PLYMOUTH MEETING, Pa.,
Sept. 22, 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 has received authorization from COFEPRIS
(Comisión Federal para la Protección contra Riesgos Sanitarios),
the national health regulatory agency of Mexico, to conduct a clinical trial in that
country as part of the Phase 3 segment of INOVIO's global Phase 2/3
trial, INNOVATE (INOVIO INO-4800 Vaccine
Trial for Efficacy), for its DNA vaccine candidate
for COVID-19, INO-4800. INOVIO is working with its partner
Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the
INNOVATE Phase 3 segment in multiple countries. INOVIO recently
announced that it has received regulatory authorization to
proceed with Phase 3 clinical trials in Brazil and the Philippines and is seeking authorization to
conduct trials in additional countries.
The global Phase 3 segment of INNOVATE will evaluate the
efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose),
administered one month apart, in a 2-to-1 randomization in men and
non-pregnant women 18 years of age and older. The primary endpoint
of this case-driven Phase 3 trial is virologically confirmed
COVID-19.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "INOVIO looks forward to working with the
health authorities and investigators in Mexico – as well as in Brazil and the
Philippines – to advance the evaluation of INO-4800 as a
solution in the fight against the COVID-19 pandemic. With the virus
threatening to become an endemic threat worldwide, while millions
of people around the globe remain unvaccinated, we are committed to
supporting the international public health response. I am extremely
pleased that we are now positioned to evaluate the efficacy of
INO-4800 which is an important developmental milestone. We feel
that INOVIO's COVID-19 vaccine is uniquely suited to contribute to
the global response given its strong safety and thermostability
profile, ability to generate cross-reactive immune responses, and
its potential to function in a primary series as well as a booster
vaccine."
INNOVATE's Phase 3 segment builds upon the Phase 2 segment,
which was conducted in the U.S. and funded by the U.S. Department
of Defense Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense, in coordination with the Office
of the Assistant Secretary of Defense for Health Affairs and the
Defense Health Agency. Phase 2 data was disclosed in a
pre-print in MedRxiv in May
2021 and found INO-4800 to be well-tolerated and immunogenic
in adults 18 and older. In another previously disclosed study using
clinical samples, INO-4800 was also found to provide broad
cross-reactive immune responses, including neutralizing antibodies
and robust T cell responses, against variants of concern (alpha,
beta, gamma and, in subsequent research, delta) – factors which
could be critical in containing COVID-19 as it shifts from pandemic
to endemic spread.
INOVIO also announced in August the authorization to
proceed in China with two
Advaccine-sponsored clinical trials investigating the safety,
tolerability, and immunogenicity of heterologous boost combinations
with INO-4800 and Sinovac Biotechnology's CoronaVac®, an
inactivated COVID-19 vaccine developed by Sinovac and authorized
for emergency use by the World Health Organization.
About INO-4800
INOVIO's DNA vaccine candidate against SARS-CoV-2, INO-4800, is
composed of a precisely designed DNA plasmid that is injected
intradermally followed by electroporation using a proprietary smart
device, which delivers the DNA plasmid directly into cells in the
body and is intended to produce a well-tolerated immune response.
As one of the only nucleic-acid based vaccines 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, INO-4800 is anticipated to be well-positioned for first-in
line usage as well as for boosting.
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 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 met
primary and secondary endpoints for all evaluable subjects in
REVEAL 1, the first of two, Phase 3 trials for precancerous
cervical dysplasia, demonstrating ability to destroy and clear both
high-grade cervical lesions and the underlying high-risk HPV-16/18.
INOVIO is also evaluating INO-4800, a DNA vaccine candidate against
COVID-19, in a global Phase 3 clinical trial, as well as Phase 2
trials in China and South Korea.
Partners and collaborators include Advaccine, ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations, Defense Advanced
Research Projects Agency/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense/Department
of Defense, HIV Vaccines Trial Network, International Vaccine
Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium,
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.
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 pre-clinical 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, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2021 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.