PLYMOUTH MEETING, Pa.,
July 25, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) today announced that positive
results from the first-in-human trial of its vaccine against the
Middle East Respiratory Syndrome Coronavirus (MERS) were published
in The Lancet Infectious Diseases. This peer-reviewed
article entitled, "Safety and immunogenicity of an
anti-Middle East respiratory
syndrome coronavirus DNA vaccine: A phase 1, open-label,
single-arm, dose-escalation trial," highlights clinical results of
Inovio's collaborative vaccine study of INO-4700 (also called
GLS-5300) against MERS delivered with the CELLECTRA®
efficacy-enhancing device.
Dr. J. Joseph Kim, Inovio
President and CEO, said, "This latest publication underscores the
potential for rapid deployment of Inovio's DNA vaccines.
Impressively, INO-4700 was advanced into the clinic within nine
months of vaccine candidate selection -- the first MERS vaccine in
humans. Inovio is planning a Phase 2 MERS vaccine trial to be
conducted in areas of the world where outbreaks have occurred,
funded through our previously established collaboration with CEPI
dependent on Phase 1b/2a data."
Inovio and GeneOne Life Science, Inc. (KSE: 011000) are
co-developing INO-4700 in this 75-participant clinical trial
conducted at the Walter Reed Army Institute of Research Clinical
Trials Center (WRAIR) in Silver
Spring, MD. Subjects vaccinated with INO-4700
displayed robust levels of MERS antigen-specific antibody and T
cell responses at week 14 (two weeks post-third dose). These
vaccine-generated immune responses to INO-4700 were durable as they
were maintained through 60 weeks following dosing. Inovio's MERS
DNA vaccine was well-tolerated and demonstrated overall high levels
of antibody responses in 94% of subjects, while also generating
broad-based T cell responses in 88% of study participants.
Furthermore, INO-4700 administration generated antibody responses
with similar potency compared to those of patients who were
infected with MERS virus and subsequently recovered from the South
Korea MERS outbreak. Even more interestingly, the vaccination
generated more robust T cell responses than convalescent patients,
suggesting the vaccine's ability to protect from reinfection from
MERS virus.
MERS is a severe respiratory disease akin to the Severe Acute
Respiratory Syndrome (SARS) and was first identified in
Saudi Arabia in 2012. MERS has
infected more than 2,400 people and killed nearly 35% of those
infected. There are currently no licensed vaccines or specific
treatments for MERS. MERS has been identified as a priority disease
by the World Health Organization (WHO) and as a top target for
vaccine development by the Coalition for Epidemic Preparedness
Innovations (CEPI).
Dr. Kayvon Modjarrad, director of
WRAIR's Emerging Infectious Diseases Branch, the principal
investigator of the study and first author on the publication,
said, "The world witnessed the emergence and devastation of SARS in
2002 and then MERS 10 years later. MERS hasn't gone away. And
there's every indication that the family of viruses to which SARS
and MERS belong, coronaviruses, are here to stay. U.S. military
personnel are at particular risk for MERS, given the deployments to
the Middle East and South Korea where the largest MERS outbreaks
have occurred. This study is, therefore, an important advancement
for the U.S. Army, the military community as a whole and the global
stakeholders in the research and development of both MERS and
corona virus countermeasures."
This study was funded by the U.S. Department of the Army and
GeneOne Life Science, Inc. and conducted at WRAIR. This work was
partially supported through a cooperative agreement
(W81XWH-07-2-0067) between the Henry M. Jackson Foundation for the
Advancement of Military Medicine, Inc., and the U.S. Department of
Defense (DoD). GeneOne and the International Vaccine Institute have
continued the clinical development efforts on this vaccine as part
of a second, Phase 1b/2a trial that
is currently ongoing in Korea with the interim data expected later
this year. The Wistar Institute also collaborated on the
development of this vaccine.
Inovio plans to initiate a larger Phase 2 field trial in the
Middle East with through a
partnership with CEPI, based on Phase 1b/2a data for INO-4700. Inovio received a
$56 million funding last year from
CEPI 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.
About MERS
Middle East Respiratory Syndrome (MERS) is caused by a
coronavirus that is related to the virus which causes severe acute
respiratory syndrome (SARS). While the SARS coronavirus
infected and caused illness in more than 8,000 people worldwide,
the disease was short-lived between 2002 and 2004 and had a case
fatality rate of about 10%. Since the MERS was first identified in
Saudi Arabia in 2012, as of
May 2018 the World Health
Organization indicates that laboratory-confirmed MERS cases have
been reported for 2,449 people worldwide, with 849 deaths, for a
case fatality rate of 35%. Local occasional transmission is
still ongoing, primarily in Saudi
Arabia where hospital outbreaks occurred earlier this year.
Highlighting the global concern for MERS, in the summer of 2015 a
single business person returned to South
Korea from Saudi Arabia and
was the index case for a South
Korea epidemic in 17 hospitals around the country.
That epidemic was comprised of 186 confirmed cases with a 20% case
fatality rate.
About Inovio Pharmaceuticals, Inc.
Inovio is an innovative clinical stage biotechnology company
focused on the discovery, development, and commercialization of its
synthetic DNA technology targeted against cancers and infectious
diseases. Inovio's proprietary technology platform applies antigen
sequencing and delivery to enable in vivo protein expression, which
can activate potent immune responses to targeted diseases. The
technology 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 development for the treatment of
HPV-related cervical pre-cancer. Also in development are Phase 2
immuno-oncology programs targeting HPV-related cancers and
glioblastoma, as well as externally funded platform development
programs in Zika, MERS, Lassa and HIV. Partners and collaborators
include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio
Corporation, GeneOne Life Science, The Bill & Melinda Gates
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI),
Defense Advanced Research Projects Agency, National Institutes of
Health, National Institute of Allergy and Infectious Diseases,
National Cancer Institute, HIV Vaccines Trial Network, Walter Reed
Army Institute of Research, Medical CBRN Defense Consortium (MCDC),
The Wistar Institute, and the University of
Pennsylvania. For more information, visit
www.inovio.com.
About GeneOne Life Science, Inc.
GeneOne Life Science, Inc. ("GeneOne" KOSPI: 011000),
headquartered in Seoul, South
Korea, is an international biotechnology company. GeneOne is
developing DNA vaccines, DNA-based therapeutics, and small
molecules for conditions with unmet medical needs such as virulent
infectious diseases, cancer, metabolic and inflammatory diseases in
South Korea and globally. VGXI,
Inc., located in Texas, is a
wholly-owned subsidiary of GeneOne. VGXI is the leading contract
manufacturer globally of high-quality, clinical-grade DNA plasmids
for use in vaccines, therapeutics, and gene-therapy used by
companies and institutions worldwide and is the manufacturer of the
GLS-5300/INO-4700 MERS-CoV DNA plasmid vaccine. For more
information, visit http://www.genels.com/en.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA-based immunotherapies, 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 immunotherapies, 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, our Quarterly Report on Form
10-Q for the quarter ended March 31,
2019 and other filings we make from time to time with the
Securities and Exchange Commission. 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 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.