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INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference

PLYMOUTH MEETING, Pa. and SEOUL, South Korea, April 29, 2020 /PRNewswire=KYODO JBN/ --

- INO-4700 (GLS-5300) DNA vaccine demonstrates 100% binding and 92%

neutralizing antibody responses against MERS-CoV

- INO-4800 DNA vaccine for COVID-19 currently in Phase 1 trial utilizes

identical strategy targeting Spike protein and CELLECTRA intradermal delivery

INOVIO (NASDAQ:INO) and GeneOne Life Science (KSE:011000) today announced

interim data through week 16 from a Phase 1/2a trial of DNA vaccine INO-4700

(also called GLS-5300) for MERS coronavirus (MERS-CoV). Vaccine recipients

demonstrated strong antibody and T cell immune responses after 2 or 3 doses

with 0.6 mg of INO-4700, a DNA vaccine that targets the MERS-CoV Spike (S)

glycoprotein, delivered with intradermal CELLECTRA(R) device. The vaccination

regimen was well-tolerated with no vaccine-associated severe adverse events

(SAEs). The researchers at the Wistar Institute, Seoul National University

Hospital, and the International Vaccine Institute (IVI) collaborated on this

study with funding from IVI. These results were selected for an oral

presentation at the American Society of Gene & Cell Therapy (ASGCT) Conference

to be held virtually from May 12-15, 2020.

Dr. J. Joseph Kim, INOVIO's President & CEO, said, "The INO-4700 Phase 1/2a

clinical trial data demonstrates that our MERS DNA vaccine is able to generate

robust immune responses using INOVIO's intradermal CELLECTRA delivery system.

This exciting data provides a great foundation for the ongoing COVID-19 vaccine

advancement as it demonstrates the power of INOVIO's delivery system and the

strength of our coronavirus experience. As we have designed our COVID-19

vaccine INO-4800 using the same strategy as INO-4700, including the selection

of full length Spike protein as the target and the use of intradermal CELLECTRA

device, we are hopeful that the ongoing Phase 1 clinical trial with INO-4800

would generate similar clinical immune responses and safety data as we have

just reported for INO-4700."

Overall, for those receiving 0.6 mg of INO-4700, 88% demonstrated

seroconversion after a 2 dose regimen at 0 and 8 weeks, while for those

receiving a 3 dose regimen given at 0, 4 and 12 weeks, 84% seroverted after 2

doses and 100% after 3 doses, as measured by a binding antibody assay against

the full-length S protein (ELISA). Additionally, 92% of the vaccine recipients

in both groups displayed the ability to neutralize the virus using a

neutralization assay (EMC2012-Vero neutralization). Robust T cell responses

were observed in 60% of vaccine recipients after the 2 dose regimen and 84% of

those in the 3 dose group (ELISpot assay). Interestingly, a single dose of 0.6

mg of INO-4700 intradermal vaccination resulted in 74% binding antibody

response rate and 48% neutralization antibody response rate.

Dr. Jerome Kim, Director General of IVI, said, "IVI is pleased to join partners

in reporting these findings as a result of our collaboration in the world's

first vaccine candidate against MERS. These and subsequent clinical trials

could pave the way for accelerated development of a DNA vaccine against MERS."

This is the 2nd study of INO-4700 (GLS-5300) in a clinical trial, the first

being a 75-person study (MERS-001) of vaccine administered intramuscularly and

followed by electroporation at either 0.67, 2 or 6 mg. Notably in the MERS-001

study, there was no significant difference between dose levels and vaccine

induced immune responses were similar to those seen in recovered patients

following natural infection (Lancet Infectious Disease, 2019). INO-4700

vaccination has previously been shown to provide 100% protection against MERS

virus disease in a pathogenic monkey challenge model. INOVIO is planning to

advance INO-4700 into a Phase 2 clinical trial in the Middle East with a

previously announced funding of $56 million by the Coalition for Epidemic

Preparedness Innovations (CEPI).

