PLYMOUTH MEETING, Pa.,
Aug. 26, 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 regulatory
authorization from Brazil's ANVISA
(Agência Nacional de Vigilância Sanitária), the national health
regulatory agency of Brazil, to
initiate the global Phase 3 segment of its Phase 2/3 trial,
INNOVATE (INOVIO INO-4800 Vaccine Trial
for Efficacy), for INO-4800, its DNA vaccine candidate for
COVID-19. INOVIO plans to conduct the global INNOVATE Phase 3
segment in multiple countries, including Brazil, with partner Advaccine
Biopharmaceuticals Suzhou Co., Ltd. (Advaccine).
The global Phase 3 segment of the INNOVATE Phase 2/3 clinical
trial will evaluate the efficacy of INO-4800 in a two-dose regimen
(2.0 mg per dose), administered one month apart, in a two-to-one
randomization in men and non-pregnant women 18 years of age and
older in several countries across Latin
America, Asia, and
Africa. 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, "With many countries in the world experiencing
low vaccination rates and seeing an increase in infections, we feel
the urgency to advance INO-4800 globally. I am incredibly proud of
the INOVIO team and grateful to the health authorities in
Brazil for their commitment to
advancing the fight against COVID-19. INOVIO's focus on supporting
the global response to the pandemic is unwavering – and will bring
forward the potential advantages of INO-4800, which in addition to
being well-tolerated with balanced neutralizing antibodies and T
cell responses (CD8 and CD4), has a strong thermostability profile,
and potentially offers the ability to serve as both a primary as
well as a booster vaccine."
INOVIO's DNA medicines have shown the following overall
characteristics:
- Well-tolerated and Easy to Administer: INO-4800 has a
strong safety profile and, unlike other COVID-19 vaccine
candidates, INO-4800 is administered intradermally and has caused
only very limited side effects (mostly mild injection site
reactions).
- Immunogenic: INO-4800 demonstrated robust immune
responses: 100% of Phase 1 participants demonstrated overall
immunological response rates and had balanced neutralizing
antibodies and favorable T-cell responses (CD8 and CD4).
- Stable and Transportable: INO-4800 has a favorable
thermostability profile. The vaccine candidate is projected to be
stable at room temperature for more than a year, at 37°C for more
than a month, has a 3 to 5-year projected shelf life at 2-8°C and
does not need to be frozen during transport or storage – a critical
element when considering the feasibility of global
distribution.
- Characterizable and Scalable: INO-4800 is highly
characterizable, scalable to population levels, and safe. The
highly characterizable nature of the vaccine enables timely scaling
of manufacturing with multiple manufacturing facilities able to be
utilized.
- Repeat Administration: INO-4800 can be safely
readministered offering the potential for seasonal boosting usage
without any concerns of generating an anti-vector response or
formulation related issues.
The global Phase 3 segment of the Phase 2/3 INNOVATE trial
builds upon the Phase 2 segment conducted in the U.S., which was
funded by the U.S. Department of Defense Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense,
(JPEO-CBRND) in coordination with the Office of the Assistant
Secretary of Defense for Health Affairs (OASD(HA)) and the Defense
Health Agency. Results from the trial can be found in the paper
entitled "Safety and immunogenicity of INO-4800 DNA vaccine against
SARS-CoV-2: A Preliminary Report of a Randomized, Blinded,
Placebo-controlled, Phase 2 Clinical Trial in Adults at High Risk
of Viral Exposure," which has been disclosed in a pre-print in
MedRxiv prior to peer review. Early INO-4800 research and
development funding were provided by the Coalition for Epidemic
Preparedness Innovations (CEPI) and the Bill & Melinda Gates
Foundation. The Phase 2 data showed INO-4800 was 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 the SARS-CoV-2 virus as it
shifts from pandemic to endemic spread.
Earlier this month, INOVIO announced the authorization to
proceed in China with two clinical
trials investigating heterologous boosting with INO-4800 through
Advaccine as the trial sponsor. Working with Sinovac Biotechnology
(Sinovac), Advaccine will evaluate the safety, tolerability, and
immunogenicity of heterologous prime-boost sequential immunizations
using INO-4800 and CoronaVac®, an inactivated COVID-19
vaccine developed by Sinovac and authorized for emergency use by
the World Health Organization.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2,
the coronavirus that causes COVID-19. Composed of a precisely
designed DNA plasmid, INO-4800 is injected intradermally followed
by electroporation using a proprietary smart device delivering the
DNA plasmid directly into cells in the body and is intended to
produce a well-tolerated immune response. INO-4800 is the only
nucleic-acid based vaccine 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 – all which
INOVIO believes are important considerations for mass
immunizations.
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.
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SOURCE INOVIO Pharmaceuticals, Inc.