PR83839

PLYMOUTH MEETING, Pennsylvania, April 28, 2020 /PRNewswire=KYODO JBN/ --

- INO-4800 Phase 2/3 U.S. clinical trial being prepared to start this summer

- Parallel preclinical challenge studies ongoing

INOVIO (NASDAQ:INO) today announced that its Phase 1 U.S. clinical trial for

COVID-19 DNA vaccine INO-4800 is fully enrolled with all 40 healthy volunteers

receiving their first dose, with interim immune responses and safety results

expected in late June. The 40 healthy volunteers now enrolled at sites at the

University of Pennsylvania in Philadelphia, PA, and a clinic in Kansas City,

MO, will receive two doses of INO-4800 four weeks apart. The Phase 1 study is

designed to assess the safety profile and immunogenicity of INO-4800 in support

of advancing rapidly to a Phase 2/3 efficacy trial, which is planned to

potentially initiate this summer.

Dr. J. Joseph Kim, INOVIO's President and CEO, said, "We are extremely grateful

to the volunteers in Philadelphia and Kansas City who have stepped forward in

the midst of this deadly pandemic to help advance our promising DNA vaccine

against COVID-19. Without these volunteers, we would not be able to advance the

clinical study of INO-4800 at record speed and potentially provide INO-4800 as

a viable vaccine against the global COVID-19 pandemic."

Working in parallel with the clinical trial program in humans, INOVIO is

conducting several challenge studies in multiple animal models in

collaborations with some of the leading research groups in the world – as well

as working to scale up manufacturing of INO-4800. Preclinical data have shown

that INO-4800 resulted in promising immune responses across multiple

preclinical models, and the company is on track with its plan to deliver one

million doses by year-end for additional studies and potential emergency use,

pending appropriate regulatory guidance and external funding.

Lead Principal Investigator of the U.S. Phase 1 INO-4800 study Pablo Tebas,

M.D., infectious disease specialist and Professor of Medicine at the Hospital

of the University of Pennsylvania, said, "We anticipated rapid enrollment of

this study and the response at both our Philadelphia and Kansas City study

sites exceeded all expectations. We are profoundly inspired by this level of

volunteerism for the greater good as well as grateful to our dedicated team of

health care professionals for their tireless dedication to this worldwide

effort."

INOVIO has assembled a global coalition of collaborators, partners,

manufactures, 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 an anticipated one million doses of INO-4800 by year end and seeking

additional external funding and partnerships to scale up manufacturing

capacities to satisfy the urgent global demand for a safe and effective

vaccine. To date, 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.

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 rapidly designed

using INOVIO's proprietary DNA medicine platform 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 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, +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, 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.