-- Up to 40 Healthy Volunteers To Participate at Two Trial Locations
-- Preclinical Animal Studies Show Promising Immune Responses 
-- Rapid Advancement Possible Through a Global Coalition of Collaborators, 
Partners, and Funders

INOVIO Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the U.S. Food 
and Drug Administration has accepted the company's Investigational New Drug 
(IND) application for INO-4800, its DNA vaccine candidate designed to prevent 
COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in 
healthy volunteers beginning this week. The first dosing is planned for today.

Dr. J. Joseph Kim, INOVIO's President and CEO, said, "This is a significant 
step forward in the global fight against COVID-19. Without a new safe and 
effective vaccine, the COVID-19 pandemic is likely to continue to threaten 
lives and livelihoods. It also demonstrates the power of our DNA medicines 
platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 
clinical testing. Our dedicated team of staff, partners and funders have been 
mobilized since the genetic sequence of the virus became available in early 
January and continues to work around the clock to ensure that we are rapidly 
advancing INO-4800 through this Phase 1 study towards planned efficacy trials."

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations 
(CEPI), said, "This development is an important step forward in the world's 
search for a COVID-19 vaccine. INOVIO's DNA vaccine platform was one of the 
first technologies selected by CEPI to develop a vaccine candidate against 
COVID-19. We are pleased to see the rapid advancement of their vaccine 
candidate into clinical safety testing. Producing a COVID-19 vaccine within the 
next 12 to 18 months is not only a scientific challenge; it will also require 
new levels of collaboration and investment across industry and government. 
There is still a long road ahead before we have a safe, effective, and globally 
accessible vaccine ready for broader use, but today we have reached an 
important milestone on that journey."

The Phase 1 study of INO-4800 will enroll up to 40 healthy adult volunteers in 
Philadelphia, PA (at the Perelman School of Medicine at the University of 
Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), 
where screening of potential participants has already begun. Study supplies of 
INO-4800 arrived at the sites last week. Each participant will receive two 
doses of INO-4800 four weeks apart, and the initial immune responses and safety 
data from the study are expected by late summer. Preclinical data, which have 
been shared with global regulatory authorities and submitted as part of the 
IND, have shown promising immune response results across multiple animal 
models. Additional preclinical trials, including challenge studies, will 
continue in parallel with the Phase 1 clinical trial.

Dr. Ami Shah Brown, INOVIO's Senior Vice President of Regulatory Affairs said, 
"Development and manufacture of a new vaccine with preclinical data to support 
a first-in-human trial in ten weeks from funding is a major milestone for 
INOVIO and our collaborators."

To date, preclinical results for INOVIO's COVID vaccine have been consistent 
with our completed Phase 1 vaccine study for Middle East Respiratory Syndrome 
(MERS), also caused by a coronavirus, in which INOVIO's DNA vaccine was well 
tolerated and induced high levels of antibody responses in 95% of subjects, 
while also generating broad-based T cell responses in nearly 90% of study 
participants. Durable antibody responses to its DNA vaccine (INO-4700) used in 
that trial were maintained through 60 weeks following dosing.

Upon attaining initial safety and immunogenicity data from Phase 1 studies, 
INOVIO plans to advance INO-4800 to Phase 2 efficacy studies as rapidly as 
possible. In 10 weeks from funding, INOVIO has manufactured thousands of doses 
of INO-4800 to support on-going Phase 1 and planned Phase 2 clinical trials. In 
parallel, INOVIO is working to scale up the manufacturing of INO-4800. INOVIO 
plans to have one million doses of the vaccine available by year-end for 
additional trials and emergency use, pending appropriate regulatory guidance 
and funding.

"We anticipate rapid enrollment of this initial study," said Pablo Tebas, MD, 
infectious disease specialist and professor of Medicine at the Hospital of the 
University of Pennsylvania and Principal Investigator of the study. "There has 
been tremendous interest in this vaccine among people who want to do what they 
can to help protect the greater public from this pandemic as soon as possible."

"INOVIO's leadership and the team's experience combined with the consistency of 
this DNA technology for clinical translation continue to be a major asset for 
the program," said Dr. David B. Weiner, Director of the Wistar Institute's 
Vaccine and Immunotherapy Center and Executive Vice President of the Institute.

INOVIO has assembled a global coalition of collaborators, partners, and funders 
to rapidly advance INO-4800. The scientific team at the Wistar Institute has 
provided key research contributions. The INOVIO program has been supported by 
generous funding from the Coalition for Epidemic Preparedness Innovations 
(CEPI) and the Bill and Melinda Gates Foundation. VGXI, Inc., a wholly-owned 
subsidiary of GeneOne Life Science (KSE: 011000) and INOVIO's manufacturing 
partner for the last 13 years, enabled the expedited manufacture, testing, and 
release of the INO-4800 plasmid clinical product. The U.S. Department of 
Defense (DOD) has also funded INOVIO's collaborator Ology Bioservices to 
manufacture additional doses of INO-4800.

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). 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(R) uses a brief electrical pulse to open 
small pores in the cell reversibly to allow the plasmids to enter, overcoming a 
key limitation of other DNA and mRNA approaches. Once inside the cell, the 
plasmids are used by the cell's own machinery to generate specific coded 
antigens, which then stimulate an immune response. 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 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 constructed 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 6,000 applications across a range of clinical trials, INOVIO has a 
strong track record of rapidly generating DNA medicine candidates 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, 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 
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, 90% 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)/DOD, GeneOne Life Science/VGXI, HIV 
Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC), National Cancer 
Institute, National Institutes of Health, National Institute of Allergy and 
Infectious Diseases, Ology Bioservices, 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.

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 medicine candidates, including 
INO-4800, 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 manufacturing and 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 manufacturing 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, 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.



SOURCE: INOVIO Pharmaceuticals, Inc.