Country for PR: United States
Contributor: PR Newswire New York
Friday, December 04 2020 - 00:00
INOVIO Expands Global Manufacturing Consortium For Its COVID-19 Vaccine Candidate INO-4800 With Addition of Kaneka Eurogentec S.A.
PLYMOUTH MEETING, Pa., Dec. 3, 2020 /PRNewswire-AsiaNet/ --

  -- Partnership with leading global plasmid manufacturer advances 
     INOVIO's INO-4800

  -- Kaneka Eurogentec to support production of INO-4800 

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market 
precisely designed DNA medicines to treat and protect people from infectious 
diseases and cancer, today announced the execution of an agreement with Kaneka 
Eurogentec S.A., an affiliate of Kaneka Corporation, for Eurogentec to 
manufacture INOVIO's COVID-19 vaccine candidate INO-4800 at their 
industry-leading GMP plasmid production scales. Terms of the agreement were not 

Kaneka Eurogentec joins existing partners Thermo Fisher Scientific, 
Richter-Helm BioLogics and Ology Biosciences in INOVIO's global manufacturing 
consortium. Each contract development and manufacturing organization that has 
been selected to join the consortium is compliant with commercial GMP standards 
and capable of supporting INOVIO's future large-scale global manufacturing 
needs across its portfolio of DNA medicines and vaccines.

INOVIO's President & CEO, Dr. J. Joseph Kim, said, "Our partnership with Kaneka 
Eurogentec, one of the world's largest and most experienced plasmid 
manufacturers, provides additional scale to our growing global manufacturing 
coalition. Kaneka Eurogentec will be a crucial member of INOVIO's global 
manufacturing consortium, supporting our plans to produce, manufacture and 
scale our COVID-19 vaccine candidate, INO-4800."

Dr. Lieven Janssens, Kaneka Eurogentec's President and CEO, said, "We are 
excited to join INOVIO's growing global manufacturing consortium and look 
forward to supporting the manufacturing needs of DNA medicines and vaccines 
across INOVIO's platform. We are pleased that our large-scale manufacturing 
technologies are well-recognized by INOVIO, a leading player in the DNA plasmid 

INOVIO's Senior Vice President of Biological Manufacturing and Clinical Supply 
Management, Robert J. Juba Jr., said, "Kaneka Eurogentec brings a wealth of DNA 
plasmid manufacturing expertise and innovation to INOVIO's global consortium to 
manufacture INO-4800. We look forward to working with them to utilize their 
state-of-the-art, large-scale manufacturing capabilities towards our goal of 
producing hundreds of millions of doses of INO-4800 for worldwide distribution."

INOVIO recognizes the importance of having a robust coalition to support its 
broader development platform for DNA medicines as well as its COVID-19 vaccine 
candidate, INO-4800. As a result, the company continues to build the coalition 
to ensure timely, cost-effective and scalable production of DNA medicines and 
vaccines. INOVIO's third-party manufacturers will produce the patent-protected 
formulation for INO-4800, developed to enhance stability of the vaccine with a 
favorable tolerability profile. Importantly, INO-4800 has shown an excellent 
thermo-stability profile. INOVIO's other platform DNA vaccine candidates have 
also demonstrated a shelf life of greater than 5 years when refrigerated and 
stability for more than 30 days at 37 degrees Celsius, and more than one year 
at room temperature. INOVIO's candidates also do not need to be frozen during 
transport or storage, a vital factor when implementing immunizations on a 
global scale. INO-4800 is administered via INOVIO's proprietary CELLECTRA(R) 
smart delivery device, which delivers the vaccine locally into the patient's 
skin, a process that takes only a few seconds. 

INOVIO is conducting a Phase 2 segment of its planned Phase 2/3 clinical trial 
for INO-4800, its COVID-19 vaccine candidate. The planned Phase 2/3 clinical 
trial, called INNOVATE (INovio INO-4800 Vaccine Trial for Efficacy), is a 
randomized, blinded, placebo-controlled safety and efficacy trial of INO-4800 
to be conducted in adults in the U.S. The INNOVATE trial will be funded by the 
U.S. Department of Defense (DoD) Joint Program Executive Office for Chemical, 
Biological, Radiological and Nuclear Defense (JPEO-CBRND) in coordination with 
the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) 
and the Defense Health Agency (DHA).

The DoD has agreed to provide funding for both the Phase 2 and Phase 3 segments 
of the INNOVATE clinical trial, in addition to the $71 million of funding 
previously announced in June for the large-scale manufacture of the company's 
proprietary smart device CELLECTRA(R) 3PSP and the procurement of CELLECTRA(R) 
2000 devices. 

