Country for PR: United States
Contributor: PR Newswire New York
Tuesday, January 05 2021 - 00:00
INOVIO and Advaccine Announce Exclusive Partnership To Commercialize COVID-19 DNA Vaccine Candidate, INO-4800, in Greater China
PLYMOUTH MEETING, Pa. and SUZHOU, China, Jan. 4, 2021 /PRNewswire-AsiaNet/ --

- Partnership Adds Asian Manufacturing Resource to INOVIO's Global 
Manufacturing Consortium for INO-4800

- INO-4800 Phase 2 Trial Fully Enrolled in China

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, 
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(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, 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(R) 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.


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


Media: Jeff Richardson, 267-440-4211,
Investors: Ben Matone, 484-362-0076,

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.

SOURCE  INOVIO Pharmaceuticals, Inc.