PR83872

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

-- INOVIO and Richter-Helm BioLogics will expand existing DNA manufacturing

agreement to support large-scale manufacturing of INO-4800

-- INO-4800 Phase 2/3 U.S. clinical trial being prepared to start this summer

INOVIO (NASDAQ:INO) today announced it has entered into an agreement to expand

its manufacturing partnership with the German contract manufacturer

Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of

INOVIO's investigational DNA vaccine INO-4800, which currently is in Phase 1

clinical testing in the U.S. for COVID-19 and could potentially advance to

Phase 2/3 efficacy trials this summer. The agreement is being partly funded by

an initial grant of $1.3 million from the Coalition for Epidemic Preparedness

Innovations (CEPI), which brings CEPI's total support to date for the

development of INO-4800 to $17.2 million.

"We are grateful to CEPI for its continued generous funding and pleased to

expand our work with Richter-Helm BioLogics to support large-scale

manufacturing capacity for INO-4800," said INOVIO's President & CEO, Dr. J.

Joseph Kim. "Richter-Helm has deep experience working with our optimized DNA

plasmids, which are the building blocks of our DNA vaccines, and have

consistently produced DNA medicines of the highest quality under stringent GMP

standards."

INOVIO has been working with Richter-Helm BioLogics, which manufactures

INOVIO's DNA medicine candidate VGX-3100, since 2014. Currently, VGX-3100 is in

Phase 3 clinical trials for the treatment of precancerous cervical dysplasia

caused by high-risk human papillomavirus (HPV). INOVIO has established

commercial-scale plasmid production at Richter-Helm BioLogics for its DNA

medicines platform, with successful technology transfer already demonstrated

for VGX-3100 and an Advanced Therapy Medicinal Product (ATMP) certification

granted by the European Medicines Agency (EMA) in May 2019.

"Richter-Helm BioLogics has a strong, long-standing relationship with INOVIO

and is a leading manufacturer of DNA plasmids," said Richter-Helm BioLogics'

Managing Director Dr. Kai Pohlmeyer. "We will mobilize all our resources to

ensure sufficient supply of late-stage clinical and commercial batches of

INO-4800 and contribute to the fight against the deadly COVID-19 pandemic."

INOVIO plans to produce one million doses of INO-4800 by the end of 2020.

Additional capacity provided by Richter-Helm will significantly expand

manufacturing of this DNA vaccine candidate to meet urgent needs in the midst

of the pandemic.

"Having a trusted and proven partner with extensive experience manufacturing

INOVIO's DNA medicines is critical as we scale up our INO-4800 production,"

said Robert Juba, INOVIO's vice president of Biological Manufacturing and

Clinical Supply Management. "We look forward to continue to work closely

together in our efforts to reduce the worldwide impact of COVID-19."

Richter-Helm Biologics is using manufacturing technology developed by VGXI

Inc., a wholly owned subsidiary of GeneOne Life Science (KSE:011000} and

INOVIO's contract manufacturer for early-stage clinical trial supply, under a

license agreement from VGXI. Richter-Helm BioLogics will transfer and rapidly

scale up the current (400 L scale) production process for the INO-4800 DNA

plasmid from VGXI. Richter-Helm BioLogics and VGXI already share a long-term

partnership that has resulted in numerous joint projects and project transfers

followed by plasmid DNA production for commercial supply at Richter-Helm

BioLogics´ facilities, including the technology transfer and Phase 3

manufacturing for VGX-3100.

About INOVIO's Global Coalition Advancing INO-4800

INOVIO has assembled a global coalition of collaborators, partners and funders

to rapidly advance INO-4800. R&D collaborators to date include the Wistar

Institute, the University of Pennsylvania, Université Laval, and the University

of Texas. INOVIO has partnered with Beijing Advaccine and the International

Vaccine Institute to advance clinical trials of INO-4800 in China and South

Korea, respectively. INOVIO is also assessing preclinical efficacy of INO-4800

in several animal challenge models with Public Health England (PHE) and

Commonwealth Scientific and Industrial Research Organization (CSIRO) in

Australia. INOVIO is also working with a team of contract manufacturers

including VGXI, Inc., Richter-Helm, and Ology Biosciences to produce one

million doses of INO-4800 by year-end and seeking additional external funding

and partnerships to scale up the manufacturing capacities to satisfy the urgent

global demand for a safe and effective vaccine. To date, CEPI, the Bill &

Melinda Gates Foundation, and the US Department of Defense have contributed

significant funding to the advancement and manufacturing of INO-4800.

About INO-4800

INO-4800 is INOVIO's DNA vaccine candidate created 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 deep

experience working with coronaviruses and is the only company with a Phase 2a

vaccine for a related coronavirus that causes Middle East Respiratory Syndrome

(MERS).

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). 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 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 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 potentially treat 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, 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, Plumbline Life Sciences, Regeneron, Richter-Helm,

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 planned

initiation and conduct of clinical trials, and the availability and timing of

data from those trials. 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, 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.