PLYMOUTH MEETING, Pa.,
Dec. 7, 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
it has dosed its first subject in a Phase 2 clinical trial
evaluating DNA medicine INO-4800, its COVID-19 vaccine candidate,
as part of its Phase 2/3 clinical trial, called INNOVATE
(INovio INO-4800 Vaccine Trial for
Efficacy). The Phase 2 segment of the trial will enroll
approximately 400 participants who are 18 years or older at up to
17 U.S. sites to evaluate safety and immunogenicity in order to
confirm the dose(s) for the subsequent efficacy evaluation as part
of the Phase 3 segment of the trial. INOVIO plans to fully
enroll the Phase 2 segment of the trial by the end of this
month.
INNOVATE is a randomized, blinded, placebo-controlled safety and
efficacy evaluation of INO-4800 being conducted in adults in the
U.S. The INNOVATE trial is 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). For more
information about the clinical trial, see www.clinicaltrials.gov,
identifier NCT04642638.
Dr. J. Joseph Kim, INOVIO's
President & CEO said, "We're pleased to move into the
Phase 2 segment of our 2/3 trial on the pathway to establish our
DNA technology as an integral component of the pandemic response
given its potential for an outstanding safety profile and its
demonstrable thermostability. I am particularly grateful for the
confidence instilled in us by the U.S. Department of Defense, a
partnership to ensure that healthcare workers, frontline
responders, our elderly as well as our military servicemembers are
protected from COVID-19."
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 to confirm the more appropriate dosing
level(s) for each of three age groups (18-50 years, 51-64 years and
65 years and older) at high risk of SARS-CoV-2 exposure for the
subsequent Phase 3 efficacy evaluation.
The DoD has agreed to provide funding for both the Phase 2 and
Phase 3 segments of INNOVATE, in addition to the $71 million of funding previously announced in
June for the large-scale manufacture of the company's proprietary
next generation 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 INNOVATE 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, to confirm the
more appropriate dosing level 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 strives to ensure diversity in
enrollment, targeting specific populations that are working or
residing in environments with high 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.
The Phase 3 segment of the INNOVATE 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 into the cells of the skin. The company plans to
satisfy the remaining device questions during the conduct of Phase
2 segment and prior to the start of the Phase 3 segment of
INNOVATE. 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 dosing level(s) for each age
group 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. 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.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 Kaneka Eurogentec, 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.
About INO-4800
INO-4800 is INOVIO's prophylactic DNA vaccine candidate against
SARS-CoV-2, the novel coronavirus that causes COVID-19. INOVIO is
leveraging its extensive experience with INO-4700, its DNA vaccine
against another important coronavirus, the Middle East Respiratory
Syndrome (MERS), that is soon to be evaluated in a Phase 2 clinical
trial.
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 during transport or storage, which are important
considerations when preparing for 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), Kaneka Eurogentec,
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.