PR87030

PLYMOUTH MEETING, Pa., Dec. 3, 2020 /PRNewswire=KYODO JBN/ --

  -- 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 disclosed.

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 field."

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

https://www.eurogentec.com/

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), 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

www.inovio.com.

CONTACTS:

Media: Jeff Richardson, 267-440-4211, jrichardson@inovio.com

Investors: Ben Matone, 484-362-0076, ben.matone@inovio.com

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.