PR84094

PLYMOUTH MEETING, Pennsylvania, May 20, 2020 /PRNewswire=KYODO JBN/ --

-  Publication in Nature Communications demonstrates generation of robust

neutralizing antibodies and T cell responses against SARS-CoV-2

-  Preliminary safety and immune responses data from Phase 1 clinical trial

expected in June

-  Multiple animal challenge study data expected in coming weeks

-  Phase 2/3 efficacy trial planned to start in July/August pending regulatory

approval

INOVIO (NASDAQ:INO) today announced the publication of the preclinical study

data for IN0-4800, its COVID-19 DNA vaccine, demonstrating robust neutralizing

antibody and T cell immune responses against coronavirus SARS-CoV-2. The study

was published in the peer-reviewed journal Nature Communications titled,

"Immunogenicity of a DNA vaccine candidate for COVID-19" by INOVIO scientists

and collaborators from The Wistar Institute, the University of Texas, Public

Health England, Fudan University, and Advaccine.

Dr. Kate Broderick, INOVIO's Senior Vice President of R&D and the Team Lead for

COVID-19 vaccine development, said, "These positive preclinical results from

our COVID-19 DNA vaccine (INO-4800) not only highlight the potency of our DNA

medicines platform, but also build on our previously reported positive Phase

1/2a data from our vaccine against the coronavirus that causes MERS, which

demonstrated near-100% seroconversion and neutralization from a similarly

designed vaccine INO-4700. The potent neutralizing antibody and T cell immune

responses generated in multiple animal models are supportive of our currently

on-going INO-4800 clinical trials."

INO-4800 targets the major surface antigen Spike protein of SARS-CoV-2 virus,

which causes COVID-19 disease. The studies demonstrated that vaccination with

INO-4800 generated robust binding and neutralizing antibody as well as T cell

responses in mice and guinea pigs. Importantly, the authors demonstrated virus

neutralizing activity using three separate neutralization assays testing the

vaccine's ability to generate antibodies which can block virus infection by: 1)

an assay using live SARS-CoV-2 viruses; 2) an assay using a pseudo-virus assay,

where another virus displays the SARS-CoV-2 Spike protein; and, 3) a novel

high-throughput surrogate neutralization assay measuring the ability of

INO-4800-induced antibodies to block SARS-CoV-2 Spike binding to the host ACE2

receptor. Study authors also detected these antibodies in the lungs of the

vaccinated animals which could be important in providing protection from

SARS-CoV-2. In addition, high levels of Spike-specific T cell responses were

observed with INO-4800 vaccination, which could be important in mediating

protection from the virus infection. Collectively, this preclinical dataset

demonstrates that INO-4800 is a promising COVID-19 vaccine candidate against

this emerging disease threat.

Dr. J. Joseph Kim, INOVIO's President & CEO, said, "INOVIO and our

collaborators are working diligently to advance INO-4800 to help fight the

current pandemic. We are planning to utilize these positive preclinical results

along with our upcoming animal challenge data and safety and immune responses

data from our Phase 1 studies to support rapidly advancing this summer to a

large, randomized Phase 2/3 clinical trial."

INOVIO's swift progress in COVID-19 vaccine development is based on the ideal

suitability of its DNA medicine platform to rapidly develop vaccines against

emerging viruses with pandemic potential. INOVIO was the first to advance its

DNA vaccine INO-4700 against MERS-CoV, a related coronavirus, into evaluation

in humans in a collaboration with GeneOne Life Science and the Walter Reed Army

Institute of Research. INO-4700 is the only MERS-CoV vaccine with positive data

from a Phase 1/2a clinical trial, and INOVIO is currently preparing to initiate

a larger Phase 2 vaccine trial for INO-4700 in the Middle East where most MERS

viral outbreaks have occurred. These efforts are supported by CEPI funding.

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 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, the University of Texas, Fudan

University and the Laval University. INOVIO has partnered with 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 BioLogics, and Ology

Biosciences to produce INO-4800 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, the Coalition for

Epidemic Preparedness Innovations (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 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

intradermally or intramuscularly 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 with

potential to meet urgent global health needs.

About INOVIO

INOVIO is a biotechnology company focused on rapidly bringing to market

precisely designed DNA medicines to protect and treat 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)/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, the Parker Institute for Cancer Immunotherapy,

Plumbline Life Sciences, Regeneron, Richter-Helm BioLogics, 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, +1-267-440-4211, jrichardson@inovio.com

Investors: Ben Matone, +1-484-362-0076, 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, including the planned

initiation and conduct of preclinical studies and clinical trials, and the

availability and timing of data from those studies and trials. Actual events or

results may differ from the expectations set forth herein as a result of a

number of factors, including uncertainties inherent in pre-clinical 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 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 March 31, 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.