INOVIO Expands Partnership with Advaccine to Conduct Global Phase 3 Efficacy Trial of COVID-19 DNA Vaccine Candidate, INO-4800
PR89975
PLYMOUTH MEETING, Pa., June 8, 2021 /PRNewswire=KYODO JBN/ --
-- Phase 3 efficacy trial planned to commence this summer in areas of the
world underserved by vaccines
-- News follows recently announced Phase 2 data, which showed INO-4800 to
be well-tolerated and immunogenic in all age groups
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(R). The CELLECTRA(R) 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.
Source - INOVIO Pharmaceuticals, Inc.
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