PR84499

INOVIO Receives $71 Million Contract From U.S. Department of Defense To Scale Up Manufacture of CELLECTRA(R) 3PSP Smart Device and Procurement of CELLECTRA(R) 2000 for COVID-19 DNA Vaccine

PLYMOUTH MEETING, Pennsylvania, June 23, 2020 /PRNewswire=KYODO JBN/ --

  - U.S. Government will support the scale-up of INOVIO's proprietary

    intradermal DNA delivery device CELLECTRA(R) 3PSP to deliver INOVIO's

    COVID-19 vaccine

  - INOVIO to report on interim U.S. Phase 1 clinical trial results in

    late June

  - INOVIO preparing for U.S. Phase 2/3 efficacy study to begin this

    summer

INOVIO (NASDAQ:INO) today announced it has received $71 million funding from

the U.S. Department of Defense (DoD) to support the large-scale manufacture of

the company's proprietary CELLECTRA(R) 3PSP smart device and the procurement of

CELLECTRA(R) 2000 devices, which are used to deliver INO-4800 directly into the

skin.

Photo -

https://mma.prnewswire.com/media/1195022/INOVIOs_CELLECTRA_3PSP_Device.jpg

CELLECTRA(R) 3PSP is designed to deliver INO-4800 directly into the skin, where

the vaccine prompts the body's immune system to drive a robust immune response.

Interim results of U.S. Phase 1 clinical studies of INO-4800 will be available

later this month. A Phase 2/3 efficacy trial is planned to begin this summer

(July/August).

The DoD contract, from the JPEO-CRBND-EB through funding provided by the

Defense Health Program, builds upon two separate prior $5 million grants from

the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness

Innovations (CEPI), to accelerate the testing of CELLECTRA(R) 3PSP. Initial

development of this next generation CELLECTRA(R) 3PSP smart device began in

2019 with $8.1 million in funding from the medical arm of the U.S. Defense

Threat Reduction Agency's Medical CBRN Defense Consortium.

Dr. J. Joseph Kim, INOVIO's President and CEO, said, "INOVIO is very pleased to

receive this significant funding from the U.S. Department of Defense to

continue our rapid scale-up capacity for our breakthrough DNA medicines

delivery device CELLECTRA(R). We look forward to working closely with DoD,

JPEO-CBRND and JPL-CBRND-EB to provide much needed protection to DoD personnel

and their families through development of a safe and effective vaccine against

COVID-19. This next generation smart device leverages the efficacy delivery and

safety track record of an earlier version that has received CE mark

certification and has been used in clinical trials to safely dose more than

2,000 patients in over 7,000 administrations of INOVIO's DNA medicines. The

current DoD contract further supports INOVIO's large-scale production of

devices and arrays to deliver potentially hundreds of millions of doses of

INO-4800 next year to combat the global COVID-19 pandemic."

CELLECTRA(R) 3PSP is a small, portable, hand-held, user-friendly device that

runs on "AA" batteries. The device is designed to function reliably in

challenging environments and can be stockpiled in large quantities without

maintenance, characteristics that are critical in a pandemic situation.

INOVIO's San Diego device manufacturing facility has produced initial

quantities of the device, while also showing that the design and scale-up of

the manufacturing processes can be transferred to contract manufacturers in

order to further increase supply.

About the JPEO-CBRND

The Joint Program Executive Office for Chemical, Biological, Radiological and

Nuclear Defense is the Joint Service's lead for development, acquisition,

fielding and life-cycle support of chemical, biological, radiological and

nuclear defense equipment and medical countermeasures. As an effective

acquisition program, we put capable and supportable systems in the hands of the

service members and first responders, when and where it is needed, at an

affordable price. Our vision is a resilient Joint Force enabled to fight and

win unencumbered by a chemical, biological, radiological, or nuclear

environment; championed by innovative and state-of-the-art solutions. JPL-CBRND

Enabling Biotechnologies (EB) is an organization established for the purpose of

providing medical solutions, during a crisis, against future threats.

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate being developed 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

extensive experience working with coronaviruses and is the only company with a

vaccine in Phase 2 development for a related coronavirus that causes Middle

East Respiratory Syndrome (MERS).

INO-4800 is the only nucleic-acid based vaccine that is stable at room

temperature for more than a year and does not require to be frozen in transport

or storage, which are important factors when implementing mass immunizations.

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) and the

DoD. 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 is designed to ensure 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 7,000 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 treat and protect 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

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, including the availability and

timing of data from the company's ongoing Phase 1 clinical trial of INO-4800

and the company's plans and ability to outsource manufacturing of its delivery

devices to contract manufacturers. 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, our ability to

secure adequate third-party manufacturing resources for the production of our

product candidates, including the transfer of necessary processes, 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.