Inovio Ebola Vaccine Demonstrates Robust Immune Responses with Favorable Safety Profile in Expanded Clinical Trial
April 11 2017 - 9:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today
preliminary results from the expanded stage of its phase I study,
EBOV-001. The expanded study examined different regimens of its
Ebola DNA vaccine INO-4201 using intradermal (skin) administration.
The results across both stages of the trial, including both
intramuscular and intradermal delivery, 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.
Previously, Inovio reported positive safety and
immune response data in the first set of 75 healthy volunteers
administered with INO-4212 (60 delivered intramuscularly and 15
intradermally). Based on that result Inovio enrolled an additional
125 subjects in a second stage of this trial to further
characterize and optimize immunization regimens using intradermal
delivery, which is well-suited for this preventive Ebola DNA
vaccine. Across the two stages, 88% (50/57) of evaluable
intramuscular subjects generated an Ebola-specific antibody immune
response; 97% (119/122) of evaluable intradermal subjects generated
an Ebola-specific antibody immune response.
In an accompanying preclinical study, INO-4201
protected 100% of rhesus monkeys challenged with a lethal dose of
the Ebola virus following vaccination with two intradermal doses of
INO-4201.
Dr. Scott White, Inovio’s Vice President of
Clinical Development, is presenting this data today at the World
Vaccine Congress in Washington, D.C.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “This response rate mirrors the high response rates we
recently reported from our MERS and Zika clinical studies,
reinforcing Inovio’s ability to rapidly design and construct
vaccines against emerging global infectious diseases. With these
strong results from 200 subjects and positive preliminary
preclinical data from several animal species, we plan to meet with
regulators this year regarding a path forward for the licensure of
our Ebola product.”
Inovio’s Ebola vaccine program is funded by a
$45 million contract received from DARPA to develop an Ebola
vaccine and DNA-based monoclonal antibody therapy. A more detailed
data set and analysis from this study is being prepared for
publishing in a peer-reviewed journal.
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 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, ApolloBio
Corporation, 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 the Ebola immunotherapy INO-4212,
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, 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, 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, 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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