PLYMOUTH MEETING, Pa.,
Oct. 11, 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 Colombia's INVIMA (Instituto Nacional de
Vigilancia de Medicamentos y Alimentos, or the National Food and
Drug Surveillance Institute), to conduct the Phase 3 segment of
INOVIO's global Phase 2/3 trial, INNOVATE (INOVIO
INO-4800 Vaccine Trial for Efficacy) in
Colombia, for INO-4800, its DNA
vaccine candidate for COVID-19. INOVIO is working with partner
Advaccine Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) on the
INNOVATE Phase 3 segment in multiple countries, with a focus on
countries in Latin America,
Asia, and Africa. INOVIO recently announced that it
has received regulatory authorization to proceed in Brazil, Philippines, and Mexico.
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 is pleased to share the news of the
regulatory authorization to proceed with our Phase 3 trial in
Colombia. With COVID-19 rates
continuing to rise in many areas, and with continued limitations to
vaccine access in many countries globally, we are grateful to the
multiple health authorities who are supporting our efforts to
advance the efficacy evaluation of our COVID-19 vaccine. INO-4800
is well-positioned to support vaccination efforts in Colombia and beyond, if approved – with the
prospects of potentially serving both as a primary series and as a
booster vaccine, with a strong thermostability profile and ability
to generate neutralizing antibodies and robust T cell
responses."
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 the trial. 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 recently announced 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.
About INO-4800
INO-4800, INOVIO's DNA vaccine candidate against SARS-CoV-2, 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 as a primary
series as well as a booster.
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 Phase 2/3 clinical trial; the
Phase 3 efficacy segment of which has received regulatory approvals
to begin in Mexico, Brazil and Philippines. INOVIO's partners, Advaccine
Biopharmaceuticals, and International Vaccine Institute, are also
evaluating INO-4800 in ongoing clinical trials in China and South
Korea, respectively.
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
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.