PLYMOUTH MEETING, Pa.,
Oct. 21, 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 the signing of a non-binding memorandum
of understanding (MOU) with Colombia's Ministry of Health and Social
Protection reflecting the intent to advance efforts to combat the
pandemic and endemic threat posed by COVID-19 and to better
prepare for future public health emergencies. The MOU creates a
framework for a collaboration arrangement under which INOVIO and
the government plan to explore knowledge sharing, technology
licensing, and capacity building that support developing and
producing vaccines and other biopharmaceuticals in Colombia. The potential results of these
efforts include developing local manufacturing capabilities for
INOVIO's DNA medicines and related products and technologies.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "INOVIO's memorandum of understanding with
Colombia is a sign of our shared
commitment to develop and advance potentially life-saving DNA
medicines and vaccines to those in need. This partnership grew out
of the intended advantages of INOVIO's DNA medicines platform to
address current and future global health threats due to the
anticipated stability of its product candidates, speed of design
and manufacture, as well as the immune response and tolerability
that have been observed to date in clinical trials."
The framework of the planned collaboration builds on
INOVIO's recently announced authorization to proceed in
Colombia with the Phase 3 segment
of its global Phase 2/3 clinical trial, INNOVATE, for INO-4800, the
company's 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 underserved by COVID-19 vaccines
throughout Latin America,
Asia, and Africa. INOVIO previously
announced approvals to conduct the trial in Brazil, the Philippines, and Mexico.
Dr. Fernando Ruiz Gomez, Minister
of Health and Social Protection, Republic of Colombia, said, "Today is very special for us.
We have a complete circle of what is possible with a North American
company for the production of vaccines, including the possibility
of integrating the work being carried out by the WHO Solidarity
vaccine trial in Colombia that
includes INOVIO as one of the four vaccine candidates in the
clinical studies. As we discussed in the previous meeting today,
the possibility of moving forward quickly is due to INOVIO
considering Colombia as a priority
country, a gesture that we appreciate, and is indicative of the
will of our country and the Ministry of Health to advance the
development of vaccines in Colombia."
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 for a
primary series immunization 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 therapeutic 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 segment of which has received regulatory approvals to
begin in Colombia, 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.