PR87163

PLYMOUTH MEETING, Pa. and SUZHOU, China, Dec. 10, 2020 /PRNewswire=KYODO JBN/ --

  -- 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

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(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.

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.

Source - INOVIO Pharmaceuticals, Inc.