PLYMOUTH MEETING, Pa. and
SUZHOU, China, Aug. 9, 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 that it has received regulatory allowance for two
clinical trials investigating heterologous boosting with INO-4800,
its DNA vaccine candidate for COVID-19, through partner and
trial-sponsor Advaccine Biopharmaceuticals Suzhou Co., Ltd.
("Advaccine") together with Sinovac Biotechnology ("Sinovac"). The
studies will evaluate the safety, tolerability and immunogenicity
of heterologous prime-boost sequential immunizations using INO-4800
and CoronaVac®, an inactivated COVID-19 vaccine
developed by Sinovac and validated by the World Health Organization
(WHO) for emergency use.
China's Center for Drug
Evaluation of the National Medical Products Administration has
allowed the initiation of two Advaccine-sponsored open-label,
positive-control trials to evaluate the safety, tolerability, and
immunogenicity of mixed boosted regimens. Both studies, which will
be conducted in China, are
anticipated to begin this fall and will involve healthy adult
subjects 18 years of age or older.
The companies completed cross prime-boost pre-clinical animal
tests using INO-4800 and CoronaVac®, demonstrating that
the prime-boost strategy can stimulate high-level of antigen
specific binding antibodies, neutralizing antibodies by both
live-virus neutralization assay and hACE2 receptor blocking assay,
and antigen-specific T cell immune responses.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "With the increased challenge of the highly
contagious delta variant and other variants of concern around the
world, our work with Advaccine and Sinovac is more important than
ever. We are especially proud to expand on our partnership with
Advaccine to explore heterologous prime-boosting using INO-4800 to
protect more people in the continued fight against COVID-19. If
approved, we believe INO-4800 will be well-positioned to serve the
vaccine needs of the global community as both a primary and a
booster vaccine due to its tolerability, balanced cross-reactive
immune responses, and strong thermostability profile that does not
require cold or ultra-cold-chain transport."
Dr. Bin Wang, Founder and Chairman of Advaccine, said, "The
development of heterologous prime-boost strategies for COVID-19
vaccines with different mechanisms of action is an important
research direction in the field of vaccine applications. It
provides an efficient solution to synergistically enhance the
immunogenicity of vaccines, a key factor to fight against the
current increase in global COVID-19 cases and variants of concern.
We look forward to partnering with INOVIO and Sinovac on this
important effort building on our pre-clinical work, which found
that prime-boosting brings the advantages of two different vaccine
applications to produce an even stronger and more balanced immune
response."
INOVIO previously announced the expansion of its partnership
with Advaccine to jointly conduct the global Phase 3 segment of the
ongoing Phase 2/3 trial called INNOVATE (INOVIO
INO-4800 Vaccine Trial for Efficacy).
The global INNOVATE Phase 3 efficacy segment is being prepared in
multiple countries with an initial focus on Latin America, Asia and Africa. The primary endpoint will be
virologically confirmed COVID-19 cases. The 2.0 mg dose was
selected from the Phase 2 segment, where INO-4800 was shown to be
generally well-tolerated and immunogenic across all adult age
groups.
Recent analysis using clinical samples showed that INO-4800
maintained a robust T cell level against the delta variant, when
compared to T-cell responses from the original wildtype strain,
further demonstrating INO-4800's ability to generate CD8 T cells,
which INOVIO believes will be crucial in mitigating against rising
variants such as delta. This data complements the Phase 1 and 2
trial data for INO-4800, which highlighted key advantages across
INOVIO's DNA medicines platform – specifically, the ability to
induce a balanced immune response that includes engagement of both
T cells and B cells.
In parallel with INO-4800, INOVIO is also developing a novel,
pan-COVID, second-generation vaccine candidate, INO-4802, which is
designed to protect against current and future variants of concern.
In May 2021, INOVIO published a
manuscript in BioRxiv that demonstrated cross-reactive immune
responses against current and emerging viral variants using
INO-4802 as either a first-line vaccine or potentially as a booster
for individuals previously immunized with various wildtype
strain-matched vaccines. Specifically, INO-4802 induced potent
neutralizing antibodies and T cell responses against the original
wildtype strain as well as against alpha, beta, gamma, and delta
variants in pre-clinical models.
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. The company recently dosed
its first participant in a Phase 2 trial for INO-4700, its DNA
vaccine candidate for the prevention of Middle East Respiratory
Syndrome (MERS), a coronavirus that is 100 times deadlier than
COVID-19.
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 Inovio
believes are important considerations 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 programs for Middle East Respiratory
Syndrome, Lassa Fever and COVID-19 being developed under grants
from the Coalition for Epidemic Preparedness Innovations 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 met primary and secondary endpoints for all
evaluable subjects in REVEAL 1, in the first of two Phase 3 trials
for precancerous cervical dysplasia, demonstrating ability to
destroy and clear both high-grade cervical lesions and the
underlying high-risk HPV 16 and 18. INOVIO is also evaluating
INO-4800, a DNA vaccine candidate against COVID-19, in a Phase 2
clinical trial in the U.S., as well as Phase 2 trials in
China and South Korea. 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.
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 pre-clinical 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.
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SOURCE INOVIO Pharmaceuticals, Inc.