PLYMOUTH MEETING, Pa.,
April 6, 2020 /PRNewswire/
-- INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) today announced
that the U.S. Food and Drug Administration has accepted the
company's Investigational New Drug (IND) application for INO-4800,
its DNA vaccine candidate designed to prevent COVID-19 infection,
paving the way for Phase 1 clinical testing of INO-4800 in healthy
volunteers beginning this week. The first dosing is planned for
today.
Dr. J. Joseph Kim, INOVIO's
President and CEO, said, "This is a significant step forward in the
global fight against COVID-19. Without a new safe and effective
vaccine, the COVID-19 pandemic is likely to continue to threaten
lives and livelihoods. It also demonstrates the power of our DNA
medicines platform to rapidly develop and advance a vaccine for
COVID-19 into Phase 1 clinical testing. Our dedicated team of
staff, partners and funders have been mobilized since the genetic
sequence of the virus became available in early January and
continues to work around the clock to ensure that we are rapidly
advancing INO-4800 through this Phase 1 study towards planned
efficacy trials."
Richard Hatchett, CEO of the
Coalition for Epidemic Preparedness Innovations (CEPI), said, "This
development is an important step forward in the world's search for
a COVID-19 vaccine. INOVIO's DNA vaccine platform was one of the
first technologies selected by CEPI to develop a vaccine candidate
against COVID-19. We are pleased to see the rapid advancement of
their vaccine candidate into clinical safety testing. Producing a
COVID-19 vaccine within the next 12 to 18 months is not only a
scientific challenge; it will also require new levels of
collaboration and investment across industry and government. There
is still a long road ahead before we have a safe, effective, and
globally accessible vaccine ready for broader use, but today we
have reached an important milestone on that journey."
The Phase 1 study of INO-4800 will enroll up to 40 healthy adult
volunteers in Philadelphia, PA (at
the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for
Pharmaceutical Research), where screening of potential participants
has already begun. Study supplies of INO-4800 arrived at the sites
last week. Each participant will receive two doses of INO-4800 four
weeks apart, and the initial immune responses and safety data from
the study are expected by late summer. Preclinical data, which
have been shared with global regulatory authorities and submitted
as part of the IND, have shown promising immune response results
across multiple animal models. Additional preclinical trials,
including challenge studies, will continue in parallel with the
Phase 1 clinical trial.
Dr. Ami Shah Brown, INOVIO's
Senior Vice President of Regulatory Affairs said, "Development and
manufacture of a new vaccine with preclinical data to support a
first-in-human trial in ten weeks from funding is a major milestone
for INOVIO and our collaborators."
To date, preclinical results for INOVIO's COVID vaccine have
been consistent with our completed Phase 1 vaccine study for Middle
East Respiratory Syndrome (MERS), also caused by a coronavirus, in
which INOVIO's DNA vaccine was well tolerated and induced high
levels of antibody responses in 95% of subjects, while also
generating broad-based T cell responses in nearly 90% of study
participants. Durable antibody responses to its DNA vaccine
(INO-4700) used in that trial were maintained through 60 weeks
following dosing.
Upon attaining initial safety and immunogenicity data from Phase
1 studies, INOVIO plans to advance INO-4800 to Phase 2 efficacy
studies as rapidly as possible. In 10 weeks from funding, INOVIO
has manufactured thousands of doses of INO-4800 to support on-going
Phase 1 and planned Phase 2 clinical trials. In parallel, INOVIO is
working to scale up the manufacturing of INO-4800. INOVIO plans to
have one million doses of the vaccine available by year-end for
additional trials and emergency use, pending appropriate regulatory
guidance and funding.
"We anticipate rapid enrollment of this initial study," said
Pablo Tebas, MD, infectious disease
specialist and professor of Medicine at the Hospital of the
University of Pennsylvania and
Principal Investigator of the study. "There has been tremendous
interest in this vaccine among people who want to do what they can
to help protect the greater public from this pandemic as soon as
possible."
"INOVIO's leadership and the team's experience combined with the
consistency of this DNA technology for clinical translation
continue to be a major asset for the program," said Dr.
David B. Weiner, Director of the
Wistar Institute's Vaccine and Immunotherapy Center and Executive
Vice President of the Institute.
INOVIO has assembled a global coalition of collaborators,
partners, and funders to rapidly advance INO-4800. The scientific
team at the Wistar Institute has provided key research
contributions. The INOVIO program has been supported by generous
funding from the Coalition for Epidemic Preparedness Innovations
(CEPI) and the Bill and Melinda Gates Foundation. VGXI, Inc., a
wholly-owned subsidiary of GeneOne Life Science (KSE: 011000) and
INOVIO's manufacturing partner for the last 13 years, enabled the
expedited manufacture, testing, and release of the INO-4800 plasmid
clinical product. The U.S. Department of Defense (DOD) has also
funded INOVIO's collaborator Ology Bioservices to manufacture
additional doses of INO-4800.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI). DNA
medicines are composed of optimized DNA plasmids, which are small
circles of double-stranded DNA that are synthesized or reorganized
by a computer sequencing technology and designed to produce a
specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. CELLECTRA® uses a brief
electrical pulse to open small pores in the cell reversibly to
allow the plasmids to enter, overcoming a key limitation of other
DNA and mRNA approaches. Once inside the cell, the plasmids are
used by the cell's own machinery to generate specific coded
antigens, which then stimulate an immune response. Administration
with the CELLECTRA device ensures that the DNA medicine is
delivered directly into the body's cells, where it can go to work
immediately mounting an immune response. INOVIO's DNA medicines do
not interfere with or change in any way an individual's own DNA.
The advantages of INOVIO's DNA medicine platform are how fast DNA
medicines can be constructed and manufactured, the stability of the
products which do not require freezing in storage and transport,
and the robust immune response, safety profile, and tolerability
that have been demonstrated in clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 6,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates to meet urgent global health
needs.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat, cure, and 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 produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 90% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. Partners
and collaborators include Advaccine, ApolloBio Corporation,
AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for
Epidemic Preparedness Innovations (CEPI), Defense Advanced Research
Projects Agency (DARPA)/DOD, GeneOne Life Science/VGXI, HIV
Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC),
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Ology Bioservices,
Plumbline Life Sciences, Regeneron, Roche/Genentech, University of Pennsylvania, Walter Reed Army
Institute of Research, and The Wistar Institute. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. For
more information, visit www.inovio.com.
CONTACTS:
Media: Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicine candidates, including INO-4800, 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 manufacturing and 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 manufacturing 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 medicines, our ability to
support our pipeline of DNA medicine 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, 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.
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SOURCE INOVIO Pharmaceuticals, Inc.