PLYMOUTH MEETING, Pa.,
Nov. 3, 2021 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
bringing to market precisely designed DNA medicines to help protect
people from infectious diseases, and help treat cancer, and
HPV-associated diseases, today announced that it has received
authorization from India's Central
Drugs Standard Control Organization (CDSCO)'s Drug Controller
General of India (DCGI) to proceed
with the Phase 3 segment of INOVIO's global Phase 2/3 trial,
INNOVATE (INOVIO INO-4800 Vaccine
Trial for Efficacy), in India for INO-4800, its DNA vaccine candidate
for COVID-19. INOVIO is partnering with Advaccine
Biopharmaceuticals Suzhou Co., Ltd. (Advaccine) to conduct the
INNOVATE Phase 3 segment in multiple countries in Latin America, Asia, and Africa. Regulatory authorization in
India follows authorizations from
health authorities in Brazil,
Philippines, Mexico and Colombia.
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.
"As COVID-19 continues to threaten the health and safety of the
global population, and many areas of the world are still awaiting
sufficient access to safe and effective vaccines, INOVIO is pleased
to receive regulatory authorization to proceed with our efficacy
Phase 3 trial in India," said Dr.
J. Joseph Kim, President and CEO of
INOVIO. "INOVIO remains steadfast in its mission to fight COVID-19
through the development of INO-4800, which is designed to serve the
needs of those in India and
beyond, as both a primary series and 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. Interim Phase 2 data from the ongoing study
was disclosed in a pre-print in MedRxiv in May 2021 and showed 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 notable 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.
This news builds on INOVIO's previously
announced authorization to proceed in China with two Advaccine-sponsored clinical
trials investigating the safety, tolerability, and immunogenicity
of heterologous boost combinations with INO-4800, as well as recent
positive homologous boosting data for INO-4800, which was
found to produce robust immune responses and was well-tolerated as
both a two-dose series and as a homologous booster dose in all
adults, including participants 65 years of age and older. Of note,
a durable antibody response was observed six months following the
second dose, and a homologous booster dose administered 6 to 10.5
months following the second dose also significantly increased
antibody and T cell responses. INO-4800 was well-tolerated, with no
treatment-related serious adverse events reported. Most adverse
events were mild in severity and did not increase in frequency with
age and subsequent dosing.
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, Philippines, and India. 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 September 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.