PLYMOUTH MEETING, Pa.,
April 23, 2021 /PRNewswire/ -- INOVIO
(NASDAQ:INO), a biotechnology company focused on bringing to market
precisely designed DNA medicines to treat and protect people from
infectious diseases, cancer, and HPV-associated diseases, today
announced that it is planning for a predominantly ex-U.S. Phase 3
trial for its COVID-19 vaccine candidate, INO-4800. Given the
increasing availability of vaccines authorized for emergency use,
the Department of Defense Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)
in coordination with the Office of the Assistant Secretary of
Defense for Health Affairs (OASD(HA)) and the Defense Health Agency
(DHA), will discontinue funding for the Phase 3 segment of the
INNOVATE trial, while continuing to fund the completion of the
ongoing Phase 2 segment. In correspondence, JPEO informed INOVIO:
"The decision results from the changing environment of COVID-19
with the rapid deployment of vaccines. This decision is not a
reflection of the awardee or product, rather a fast-moving
environment associated with the former Operation Warp Speed on
decisions related to future products."
This decision does not impact other work that INOVIO does with
the US government and is neither a result of the partial clinical
hold nor a reflection of the data generated to date for INO-4800
vaccine. With existing global collaborators such as INOVIO's
China partner, Advaccine, and the
International Vaccine Institute (IVI,) the company is planning
for a predominantly ex-US global Phase 3 trial based on upcoming
evaluation of Phase 2 safety and immunogenicity data. INOVIO
continues to evaluate its pan-COVID variant vaccine, INO-4802, to
protect against current and future variants of concern, as well as
assessing boosting capabilities for INO-4800. INOVIO remains
well-positioned to support both pandemic and endemic vaccine needs
with INO-4800 and INO-4802. INOVIO and its partners and
collaborators look forward to being part of the global solution to
prevent the spread of COVID-19 – including both current and future
variants.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2,
the coronavirus that causes COVID-19. INOVIO has extensive
experience working with coronaviruses and was the first company to
initiate a Phase 2a trial for INO-4700, a DNA vaccine candidate for
a related coronavirus that causes Middle East Respiratory Syndrome
(MERS).
Composed of an optimized DNA plasmid, INO-4800 is delivered
directly into cells in the body via a proprietary smart device to
produce a robust and tolerable immune response. INO-4800 is the
only nucleic-acid based vaccine that is stable at room temperature
for more than a year, at 37°C for more than a month, has a
five-year projected shelf life at normal refrigeration temperature
and does not need to be frozen during transport or storage – all of
which are important considerations when preparing for mass
immunizations.
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) and the U.S.
Department of Defense. 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®. The
CELLECTRA® device uses a brief electrical pulse to
reversibly open small pores in the cell to allow the plasmids to
enter, overcoming a key limitation of other DNA and other nucleic
acid approaches, such as mRNA. Once inside the cell, the DNA
plasmids enable the cell to produce the targeted antigen. The
antigen is processed naturally in the cell and triggers the desired
T cell and antibody mediated immune responses. Administration with
the CELLECTRA® device ensures that the DNA medicine is
efficiently delivered directly into the body's cells, where it can
go to work to drive 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 designed 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 observed in clinical trials.
With more than 3,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential 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 and protect people
from infectious diseases, cancer, and diseases associated with HPV.
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 is the first DNA medicine to achieve efficacy
endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment
of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18.
VGX-3100 also demonstrated positive Phase 2 efficacy results in
separate trials evaluating the treatment of precancerous vulvar
dysplasia and anal dysplasia. 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)/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Kaneka Eurogentec,
Medical CBRN Defense Consortium (MCDC), National Cancer Institute,
National Institutes of Health, National Institute of Allergy and
Infectious Diseases, Ology Bioservices, the Parker Institute for
Cancer Immunotherapy, Plumbline Life Sciences, Regeneron,
Richter-Helm BioLogics, Thermo Fisher Scientific, 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
and commercialize DNA medicines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of preclinical studies and clinical trials and the
availability and timing of data from those studies and trials, and
our ability to successfully manufacture and produce large
quantities of our product candidates if they receive regulatory
approval. 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, our ability to secure sufficient manufacturing capacity
to mass produce our product candidates, 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 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, 2020 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.