PR83262

PLYMOUTH MEETING, Pennsylvania, March 12, 2020 /PRNewswire=KYODO JBN/ --

INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it has received

a new $5 million grant from the Bill & Melinda Gates Foundation to accelerate

the testing and scale up of CELLECTRA(R) 3PSP proprietary smart device for the

intradermal delivery of INO-4800, a DNA vaccine for COVID-19. INO-4800 is in

preclinical studies and is planned to advance into Phase 1 clinical trials in

the U.S. in April with up to $9 million funding from CEPI. INOVIO plans to

accelerate the testing and scale up of the CELLECTRA 3PSP devices to support

large scale manufacturing of INO-4800 doses by the end of 2020.

The next generation CELLECTRA 3PSP device is designed specifically for a COVID-19 type

pandemic scenario. It is a small, portable, hand-held, user-friendly device that runs on readily

available "AA" batteries. This allows for stockpiling of the device in quantity without maintenance.

It is easy to use and is based on our current device with extensive history (over 6,000

administrations)  which has received the CE mark and has an acceptable safety profile.

The streamlined design also allows it to be readily produced at reduced costs and large scale.

The device has been designed with reliability, challenging environments, user

needs and ease of large scale manufacturing in mind. INOVIO's San Diego Device

Manufacturing facility will build initial quantities and demonstrate the design

and scale up of manufacturing processes which can then be transferred to

additional contract manufacturers for increased capacity. Initial development

of CELLECTRA 3PSP was started in 2019 with $8.1 million funding from the

medical arm of the U.S. Defense Threat Reduction Agency (DTRA)'s Medical CBRN

Defense Consortium. The new funding will help to accelerate the testing and

completion of the device development and scale up to combat the COVID-19 disease.

Dr. J. Joseph Kim, INOVIO's President & CEO, said, "INOVIO is grateful to the

Bill & Melinda Gates Foundation for their continued investment in INOVIO's DNA

medicines platform and for their support for DNA vaccines to potentially protect

those at risk globally given the current COVID-19 outbreak. Our team of vaccine 

experts are working around the clock to advance INO-4800 and we look forward to attracting

additional partnerships to expedite its development to meet this urgent global health need."

INOVIO aims to deliver one million doses of INO-4800 and devices to support

them by year end with existing resources and capacity with the appropriate

support from its funding partners. INOVIO also is working to scale up both

INO-4800 and CELLECTRA 3PSP devices to potentially make available millions of

doses to combat this outbreak.

INOVIO's DNA medicine platform is ideally suited to rapidly respond 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. INO-4700 is the only MERS-CoV vaccine in Phase 1/2a setting, 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 previous CEPI funding of up to $56 million and

from other collaborators and partners.

About INOVIO's DNA Medicines

INOVIO has 15 DNA medicine clinical programs currently in development focused

on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses

MERS and COVID-19 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). CELLECTRA(R) uses a brief electrical pulse to open

small pores in the cell reversibly to allow the plasmids to enter, overcoming a

key limitation of other DNA and mRNA approaches. Once inside the cell, the

plasmids are used by the cell's own machinery to generate coded antigens, which

then stimulate an immune response, thereby strengthening the body's own natural

defense mechanisms. Administration with the CELLECTRA device ensures that the

DNA medicine is delivered directly into the body's cells, where it can go to

work immediately mounting 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 constructed 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 Pharmaceuticals, Inc.

INOVIO is a biotechnology company focused on rapidly bringing to market

precisely designed DNA medicines to treat, cure, 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, demonstrated it 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,

90% 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 MERS and COVID-19.

Partners and collaborators include Advaccine, ApolloBio Corporation, AstraZeneca,

The Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations (CEPI),

Defense Advanced Research Projects Agency, GeneOne Life Science, HIV Vaccines Trial

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

National Institutes of Health, National Institute of Allergy and Infectious Diseases,

Plumbline Life Sciences, Regeneron, 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.

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 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, 2018, our Quarterly Report

on Form 10-Q for the quarter ended September 30, 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.

CONTACTS:

Investors: Ben Matone, +1 484-362-0076, ben.matone@inovio.com

Media: Jeff Richardson, +1 267-440-4211, jrichardson@inovio.com

SOURCE: Inovio Pharmaceuticals, Inc.