INOVIO Doses First Subject in Phase 2 Segment of its INNOVATE Phase 2/3 Clinical Trial for INO-4800, its DNA Medicine to Prevent COVID-19
PR87079
PLYMOUTH MEETING, Pa., Dec. 7, 2020 /PRNewswire=KYODO JBN/ --
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(R) 3PSP and the procurement of CELLECTRA(R) 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(R). 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, +1 267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, +1 484-362-0076, 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.
SOURCE: INOVIO Pharmaceuticals, Inc.
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