PLYMOUTH MEETING, Pa.,
Nov. 16, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
bringing to market precisely designed DNA medicines to treat and
protect people from infectious diseases and cancer, today announced
that it has received clearance from the U.S. Food & Drug
Administration (FDA) to proceed with the Phase 2 segment of its
planned Phase 2/3 clinical trial for INO-4800, its COVID-19 vaccine
candidate. The planned Phase 2/3 clinical trial, called INNOVATE
(INOVIO INO-4800 Vaccine Trial for
Efficacy), is a randomized, blinded, placebo-controlled
safety and efficacy trial of INO-4800 to be conducted in adults in
the U.S. The INNOVATE trial will be funded by the U.S. Department
of Defense (DoD) 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
(DHA).
The Phase 2 segment of the trial is designed to evaluate safety,
tolerability and immunogenicity of INO-4800 in a 2-dose regimen
(1.0 mg or 2.0 mg), in a three-to-one randomization to receive
either INO-4800 or placebo for each dose to confirm the more
appropriate dose(s) for each of three age groups with high risks of
infection (18-50 years, 51-64 years and 65 years and older) for the
subsequent Phase 3 efficacy evaluation. The Phase 3 segment of the
INNOVATE trial remains on partial clinical hold until INOVIO
satisfactorily resolves the FDA's remaining questions related to
the CELLECTRA® 2000 device that will be used to
deliver INO-4800 directly into the skin. The company plans to
resolve the remaining device questions during the conduct of Phase
2 segment and prior to the start of the Phase 3 segment of the
trial.
"I am extremely proud of the INOVIO team, which has been working
tirelessly to develop a safe and effective vaccine in the fight
against the COVID-19 pandemic. Initiation of our Phase 2 trial
marks a pivotal milestone for INO-4800," said INOVIO's President
and CEO, Dr. J. Joseph Kim. "We are
especially pleased to continue our partnership with the DoD to
advance the development of INO-4800 for active duty service members
and civilian personnel and are grateful for the Department's
continued confidence in our technology to combat COVID-19."
Dr. Kim continued, "INO-4800's key differentiators are the
safety and tolerability data we have observed thus far, as well as
its excellent thermostability profile – making it possible to
manufacture at scale and transport without frozen cold chain
requirements. INO-4800 also maintains the ability to be safely
re-administered and is differentiated by its ability to stimulate
both CD4+ and CD8+ T cell responses."
The FDA's authorization to proceed is based on its review of
INOVIO's non-clinical data, device information and interim Phase 1
safety and immunogenicity data as well as its design and plans for
the Phase 2 and Phase 3 segments of the planned clinical trial. The
Phase 2 segment of the trial is expected to enroll approximately
400 participants at up to 17 U.S. sites to evaluate safety and
immunogenicity in order to confirm the dose(s) for the subsequent
efficacy evaluation planned for the Phase 3 segment.
The DoD has agreed to provide funding for both the Phase 2 and
Phase 3 segments of the INNOVATE clinical trial, in addition to the
$71 million of funding previously
announced in June for the large-scale manufacture of the company's
proprietary smart device CELLECTRA® 3PSP and the
procurement of CELLECTRA® 2000 devices.
About the INO-4800 "INNOVATE" Phase 2/3 Clinical
Trial
The lead Principal Investigator for the INNOVATE trial is Dr.
Pablo Tebas, Professor of Medicine
at the Hospital of the University of
Pennsylvania. The Phase 2 segment of the trial is designed
to evaluate safety, tolerability and immunogenicity of INO-4800 in
a 2-dose regimen (1.0 mg or 2.0 mg), in a three-to-one
randomization to receive either INO-4800 or placebo for each dose,
to confirm the more appropriate dose(s) for each of three age
groups (18-50 years, 51-64 years and 65 years and older) for the
subsequent Phase 3 efficacy evaluation. The company intends to work
diligently to ensure diversity in enrollment, targeting specific
populations that are working or residing in environments with high
infection rates and/or areas where there is greater risk of
exposure to SARS-CoV-2, for whom exposure may be relatively
prolonged or for whom personal protective equipment (PPE) may be
inconsistently used, especially in confined settings.
