Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
announced the dosing of the first subject with its vaccine to
prevent infection from the deadly MERS virus (Middle East
Respiratory Syndrome) in a Phase 1/2a study to evaluate INO-4700
(or GLS-5300). The trial is ongoing in South Korea sponsored by
Inovio’s Korean development partner for its MERS vaccine, GeneOne
Life Science (KSE: 011000). The International Vaccine Institute
(IVI) is fully funding this trial utilizing a grant from the
Samsung Foundation committed to IVI to support the development of a
MERS vaccine.
Leveraging results from this study, Inovio
expects to advance its MERS vaccine into a Phase 2 field trial in
the Middle East in 2019 with CEPI funding. Earlier this year,
Inovio received a $56 million grant from CEPI – the Coalition for
Epidemic Preparedness Innovations – under which Inovio will develop
vaccine candidates through Phase 2 against MERS and Lassa fever.
The shared goal of Inovio and CEPI is for a MERS vaccine to be
available as soon as possible for emergency use as a stockpile
post-Phase 2 testing.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “Our goal is to develop a MERS vaccine for emergency
stockpile as soon as possible – moving into a Phase 2 trial next
year in areas of the Middle East where the virus is most present.
Our Korean study is also notable because it will utilize our
intradermal vaccine delivery device which has demonstrated in other
infectious disease trials (HIV, Ebola & Zika) to elicit very
high immune responses at a much lower dose.”
This Phase 1/2a study represents the second
clinical trial for INO-4700, which remains the first and most
advanced MERS vaccine tested in humans. Inovio’s MERS vaccine has
already been demonstrated to be highly immunogenic in a Phase 1
study where it showed that the vaccine was well-tolerated and more
than 90% of treated patients achieved overall high levels of
antibody responses and robust CD8+ T cell responses. Previous
studies have shown that CD8+ T cell responses correlate with
greater survival among MERS infected patients (Zhao 2017, Science
Immunology).
The Korean study will assess vaccine dosing
through an intra-dermal administration that has been shown to be
both better tolerated and equally immunogenic compared to
intra-muscular administration in the previous studies of Inovio’s
Ebola and HIV vaccines. The study will also assess whether a
two-dose vaccine regimen is comparative to a three-dose regimen. In
an earlier preclinical challenge studies, INO-4700 protected 100%
of vaccinated rhesus macaques from a lethal MERS virus challenge
with 2 doses.
Despite the continuing threat of MERS outbreaks,
there are no licensed vaccines or treatments for MERS. Since the
virus was first identified in Saudi Arabia in 2012, the World
Health Organization reports more than 2,000 MERS infections of whom
greater than 36% died. Twenty seven countries have reported cases,
including Korea where an outbreak in the summer of 2015 resulted in
186 cases of whom 20% died. In contrast, the mortality rate as part
of the 2003 SARS epidemic was 10%. MERS causes a rapidly
progressive respiratory illness that may require intensive care
treatment and mechanical ventilation in many patients.
About GeneOne Life Science
GeneOne Life Science Inc. is an international
DNA vaccine developer and leading contract manufacturer of DNA
plasmid-based agents for pre-clinical and clinical trials for
global companies and institutions. It researches and develops DNA
vaccines to prevent and treat incurable diseases in South Korea and
internationally. The company is headquartered in Seoul, South
Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary
located in Texas, is the largest pure-play cGMP DNA plasmid
manufacturing facility in the world. For more information, visit
www.genels.com.
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. The Inovio technology platform is
designed to activate an individual’s immune system to generate a
robust, targeted T cell and antibody response against targeted
diseases. Inovio is the only immunotherapy company that has
reported generating T cells entirely in vivo in high quantity
that are fully functional and whose killing capacity correlates
with relevant clinical outcomes with a favorable safety profile.
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, the Parker Institute for Cancer
Immunotherapy, DARPA, GeneOne Life Science, Plumbline Life
Sciences, Drexel University, National Institute of Allergy and
Infectious Diseases, U.S. Army Medical Research Institute of
Infectious Diseases, NIH, HIV Vaccines Trial Network, U.S. Military
HIV Research Program and CEPI. 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, as well as our plans and expectations
regarding the presentation of data at scientific conferences.
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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