Inovio Accelerates Timeline for COVID-19 DNA Vaccine INO-4800

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PLYMOUTH MEETING, Pennsylvania, March 3, 2020 /PRNewswire=KYODO JBN/ --

- Human Trials Planned for April; One Million Doses Expected by Year End

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced an accelerated

timeline for developing its DNA vaccine INO-4800 to address COVID-19, the

respiratory infection the World Health Organization (WHO) has designated a

Public Health Emergency of International Concern of the highest level.

According to WHO, approximately 89,000 cases have been reported globally with

more than 3,000 deaths.

Dr. J. Joseph Kim, Inovio's President & CEO, shared this accelerated timeline

at the U.S. Coronavirus Task Force meeting at the White House on March 2. Dr.

Kim said, "Inovio is the leader in coronavirus vaccine development and the only

company with a Phase 2 vaccine for a related coronavirus that causes Middle

East Respiratory Syndrome (MERS). Using our modern DNA medicines platform,

we designed our DNA vaccine INO-4800 in three hours after the publication of the

genetic sequence of the novel coronavirus that causes COVID-19."

Dr. Kim continued, "We immediately began preclinical testing and small-scale

manufacture and have already shared robust preclinical data with our public and

private partners. We plan to begin human clinical trials in the U.S. in April and

soon thereafter in China and South Korea, where the outbreak is impacting

the most people. We plan on delivering one million doses by year end with

existing resources and capacity. However, we will need additional resources to

scale up to make enough doses to help protect Americans from COVID-19 as well

as to lead global efforts to curtail this virus."

Inovio's COVID-19 DNA Vaccine Development Timeline

December 31, 2019 Inovio scientists learn about a novel coronavirus (SARS-

                                CoV-2) which caused an outbreak of respiratory disease

                                in Wuhan, China, now referred to as COVID-19

January 10, 2020        Chinese researchers share the genetic sequence of the

                                 novel coronavirus

                                 Inovio designs DNA vaccine INO-4800 in three hours

                                 after receiving the genetic sequence using its

                                 proprietary DNA medicines platform technology

                                 INO-4800 was designed to precisely match the DNA

                                 sequence of the virus

January 10 to              Inovio scientists race to manufacture INO-4800 and

January 23, 2020        begin preclinical testing

January 23, 2020        Inovio receives a grant of up to $9 million from the

                                Coalition for Epidemic Preparedness Innovations (CEPI)

                                to fund ongoing preclinical and initial clinical

                                development of INO-4800

January 23 to              Preclinical testing continues, with immune responses

February 29, 2020       generated in animal models; human clinical trial

                                 designs developed

March 2020              Ongoing preclinical studies; human clinical trial

                               designs finalized; 3,000 human trial doses prepared for

                               clinical trials in the U.S., China, and South Korea;

                               large-scale manufacturing plans developed

April 2020              Human clinical trials begin in 30 healthy volunteers in

                             the U.S. Human clinical trials to begin in China and

                             South Korea shortly thereafter

Fall 2020               Human clinical trial results presented/published

End of 2020           1 million doses of INO-4800 COVID-19 DNA vaccine

                             produced for further trials or emergency use

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 COVID-19

under a grant 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 uses a brief electrical pulse to open

small pores in the cell reversibly to allow the plasmids to enter. Once inside

the cell, the plasmids begin replicating, thereby strengthening the body's own

natural response 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 are not

interfering with or changing in any way an individual's own DNA.

The advantages of Inovio's DNA medicine platform are how fast DNA medicines can

be created and manufactured, the stability of the products which do not require

freezing in storage and transport, and their robust immune response as well as

safety and tolerability.

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 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

safely produce a robust immune response to destroy and clear high-risk HPV 16

and 18, which are responsible for 70% of cervical cancer, 90% of anal cancer

and 69% of vulvar cancer. In addition to HPV, Inovio's optimized plasmid design

and delivery technology have been demonstrated to consistently activate robust

and fully functional T cell and antibody responses against targeted cancers and

pathogens. Inovio's most advanced clinical program, VGX-3100, is in Phase 3

development for the treatment of HPV-related cervical pre-cancer. Also in

development are Phase 2 immuno-oncology programs targeting HPV-related cancers,

GBM, and prostate cancer, as well as externally funded vaccine development

programs in Zika, MERS, Lassa, HIV, 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, Inovio, +1 484-362-0076, ben.matone@inovio.com

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

SOURCE: Inovio Pharmaceuticals, Inc.