AsiaNet 84600

PLYMOUTH MEETING, Pennsylvania, June 30, 2020 /PRNewswire=KYODO JBN/--

-- INO-4800 Selected for the U.S. Government's Operation Warp Speed

-- 94% of Phase 1 trial participants demonstrated overall immune responses at

Week 6 after two doses of INO-4800 in trial with 40 healthy volunteers in

preliminary analyses

-- Through Week 8 INO-4800 regimen was deemed safe and well-tolerated with no

serious adverse events; all reported adverse events were grade 1 in severity

-- In preclinical animal challenge study, INO-4800 provided full protection

against SARS-CoV-2 replication in the lungs in mice challenged with the virus

-- INOVIO to begin U.S. Phase 2/3 efficacy study this summer upon regulatory

concurrence

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

market precisely designed DNA medicines to protect and treat people from

infectious diseases and cancer, today announced positive interim clinical data

of INO-4800, its vaccine candidate against novel coronavirus (SARS-CoV-2), from

the first two Phase 1 clinical trial cohorts. In addition, INO-4800 has been

selected to participate in a non-human primate (NHP) challenge study as part of

the U.S. government's Operation Warp Speed, a new national program aiming to

provide substantial quantities of safe, effective vaccine for Americans by

January 2021. Furthermore, INOVIO has expanded its Phase 1 trial to add older

participants in additional cohorts and plans to initiate a Phase 2/3 efficacy

trial this summer upon regulatory concurrence.

Dr. J. Joseph Kim, President and CEO of INOVIO, said, "INOVIO would like to

thank all of the trial participants and the investigator staff who have made

this trial possible. We are very encouraged by the positive interim safety and

preliminary cellular and humoral immune response results to date as well as the

inclusion of INO-4800 in Operation Warp Speed. We are also pleased that

INO-4800 vaccination abrogated viral replication in the lungs of mice

challenged with SARS-CoV-2. We look forward to urgently advancing INO-4800, as

it 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 for

years of storage, which are important factors when implementing mass

immunizations to battle the current pandemic."

The Phase 1 clinical trial of INO-4800 initially enrolled 40 healthy adult

volunteers 18 to 50 years of age at two U.S. sites with funding from the

Coalition for Epidemic Preparedness Innovations (CEPI). The participants were

enrolled into 1.0 mg and 2.0 mg dose cohorts; each participant received two

doses of INO-4800 four weeks apart. Each dose was administered by intradermal

injection using INOVIO's CELLECTRA(R) 2000 device. An independent Data Safety

Monitoring Board reviewed the safety data. INO-4800 was generally safe and

well-tolerated in all participants in both cohorts through week 8; all ten

reported adverse events (AEs) were grade 1 in severity, and most were local

injection site redness. There were no reported serious adverse events (SAEs).

Multiple immunology assays including those for humoral and cellular immune

responses are being conducted for both 1.0 mg and 2.0 mg dose cohorts after two

doses at week 6. Analyses to date have shown that 94% (34 out of 36 total trial

participants) demonstrated overall immunological response rates based on

preliminary data assessing humoral (binding and neutralizing) and T cell immune

responses. One participant in the 1.0 mg dose cohort and two participants in

the 2.0 mg dose cohort were excluded in the immune analyses as they tested

positive for COVID-19 immune responses at study entry, indicating prior

infection. One participant in the 2.0 mg dose cohort discontinued the study for

reasons unrelated to safety or tolerability. INOVIO plans to publish the full

data set in a peer-reviewed medical journal.

One key feature of INOVIO's DNA vaccines is the ability to generate balanced

antibody and T cell immune responses, which in the case of SARS-CoV-2 infection

could be important in the development of potential COVID-19 vaccines. In this

regard, recent scientific reports have highlighted that SARS-CoV-2-specific T

cells found in convalescent patients have been positively implicated in

controlling the severity of their COVID-19 disease (Grifoni et al, Cell 2020)

while other studies have shown that a significant proportion (33% to 40%) of

convalescent individuals in their reports had neutralizing antibody below

detectable levels (Robbiani et al, Nature 2020 and Payne et al, MMWR 2020).

In addition to positive interim Phase 1 data, INO-4800 has been shown to

protect mice in SARS-CoV-2 viral challenge studies, where vaccination with

INO-4800 prevented viral replication in the lungs of animals challenged with

SARS-CoV-2. Moreover, INO-4800 is currently being tested in a ferret challenge

model as well as in NHP challenge studies as part of Operation Warp Speed.

"While the pathophysiologic profile of SARS-CoV-2 is not completely understood,

research and clinical studies suggest that both T cell and antibody immune

responses will be important for protection in both mild and serious infections.

Leveraging our previous expertise in MERS with INO-4700, where we demonstrated

significant antibody and cellular responses, the breadth and profile of the

responses observed to date with INO-4800 targeting SARS-CoV-2 provide a

promising read towards further development and addressing the existing public

health threat," said Dr. Kate Broderick, Senior Vice President of R&D at INOVIO.

As previously announced, INOVIO received $71 million funding from the U.S.

Department of Defense to support the large-scale manufacture of the company's

proprietary CELLECTRA® 3PSP smart device and the procurement of CELLECTRA® 2000

devices. INO-4800 development has also been supported by generous funding from

CEPI and the Bill & Melinda Gates Foundation.

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

rapidly using INOVIO's proprietary DNA medicine platform 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

Phase 2 vaccine 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)/Joint Program Executive Office for

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

          +1-267-440-4211

          jrichardson@inovio.com

          Investors:

          Ben Matone

          +1-484-362-0076

          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.