PLYMOUTH MEETING, Pa. and
SUZHOU, China, Jan. 4, 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 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 that they have entered into a
collaboration and license agreement for COVID-19 DNA vaccine
candidate INO-4800.
Under the collaboration and license agreement, Advaccine will
have the exclusive right to develop, manufacture and commercialize
INO-4800 within Greater China,
inclusive of Mainland China, Hong
Kong, Macao, and
Taiwan. Advaccine will license its
plasmid manufacturing process for use with INO-4800 and other
INOVIO pipeline product candidates to INOVIO with the right to
sublicense to INOVIO's manufacturing partners. Additionally,
Advaccine will provide its clinical data to INOVIO in support of
INOVIO's global INO-4800 regulatory filings and INOVIO will provide
its INO-4800 clinical data for Advaccine to incorporate into its
marketing applications in Greater
China. Advaccine will make to INOVIO an upfront payment of
$3.0 million as well as pay an
aggregate of $108.0 million upon the
achievement of specified development and sales-based milestones for
INO-4800 in Greater China. INOVIO
will be entitled to receive a royalty equal to a high single-digit
percentage of annual net sales in each region within Greater China.
Dr. J. Joseph Kim, President and
Chief Executive Officer of INOVIO, said, "INOVIO's partnership with
Advaccine enables us to leverage their deep expertise, capabilities
and network across the region – making it possible to rapidly
produce and if and when approved, distribute our vaccine candidate
to more people across Greater
China. This agreement also provides INOVIO with an Asian
manufacturing partner with a near-term focus on INO-4800 and a
long-term manufacturing resource potentially for other INOVIO
products. We are grateful for Advaccine joining our global
manufacturing coalition as a dedicated resource for Greater China and look forward to our
continued partnership in the fight against COVID-19."
Dr. Bin Wang, Founder and Chairman of Advaccine, said, "We are
proud to build upon our current partnership with INOVIO and join
their global manufacturing consortium. Advaccine will leverage its
innovative large-scale DNA plasmid manufacturing process developed
over years -- our GMP manufacturing facility in Suzhou has the
capacity to produce over one hundred million doses of DNA vaccine
per year. Given the strong safety profile and robust immune
responses observed in the U.S. and China clinical trials of INO-4800, we are
confident in the vaccine candidate and are fully committed to the
manufacturing of INO-4800 for Greater
China. INO-4800 is projected to be stable at room
temperature for over a year, at 37oC for more than a
month, and with a five-year projected shelf life at normal
refrigeration temperature. INO-4800 does not need to be frozen
during transport or storage – a critical element when considering
the feasibility of distribution in Greater China and globally."
INOVIO and Advaccine have been working together to advance the
clinical development of INO-4800 in China, having all 640 subjects dosed for the
first vaccination in Phase 2 clinical trial in China. The Phase 2 clinical trial of INO-4800
in China has enrolled both adults
who are 18-59 years old 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, similar to the independently run Phase 2 segment of
INOVIO's Phase 2/3 clinical trial for INO-4800 in the U.S, called
INNOVATE (INOVIO INO-4800 Vaccine Trial
for Efficacy).
INOVIO also recently announced it has started dosing of subjects
in the Phase 2 segment of INNOVATE. For more information about the
INNOVATE 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 planned
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 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 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, manufacture and commercialize DNA medicines, in particular
our vaccine candidate INO-4800 in Greater
China in collaboration with Advaccine, our expectations
regarding our research and development programs, including the
planned initiation and conduct of the Phase 2/3 clinical trial of
INO-4800 in the United States and
a Phase 2 clinical trial in China,
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.