In the Phase 3 segment of the trial, INOVIO intends to enroll
healthy men and non-pregnant women 18 years and older, to evaluate
the efficacy of the proposed dose(s) based on the data from the
Phase 2 evaluation. Participants will be enrolled in a
one-to-one randomization to receive either INO-4800 or a placebo.
The Phase 3 segment will be case-driven with the final number of
enrollees to be determined by the incidence of COVID-19 during the
Phase 3 segment. The primary endpoint of the Phase 3 segment will
be virologically confirmed COVID-19 disease.
About INOVIO's Global Coalition Advancing INO-4800
INOVIO has assembled a global coalition of collaborators,
partners and funders to rapidly advance the development of
INO-4800. R&D collaborators to date include the Wistar
Institute, the University of
Pennsylvania, the University of
Texas, Fudan University and Laval
University. INOVIO has partnered with Advaccine and the
International Vaccine Institute to conduct clinical trials of
INO-4800 in China and South Korea, respectively. INOVIO is also
assessing nonclinical efficacy of INO-4800 in several animal
challenge models with Public Health England (PHE) and Commonwealth
Scientific and Industrial Research Organization (CSIRO) in
Australia. INOVIO is working with
a team of contract manufacturers including Thermo Fisher
Scientific, Richter-Helm BioLogics, and Ology Bioservices to
manufacture INO-4800 on a commercial scale and is seeking
additional external funding and partnerships to further scale up
manufacturing capacities to satisfy the urgent global demand for
safe and effective vaccines. To date, the Coalition for Epidemic
Preparedness Innovations (CEPI), the Bill & Melinda Gates
Foundation, and the U.S. Department of Defense have contributed
significant funding to the advancement and manufacturing of
INO-4800.
About INO-4800
INO-4800 is INOVIO's DNA vaccine candidate intended to protect
against SARS-CoV-2, the novel coronavirus that causes COVID-19.
INOVIO has extensive experience working with coronaviruses and was
the first company to initiate a Phase 2a trial for INO-4700, a
vaccine for Middle East Respiratory Syndrome (MERS), another
coronavirus related to SARS-CoV-2.
INO-4800 is the only nucleic-acid based vaccine that is stable
at room temperature for more than a year and does not need to be
frozen in transport of storage, which are important factors when
implementing mass immunizations.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. The CELLECTRA device uses
a brief electrical pulse to reversibly open small pores in the cell
to allow the plasmids to enter, overcoming a key limitation of
other DNA and other nucleic acid approaches, such as mRNA. Once
inside the cell, the DNA plasmids enable the cell to produce the
targeted antigen. The antigen is processed naturally in the cell
and triggers the desired T cell and antibody-mediated immune
responses. Administration with the CELLECTRA device ensures that
the DNA medicine is efficiently delivered directly into the body's
cells, where it can go to work to drive an immune response.
INOVIO's DNA medicines do not interfere with or change in any way
an individual's own DNA. The advantages of INOVIO's DNA medicine
platform are how fast DNA medicines can be designed and
manufactured; the stability of the products, which do not require
freezing in storage and transport; and the robust immune response,
safety profile, and tolerability that have been observed in
clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential to meet urgent
global health needs.
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 and only 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, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 91% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. Partners
and collaborators include Advaccine, ApolloBio Corporation,
AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for
Epidemic Preparedness Innovations (CEPI), Defense Advanced Research
Projects Agency (DARPA)/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Medical CBRN
Defense Consortium (MCDC), 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. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. 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 manufacture DNA medicines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of the Phase 2/3 clinical trial of INO-4800, 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 preclinical 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 our 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, 2019, our
Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 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.