO-4212 in muscle and skin in five study arms in two and
three doses, one including Inovio’s DNA-based IL-12 immune
activator. In a study arm using intradermal administration, 100%
(13/13) of subjects generated antigen-specific antibody responses
after only two doses. Similarly, in a study arm receiving the
vaccine with intramuscular administration in combination with
plasmid IL-12, 12 of 13 evaluable subjects (92%) demonstrated
strong antibody responses after only two immunizations and 100%
produced strong antibody responses after three immunizations. A
majority of vaccinated subjects in each of the five cohorts
produced strong Ebola antigen-specific T-cell responses.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “Immune responses from our Ebola vaccine in the first group
of vaccine recipients met our highest expectations. Our aim is to
pursue a regulatory approval path for Ebola using the Animal Rule,
which relies on showing safety in humans and efficacy in multiple
animal species. To pursue this path, apart from showing efficacy in
animals we will require data supporting an optimal immunization
regimen able to generate robust antigen specific immune responses
in humans. Our goal now is to characterize the best immunization
regimen and continue building the safety database required for
regulatory approval.
“We plan to meet with regulators regarding a
path forward following the close of this study early next year with
results from 200 patients and positive preliminary pre-clinical
data from several animal models, which we already have in
hand.”
This expanded human study (CT.gov: NCT02464670)
is being 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.
To date INO-4212 has been well tolerated and not
demonstrated systemic serious adverse effects, such as fever,
severe joint pain, and low white blood cell counts, reported in
association with some viral vector based Ebola vaccines currently
in development. Moreover, unlike viral vectored vaccines, which
must be kept frozen, INO-4212 was formulated in a refrigerated
solution (2-8 C).
Under this DARPA-funded program, Inovio and its
collaborators are developing multiple approaches against Ebola.
This program allows for the development and early clinical testing
of:
- Inovio's DNA-based vaccine INO-4212 against Ebola.
- Inovio's therapeutic Ebola dMAb® product. This new technology
has properties complementary to Inovio’s Ebola DNA vaccine to
potentially protect against Ebola. For example, while a DNA vaccine
may provide longer lasting protection, an Ebola dMAb product may
provide more rapid therapeutic benefit (as shown in Inovio’s
Chikungunya and dengue programs); and
- 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, The Wistar Institute, University of Pennsylvania, 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 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 immunotherapy and vaccine
products, our ability to advance our portfolio of immuno-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,
our Form 10-Q for the quarter ended June 30, 2016, 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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