About INOVIO's Global Coalition Advancing INO-4800

INOVIO has assembled a global coalition of collaborators, partners and funders

to rapidly advance INO-4800. R&D collaborators to date include the Wistar

Institute, the University of Pennsylvania, Université Laval, and the University

of Texas. INOVIO has partnered with Beijing Advaccine and the International

Vaccine Institute to advance clinical trials of INO-4800 in China and South

Korea, respectively. INOVIO is also assessing preclinical 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 also working with a team of contract manufacturers

including VGXI, Inc., Richter-Helm, and Ology Biosciences to produce one

million doses of INO-4800 by year-end and seeking additional external funding

and partnerships to scale up the manufacturing capacities to satisfy the urgent

global demand for a safe and effective vaccine. To date, CEPI, the Bill &

Melinda Gates Foundation, and the US Department of Defense have contributed

significant funding to the advancement and manufacturing of INO-4800.

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate created to protect against the novel

coronavirus SARS-CoV-2, which causes COVID-19. INO-4800 was designed using

INOVIO's proprietary DNA medicine platform rapidly after the publication of the

genetic sequence of the coronavirus that causes COVID-19. INOVIO has deep

experience working with coronaviruses and is the only company with a Phase 2a

vaccine for a related coronavirus that causes Middle East Respiratory Syndrome

(MERS).

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 diseases being developed under

grants from the Coalition for Epidemic Preparedness Innovations (CEPI). 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 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 demonstrated in clinical trials.

With more than 2,000 patients receiving INOVIO investigational DNA medicines in

more than 6,000 applications across a range of clinical trials, INOVIO has a

strong track record of rapidly generating DNA medicine candidates to meet

urgent global health needs.

About GeneOne Life Science

GeneOne Life Science Inc. is an international developer of DNA and RNA

vaccines, nucleic acid-based therapeutics, and small molecule therapies.

GeneOne sponsored the MERS-001 and MERS-002 clinical trials against MERS-CoV

and the ZIKA-001 and ZIKA-002 vaccine studies against the Zika virus. GeneOne's

research group has developed DNA vaccines and products to prevent and treat

incurable diseases as well as hematologic diseases, metabolic diseases, and

cancers. GeneOne is a recognized leader in the fight against Emerging

Infectious Diseases (EIDs) with a pipeline to address a number of pathogenic

organisms with a role in numerous international advisory committees regarding

vaccine development against EIDs. The company is headquartered in Seoul, South

Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary, located in

Texas, is the leading cGMP DNA plasmid manufacturing facility in the world for

the vaccine, cell therapy, and gene therapy industries. VGXI has manufactured

numerous DNA vaccines against EIDs including the GLS-5300/INO-4700 and INO-4800

vaccines for MERS-CoV and COVID-19, respectively. For more information, visit

www.genels.com and www.vgxii.com.

About the International Vaccine Institute (IVI)

The International Vaccine Institute (IVI) is a nonprofit inter-governmental

organization established in 1997 at the initiative of the United Nations

Development Programme (UNDP). Headquartered in Seoul, South Korea, IVI was the

first international organization hosted by Korea. IVI has 35 signatory

countries and the World Health Organization (WHO) on its treaty, including

Republic of Korea, Sweden and India as state funders.

Our mandate is to make vaccines available and accessible for the world's most

vulnerable people. We focus on infectious diseases of global health importance

such as cholera, typhoid, shigella, salmonella, schistosomiasis, Group A

Streptococcus, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as

antimicrobial resistance. For more information, please visit https://www.ivi.int

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market

precisely designed DNA medicines to potentially treat and protect people from

diseases associated with HPV, cancer, and infectious diseases. 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)/Department of Defense (DOD), GeneOne

Life Science/VGXI, HIV Vaccines Trial Network, International Vaccine Institute

(IVI), Medical CBRN Defense Consortium (MCDC), National Cancer Institute,

National Institutes of Health, National Institute of Allergy and Infectious

Diseases, Ology Bioservices, Plumbline Life Sciences, Regeneron, Richter-Helm,

Roche/Genentech, 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 DNA medicines, our expectations

regarding our research and development programs, as well as commercialization

activities, including the planned initiation and conduct of clinical trials,

the availability and timing of data from those trials and our commercialization

strategy and tactics. 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, 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 vaccines, our ability to support our pipeline of SynCon(R) active

immunotherapy and vaccine 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,

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.