PLYMOUTH MEETING, Pa.,
Jan. 23, 2020 /PRNewswire/ -- Inovio Pharmaceuticals,
Inc. (NASDAQ:INO) today announced the Coalition for Epidemic
Preparedness Innovations (CEPI) has awarded Inovio a grant of up to
$9 million to develop a vaccine
against the recently emerged strain of coronavirus (2019-nCoV) that
has killed numerous people and infected hundreds more in
China to date. This initial CEPI
funding will support Inovio's preclinical and clinical development
through Phase 1 human testing of INO-4800, its new coronavirus
vaccine matched to the outbreak strain. CEPI previously awarded
Inovio a grant of up to $56 million
for the development of vaccines against Lassa fever and Middle East
Respiratory Syndrome (MERS), also caused by a coronavirus.
Inovio's participation in this developing effort is based on the
ideal suitability of its DNA medicine platform to rapidly develop a
vaccine against an emerging virus with pandemic potential, proven
vaccine development capabilities and a strong track record of
rapidly generating promising countermeasures against previous
pandemic threats. Inovio was the first to advance its vaccine
(INO-4700) against MERS-CoV, a related coronavirus, into evaluation
in humans. Inovio is currently preparing to initiate a Phase 2
vaccine trial for INO-4700 in the Middle
East where most MERS viral outbreaks have occurred.
In a recently published paper in Lancet Infectious Diseases,
Inovio's Phase 1 study of its MERS-CoV vaccine demonstrated it was
well tolerated and furthermore induced high levels of antibody
responses in roughly 95% of subjects, while also generating
broad-based T cell responses in nearly 90% of study participants.
Durable antibody responses to INO-4700 were also maintained through
60 weeks following dosing.
Richard Hatchett, CEPI's CEO,
said, "Given the rapid global spread of the 2019-nCoV virus the world needs to act quickly
and in unity to tackle this disease. Our intention with this work
is to leverage our work with Inovio on the MERS coronavirus and
rapid response platform to speed up vaccine development."
Dr. J. Joseph Kim, Inovio's
President & CEO said, "We're extremely honored to expand our
partnership with CEPI to tackle this new threat to global public
health. Our DNA medicine platform represents the best modern day
approach to combatting emerging pandemics. We have already
demonstrated positive clinical outcomes with our vaccine against
MERS-CoV, another coronavirus. Importantly, following the Zika
viral infection outbreak, Inovio and our partners developed a
vaccine that went from bench to human testing in just seven months
– the fastest vaccine development on record in recent decades. We
believe we can further improve upon this accelerated timeline to
meet the current challenge of the emerging Chinese coronavirus
2019-nCoV."
Inovio's collaborators in this coronavirus vaccine development
include the Wistar Institute, VGXI, a fully owned subsidiary of
GeneOne Life Science (KSE: 011000), and Twist Bioscience (NASDAQ:
TWST).
About CEPI
CEPI is an innovative partnership between public, private,
philanthropic, and civil organisations launched in Davos in 2017 to develop vaccines to stop
future epidemics. CEPI has received multi-year funding from
Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates
Foundation, and Wellcome. CEPI has also received single-year
investments from the government of Belgium and the United Kingdom. The European Commission
forsees substantial financial contributions to support relevant
projects through EC mechanisms. CEPI has reached over US$ 750 million of its $1
billion funding target. Since its launch in January 2017, CEPI has announced three calls for
proposals. The first call was for candidate vaccines against Lassa
virus, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and
Nipah virus. The second call was for the development of platforms
that can be used for rapid vaccine development against unknown
pathogens. The third call is for candidate vaccines against Rift
Valley fever and Chikungunya viruses. To date, CEPI has committed
to investing over $310 million in 12
vaccine candidates (five against Lassa virus, four against
MERS-CoV, three against Nipah virus) and two vaccine platforms to
develop vaccines against Disease X.
About Inovio Pharmaceuticals, Inc.
Inovio is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat, cure and/or
protect people from diseases associated with HPV, cancer, and
infectious diseases. Inovio is the first and only company to have
clinically demonstrated that a DNA medicine can be delivered
directly into cells in the body via a proprietary smart device to
safely produce a robust immune response to destroy and clear
high-risk HPV 16 and 18, which are responsible for 70% of cervical
cancer, 90% of anal cancer and 69% of vulvar cancer. In addition to
HPV, Inovio's optimized plasmid design and delivery 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 GBM, as well as
externally funded platform development programs in Zika, MERS,
Lassa, and HIV. Partners and collaborators include ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations (CEPI), Defense
Advanced Research Projects Agency, GeneOne Life Science, HIV
Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC),
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Regeneron,
Roche/Genentech, University of
Pennsylvania, Walter Reed Army Institute of Research, and
The Wistar Institute. For more information, visit
www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicines, our expectations regarding our research and
development programs, as well as commercialization activities,
including the planned initiation and conduct of clinical trials,
the availability and timing of data from those trials and our
commercialization strategy and tactics. 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, product development programs and
commercialization activities and outcomes, 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, 2018, our Quarterly Report on Form
10-Q for the quarter ended September 30,
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:
Investors:
Ben Matone, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.