PLYMOUTH MEETING, Pa.,
June 8, 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 an expansion of its previously announced
partnership with Advaccine Biopharmaceuticals Suzhou Co., Ltd.
("Advaccine") to jointly conduct a global Phase 3 segment of the
ongoing Phase 2/3 trial called INNOVATE (INOVIO
INO-4800 Vaccine Trial for Efficacy).
Together, the companies will evaluate the safety and efficacy of
INO-4800 in a two-dose regimen (2.0 mg), administered one month
apart, in a two-to-one randomization in subjects 18 years and older
across several countries, primarily in Latin America and Asia. The primary endpoint of the Phase 3
segment will be virologically confirmed COVID-19 disease. The 2.0
mg dose was selected from the Phase 2 segment, where INO-4800 was
shown to be generally well-tolerated and immunogenic in all tested
age groups.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "With most countries in the world currently
registering COVID vaccination rates of less than 10%, INOVIO and
Advaccine feel the urgency to advance INO-4800 into a global Phase
3 trial this summer. INOVIO is encouraged by our recently published
Phase 2 data for INO-4800, which showed the vaccine to be
well-tolerated and immunogenic in all tested age groups. In a
previously announced study, INO-4800 was also found to generate
broad cross-reactive immune responses against tested SARS-CoV-2
variants of concern, which may enable it to provide greater
protection for more people globally."
Dr. Kim continued, "We believe that INO-4800, if
approved, will be well-positioned to serve the vaccine needs of the
global community. Based on trial results to date, this vaccine has
shown to be well-tolerated; produces balanced neutralizing
antibodies and favorable T cell response (CD8 and CD4) and is easy
to administer. It is uniquely positioned to support vaccine rollout
to underserved countries globally with a strong thermostability
profile that is stable at room temperature for more than a year and
does not require cold or ultra-cold-chain transport. In addition to
the potential approval as a primary vaccine, INO-4800 also has the
potential to be used as a booster vaccine since the early clinical
data supports that INO-4800 can be safely re-administered."
Founder and Chairman of Advaccine, Dr. Bin Wang said,
"The expansion of our partnership with INOVIO has a lot of
synergy and we are excited about the global Phase 3 trial of
INO-4800. We look forward to bringing a well-tolerated and
immunogenic COVID-19 vaccine to more people around the world.
Advaccine has built up large scale GMP manufacturing facilities of
DNA vaccine and recently obtained the vaccine manufacturing
permit from Chinese regulatory authorities, becoming one of a few
companies in China that have the
license. We are working to expand our manufacturing capacities
further, in order to meet the unmet global need for nucleic
acid-based COVID-19 vaccines."
Under their expanded collaboration, INOVIO and Advaccine intend
to share equally, subject to specified limitations and conditions,
the total cost of the planned global Phase 3 trial, which is
estimated to be approximately $100
million. The expanded partnership is an extension of an
existing relationship between the two companies, including an
exclusive agreement announced in January
2021 under which Advaccine has the exclusive rights to
develop, manufacture and commercialize INO-4800 within Greater China, inclusive of mainland
China, Hong Kong, Macao and Taiwan. Under the expanded agreement,
Advaccine obtains rights to additional Asian countries outside of
Greater China. Advaccine has
extensive experience in co-development of INO-4800 with INOVIO,
including sponsoring both Phase 1 and Phase 2 clinical trials in
China for INO-4800.
The global Phase 2/3 trial builds upon INOVIO's Phase 2 segment,
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 published as 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.
In addition to the initiation of the clinical trial itself,
INOVIO is in discussions with several countries which are expected
to provide clinical trial sites, regarding advanced market
contracts to potentially supply INO-4800 upon respective regulatory
approvals in those countries.
About the INO-4800 "INNOVATE" Phase 2/3 Clinical
Trial
The Phase 2 segment of INNOVATE Phase 2/3 trial was designed to
evaluate the safety, tolerability and immunogenicity of INO-4800 in
a two-dose regimen (1.0 mg or 2.0 mg) in a
three-to-one-randomization to receive either INO-4800 or placebo in
three age groups (18-50 years, 51-64 years and 65 years and older).
The Phase 2 data showed that INO-4800 was well-tolerated and
immunogenic in all tested age groups, and the 2.0 mg dose was
selected to advance into the Phase 3 segment of the trial.
The global Phase 3 segment of the trial intends to enroll
healthy men and non-pregnant women 18 years of age and older, to
evaluate the efficacy of INO-4800 (2.0 mg) in a two-dose regimen
based on the Phase 2 dose-confirmation data. The trial will be
predominantly conducted in vaccine underserved countries in
Latin America and Asia. Participants will be enrolled in a
two-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 INO-4800
INO-4800 is INOVIO's DNA vaccine candidate 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 DNA vaccine candidate for
a related coronavirus that causes Middle East Respiratory Syndrome
(MERS).
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
37o 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 of 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 and focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 that are being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. DNA medicines are composed of precisely
designed 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. 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 the relative
speed at which 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, and tolerability
that have been observed in clinical trials.
With more than 3,000 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 the 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 is the first DNA medicine to achieve efficacy
endpoints in a Phase 3 clinical trial, REVEAL 1, for the treatment
of precancerous cervical dysplasia caused by HPV-16 and/or HPV-18.
VGX-3100 also demonstrated positive Phase 2 efficacy results in
separate trials evaluating the treatment of precancerous vulvar
dysplasia and anal dysplasia. 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. 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 commercialize DNA medicines, our expectations regarding our
research and development programs, including the planned initiation
and conduct of preclinical 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 March 31, 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.
View original
content:http://www.prnewswire.com/news-releases/inovio-expands-partnership-with-advaccine-to-conduct-global-phase-3-efficacy-trial-of-covid-19-dna-vaccine-candidate-ino-4800-301307352.html
SOURCE INOVIO Pharmaceuticals, Inc.