Country for PR: United States
Contributor: PR Newswire New York
Friday, December 11 2020 - 00:00
INOVIO and Advaccine Announce First Dosing of Subject in Phase 2 Clinical Trial for COVID-19 DNA Vaccine Candidate INO-4800 in China
PLYMOUTH MEETING, Pa. and SUZHOU, China, Dec. 10, 2020 /PRNewswire-AsiaNet/ --

  -- Dosing marks a key milestone for INO-4800 in China and its second 
     Phase 2 clinical trial globally

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 

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, 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(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 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.

Source - INOVIO Pharmaceuticals, Inc.