INOVIO Receives Regulatory Authorization to Conduct Phase 3 Efficacy Trial of its COVID-19 DNA Vaccine Candidate, INO-4800, in Mexico
PR91834
PLYMOUTH MEETING, Pa., Sept. 22, 2021 /PRNewswire=KYODO JBN/ --
-- News follows recent regulatory authorizations to proceed with the trial
in Brazil and the Philippines
-- INOVIO and partner Advaccine are collaborating on the global Phase 3
trial in regions underserved by COVID-19 vaccines; to focus on Latin
America, Asia, and Africa
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(R), 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.
Source - INOVIO Pharmaceuticals, Inc.
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