Country for PR: United States
Contributor: PR Newswire New York
Thursday, April 30 2020 - 22:00
INOVIO Expands Manufacturing of COVID-19 DNA Vaccine INO-4800 With New Funding from CEPI
PLYMOUTH MEETING, Pennsylvania, April 30, 2020 /PRNewswire-AsiaNet/ --

-- 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 

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 

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 

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.


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 

Media: Jeff Richardson,+1 267-440-4211,
Investors: Ben Matone, +1 484-362-0076,

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.