PR92917

PLYMOUTH MEETING, Pa., Nov. 9, 2021 /PRNewswire=KYODO JBN/ --

- FDA Lifts Partial Clinical Hold on INNOVATE Phase 3 Segment

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

precisely designed DNA medicines to help protect people from infectious

diseases and treat cancer and HPV-associated diseases, today announced that the

U.S. Food and Drug Administration (FDA) provided authorization to proceed for

INOVIO's INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800,

in the U.S. The FDA has lifted the partial clinical hold following the FDA's

review of additional non-clinical, clinical, and device information provided by

INOVIO.

Dr. J. Joseph Kim, INOVIO's President and CEO, said, "I want to recognize and

express my appreciation to my INOVIO colleagues for their hard work throughout

this process. We are pleased to have the opportunity for U.S. clinical trial

participants to potentially contribute to the enrollment in our INNOVATE Phase

3 segment. Today's U.S. announcement builds on our intensive global efforts in

India, Brazil, Philippines, Mexico, Colombia, and Thailand where we have

received authorizations to date."

INOVIO is partnering with Advaccine Biopharmaceuticals Suzhou Co., Ltd. to

conduct the INNOVATE Phase 3 segment in multiple countries in the Americas,

Asia, and Africa. The global Phase 3 segment of INNOVATE will evaluate the

efficacy of INO-4800 in a two-dose regimen (2.0 mg per dose), administered one

month apart, in a 2-to-1 randomization in men and non-pregnant women 18 years

of age and older. The primary endpoint of this case-driven Phase 3 trial is

virologically confirmed symptomatic COVID-19.

About INO-4800

INO-4800, INOVIO's DNA vaccine candidate against SARS-CoV-2, is composed of a

precisely designed DNA plasmid that is injected intradermally followed by

electroporation using a proprietary smart device, which delivers the DNA

plasmid directly into cells in the body and is intended to produce a

well-tolerated immune response. As one of the only nucleic-acid based vaccines

that is stable at room temperature for more than a year, at 37 degrees C for

more than a month, has a five-year projected shelf life at normal refrigeration

temperatures and does not need to be frozen during transport or storage,

INO-4800 is anticipated to be well-positioned for a primary series immunization

as well as a booster.

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 company

to have clinically demonstrated that a DNA vaccine candidate 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 therapeutic

candidate VGX-3100 met primary and secondary endpoints for all evaluable

subjects in REVEAL 1, the first of two Phase 3 trials for precancerous cervical

dysplasia, demonstrating ability to destroy and clear both high-grade cervical

lesions and the underlying high-risk HPV-16/18. INOVIO is also evaluating

INO-4800, a vaccine candidate against COVID-19, in a Phase 2/3 clinical trial;

the Phase 3 segment of which has received regulatory authorizations to proceed

in Colombia, Mexico, Brazil, Philippines, India, Thailand, and the United

States. INOVIO's partners, Advaccine Biopharmaceuticals and International

Vaccine Institute, are also evaluating INO-4800 in ongoing clinical trials in

China and South Korea, respectively.

Partners and collaborators include Advaccine, ApolloBio Corporation,

AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for Epidemic

Preparedness Innovations, Defense Advanced Research Projects Agency/Joint

Program Executive Office for Chemical, Biological, Radiological and Nuclear

Defense/Department of Defense, HIV Vaccines Trial Network, International

Vaccine Institute, Kaneka Eurogentec, Medical CBRN Defense Consortium, 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. 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 pre-clinical studies and clinical trials and

the availability and timing of data from those studies and trials, our ability

to successfully manufacture and produce large quantities of our product

candidates if they receive regulatory approval and planned collaborations with

third parties. 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 , our Quarterly Report

on Form 10-Q for the quarter ended June 30, 2021 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 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.