PR89162

PLYMOUTH MEETING, Pa., April 23, 2021 /PRNewswire=KYODO JBN/ --

  -- Given universal eligibility and broad availability of COVID-19 vaccines

     in the U.S., DoD JPEO-CBRND has notified INOVIO that it will discontinue

     funding for the Phase 3 INO-4800 trial

  -- INOVIO adjusts INO-4800 clinical development strategy to focus on

     global unmet COVID-19 vaccine needs

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market

precisely designed DNA medicines to treat and protect people from infectious

diseases, cancer, and HPV-associated diseases, today announced that it is

planning for a predominantly ex-U.S. Phase 3 trial for its COVID-19 vaccine

candidate, INO-4800. Given the increasing availability of vaccines authorized

for emergency use, the Department of Defense Joint Program Executive Office for

Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in

coordination with the Office of the Assistant Secretary of Defense for Health

Affairs (OASD(HA)) and the Defense Health Agency (DHA), will discontinue

funding for the Phase 3 segment of the INNOVATE trial, while continuing to fund

the completion of the ongoing Phase 2 segment. In correspondence, JPEO informed

INOVIO: "The decision results from the changing environment of COVID-19 with

the rapid deployment of vaccines. This decision is not a reflection of the

awardee or product, rather a fast-moving environment associated with the former

Operation Warp Speed on decisions related to future products."

This decision does not impact other work that INOVIO does with the US

government and is neither a result of the partial clinical hold nor a

reflection of the data generated to date for INO-4800 vaccine. With existing

global collaborators such as INOVIO's China partner, Advaccine, and the

International Vaccine Institute (

https://c212.net/c/link/?t=0&l=en&o=3139539-1&h=2180558442&u=https%3A%2F%2Fwww.ivi.int%2F&a=International+Vaccine+Institute

) (IVI,) the company is planning for a predominantly ex-US global Phase 3 trial

based on upcoming evaluation of Phase 2 safety and immunogenicity data. INOVIO

continues to evaluate its pan-COVID variant vaccine, INO-4802, to protect

against current and future variants of concern, as well as assessing boosting

capabilities for INO-4800. INOVIO remains well-positioned to support both

pandemic and endemic vaccine needs with INO-4800 and INO-4802. INOVIO and its

partners and collaborators look forward to being part of the global solution to

prevent the spread of COVID-19 – including both current and future variants.

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate against SARS-CoV-2, the coronavirus

that causes COVID-19. INOVIO has extensive experience working with

coronaviruses and was the first company to initiate a Phase 2a trial for

INO-4700, a DNA vaccine candidate for a related coronavirus that causes Middle

East Respiratory Syndrome (MERS).

Composed of an optimized DNA plasmid, INO-4800 is delivered directly into cells

in the body via a proprietary smart device to produce a robust and tolerable

immune response. INO-4800 is the only nucleic-acid based vaccine that is stable

at room temperature for more than a year, at 37°C for more than a month, has a

five-year projected shelf life at normal refrigeration temperature and does not

need to be frozen during transport or storage – all of which are important

considerations when preparing for 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

U.S. Department of Defense. 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(R) 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(R) 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 observed in clinical trials.

With more than 3,000 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 is the first DNA medicine to achieve efficacy endpoints in a

Phase 3 clinical trial, REVEAL 1, for the treatment of precancerous cervical

dysplasia caused by HPV-16 and/or HPV-18. VGX-3100 also demonstrated positive

Phase 2 efficacy results in separate trials evaluating the treatment of

precancerous vulvar dysplasia and anal dysplasia. 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)/Joint Program Executive Office for Chemical, Biological, Radiological

and Nuclear Defense (JPEO-CBRND)/Department of Defense (DoD), HIV Vaccines

Trial Network, International Vaccine Institute (IVI), Kaneka Eurogentec,

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, Thermo Fisher Scientific,

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 and commercialize 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, and our

ability to successfully manufacture and produce large quantities of our product

candidates if they receive regulatory approval. 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, our ability to secure sufficient manufacturing capacity to mass

produce our product candidates, 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 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, 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.