PLYMOUTH MEETING, Pa.
and SUZHOU, China,
Dec. 10, 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, and Advaccine
Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine"), an emerging
biotech company with next-generation technology in vaccines – both
preventive and therapeutic, today announced the successful dosing
of its first subject in its Phase 2 clinical trial for COVID-19 DNA
vaccine candidate, INO-4800, in China. The Phase 2 clinical trial being
conducted in China is independent
of the INNOVATE Phase 2/3 clinical trial of INO-4800 being advanced
in the U.S. and will enroll approximately 640 participants who are
18 years or older. Advaccine is conducting and funding the Phase 2
trial in China, which is expected
to fully enroll by the end of this month.
Dr. J. Joseph Kim, President and
CEO of INOVIO, said, "We have accelerated the development of
INO-4800, our DNA vaccine candidate for COVID-19, in China by working together and leveraging
Advaccine's expertise with Chinese regulatory authorities and
clinical trial management. We are grateful for our collaboration
with Advaccine and its founder Dr. Bin Wang, China's premier DNA vaccine expert and
Emeritus Professor from Fudan University. Our teams are pleased
with the progress to date and our ability to accelerate our
clinical work in China with the
goal of developing and delivering a safe, tolerable, effective and
lasting vaccine for COVID-19.
Dr. Bin Wang, Founder of Advaccine, said, "We are truly grateful
for Advaccine to co-develop INO-4800 against COVID-19 with INOVIO's
team around the clock since January of this year, having maintained
a very close collaboration together. INOVIO's great advantage of
rapid DNA plasmid and delivery technologies are very important to
the success of this vaccine candidate. After the completion of
dosing for Phase 1 trial subjects at Huashan Hospital in
Shanghai, China, with regulatory
approval, Advaccine quickly launched the Phase 2 clinical trial
with Jiangsu Provincial CDC team. With the support of Fengcai ZHU,
MD the principle investigator and a well-known vaccine clinical
professor and his excellent team members as well as advanced
clinical trial infrastructure in Jiangsu
Province, I believe we can achieve China Phase 2 enrollment
target of 640 subjects by the end of 2020."
INOVIO and Advaccine have been working together to advance the
clinical development of INO-4800 in China. The Phase 2 clinical trial of INO-4800
in China will enroll both 18-59
years old adults and older adults (60 years and older) with the
primary endpoints of evaluating safety and immunogenicity within
the Chinese population. The dosing regimen involves two
vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing
levels and is similar to the Phase 2 segment of Phase 2/3 clinical
trial in U.S. This trial in China
will provide valuable insights on INO-4800 safety and
immunogenicity profile to support further evaluation of this
vaccine candidate.
INOVIO recently announced it has dosed the first subjects in the
Phase 2 segment of its Phase 2/3 clinical trial for INO-4800 in the
U.S., called INNOVATE (INOVIO INO-4800 Vaccine
Trial for Efficacy). For more information about the
clinical trial, see www.clinicaltrials.gov, identifier
NCT04642638.
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 clinical 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 (in a planned total of 400 subjects) 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 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). 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 S.A, 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 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 an optimized DNA plasmid, INO-4800 is delivered
directly into cells in the body via a proprietary smart device to
produce a robust, safe and tolerable 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 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, 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 Advaccine
Advaccine Biopharmaceuticals Suzhou Co., Ltd. ("Advaccine") is
an emerging clinical stage immunotherapy company pioneering novel
preventive and therapeutic vaccines against infectious diseases,
cancers and autoimmune diseases. Advaccine exploits a wide range of
vaccine applications, with innovative antigen technologies, its
adjuvant platform and along with a cellular immunity assessment
platform for the swift development of novel vaccine and
immunotherapeutic candidates. Through years of innovative
preclinical and clinical research, Advaccine has successfully built
a broad portfolio of vaccine candidates including a preventive
vaccine based on a novel adjuvant targeting respiratory syncytial
virus (RSV) infection in the elderly and infants, an
immunotherapeutic vaccine against chronic hepatitis B (CHB), and
also immunotherapeutic vaccine candidates against autoimmune
diseases and various cancers. Based on its deep expertise in
vaccine research and in-house large-scale manufacturing
capabilities, Advaccine has been able to bring several vaccine
candidates to clinical stages and ready for late stage clinical
testing and commercial launch in the near future.
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.