INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S.
PR92917
PLYMOUTH MEETING, Pa., Nov. 9, 2021 /PRNewswire=KYODO JBN/ --
- FDA Lifts Partial Clinical Hold on INNOVATE Phase 3 Segment
INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market
precisely designed DNA medicines to help protect people from infectious
diseases and treat cancer and HPV-associated diseases, today announced that the
U.S. Food and Drug Administration (FDA) provided authorization to proceed for
INOVIO's INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800,
in the U.S. The FDA has lifted the partial clinical hold following the FDA's
review of additional non-clinical, clinical, and device information provided by
INOVIO.
Dr. J. Joseph Kim, INOVIO's President and CEO, said, "I want to recognize and
express my appreciation to my INOVIO colleagues for their hard work throughout
this process. We are pleased to have the opportunity for U.S. clinical trial
participants to potentially contribute to the enrollment in our INNOVATE Phase
3 segment. Today's U.S. announcement builds on our intensive global efforts in
India, Brazil, Philippines, Mexico, Colombia, and Thailand where we have
received authorizations to date."
INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to
conduct the INNOVATE Phase 3 segment in multiple countries in the Americas,
Asia, and Africa. 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 symptomatic COVID-19.
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 degrees C for
more than a month, has a five-year projected shelf life at normal refrigeration
temperatures 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 vaccine candidate 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 vaccine candidate against COVID-19, in a Phase 2/3 clinical trial;
the Phase 3 segment of which has received regulatory authorizations to proceed
in Colombia, Mexico, Brazil, Philippines, India, Thailand, and the United
States. 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, our ability
to successfully manufacture and produce large quantities of our product
candidates if they receive regulatory approval and planned collaborations with
third parties. 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.
SOURCE INOVIO Pharmaceuticals, Inc.
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