About the INO-4800 "INNOVATE" Phase 2/3 Clinical Trial 

The lead Principal Investigator for the INNOVATE trial is Dr. Pablo Tebas, 
Professor of Medicine at the Hospital of the University of Pennsylvania. The 
Phase 2 segment of the trial is designed to evaluate safety, tolerability and 
immunogenicity of INO-4800 in a 2-dose regimen (1.0 mg or 2.0 mg), in a 
three-to-one randomization to receive either INO-4800 or placebo for each dose, 
to confirm the more appropriate dose(s) for each of three age groups (18-50 
years, 51-64 years and 65 years and older) for the subsequent Phase 3 efficacy 
evaluation. The company intends to work diligently to ensure diversity in 
enrollment, targeting specific populations that are working or residing in 
environments with high infection rates and/or areas where there is greater risk 
of exposure to SARS-CoV-2, for whom exposure may be relatively prolonged or for 
whom personal protective equipment (PPE) may be inconsistently used, especially 
in confined settings.

In the Phase 3 segment of the trial, INOVIO intends to enroll healthy men and 
non-pregnant women 18 years and older, to evaluate the efficacy of the proposed 
dose(s) based on the data from the Phase 2 evaluation. Participants will be 
enrolled in a one-to-one randomization to receive either INO-4800 or a placebo. 
The Phase 3 segment will be case-driven with the final number of enrollees to 
be determined by the incidence of COVID-19 during the Phase 3 segment. The 
primary endpoint of the Phase 3 segment will be virologically-confirmed 
COVID-19 disease.

About INOVIO's Global Coalition Advancing INO-4800

INOVIO has assembled a global coalition of collaborators, partners and funders 
to rapidly advance the development of INO-4800. R&D collaborators to date 
include the Wistar Institute, the University of Pennsylvania, the University of 
Texas, Fudan University and Laval University. INOVIO has partnered with 
Advaccine and the International Vaccine Institute to conduct clinical trials of 
INO-4800 in China and South Korea, respectively. INOVIO is also assessing 
nonclinical 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 working with a team of contract 
manufacturers including Kaneka Eurogentec, Thermo Fisher Scientific, 
Richter-Helm BioLogics, and Ology Bioservices to manufacture INO-4800 on a 
commercial scale and is seeking additional external funding and partnerships to 
further scale up manufacturing capacities to satisfy the urgent global demand 
for safe and effective vaccines. To date, the Coalition for Epidemic 
Preparedness Innovations (CEPI), the Bill & Melinda Gates Foundation, and the 
U.S. 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 intended to protect against 
SARS-CoV-2, the novel coronavirus that causes COVID-19. INOVIO has extensive 
experience working with coronaviruses and was the first company to initiate a 
Phase 2a trial for INO-4700, a vaccine for Middle East Respiratory Syndrome 
(MERS), another coronavirus related to SARS-CoV-2.

INO-4800 is the only nucleic-acid based vaccine that is stable at room 
temperature for more than a year and does not need to be frozen in transport of 
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 
U.S. Department of Defense. 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 observed 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 Kaneka Eurogentec

Eurogentec was founded in 1985 as a spin-off of the University of Liège 
(Belgium). Kaneka Eurogentec contributes to improving health and fighting 
diseases by supplying products and services to scientists involved in life 
science research, molecular diagnostics, and therapeutic developments. The 
Liège-based company is recognized as one of the major suppliers in the field of 
genomics and proteomics as well as a trusted US FDA inspected Contract 
Development and Manufacturing Organization (CDMO) for the bio-production of 
pharmaceuticals vaccines and medicines. Kaneka Eurogentec is a leading company 
in large scale production of GMP DNA Plasmid for DNA vaccines and starting 
materials for vector-based gene medicines. In parallel, Kaneka Eurogentec 
offers CDMO services for GMP mRNA, the active molecule of RNA vaccines and RNA 
based gene therapy. In 2010, Eurogentec, renamed Kaneka Eurogentec in April 
2017, became part of Kaneka Corporation, a large Japanese chemical company 
focusing on technology and innovation. For more information, visit 


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), HIV Vaccines Trial Network, International Vaccine Institute 
(IVI), Kaneka Eurogentec, 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, 
Thermo Fisher Scientific, 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, 267-440-4211, 
Investors: Ben Matone, 484-362-0076,

This press release contains certain forward-looking statements relating to our 
business, including our plans to develop and manufacture DNA medicines, our 
expectations regarding our research and development programs, including the 
planned initiation and conduct of the Phase 2/3 clinical trial of INO-4800, and 
our ability to successfully manufacture and produce large quantities of our 
product candidates if they receive regulatory approval. Actual events or 
results may differ from the expectations set forth herein as a result of a 
number of factors, including uncertainties inherent in preclinical 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 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 September 30, 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.