IVI, INOVIO, and KNIH to Partner with CEPI in Phase 1/2 Clinical Trial of INOVIO's COVID-19 DNA Vaccine in South Korea

INOVIO Pharmaceuticals, Inc.

PR83692

 

PLYMOUTH MEETING, Pa. and SEOUL, South Korea, April 16, 2020 /PRNewswire=KYODO JBN/ --

 

-- The Coalition for Epidemic Preparedness Innovations (CEPI) grants $6.9

million funding to INOVIO and IVI to conduct clinical testing in Korea for

INOVIO's COVID-19 vaccine candidate based on their well-established DNA

platform technology

 

-- Korea National Institute of Health (KNIH) to support IVI's testing efforts

 

The International Vaccine Institute (IVI) announced today that the Coalition

for Epidemic Preparedness Innovations (CEPI) has granted $6.9 million funding

to INOVIO (NASDAQ:INO) to work with IVI and the Korea National Institute of

Health (KNIH) for a Phase 1/2 clinical trial of INOVIO's COVID-19 vaccine

candidate (INO-4800) in South Korea. IVI will conduct the trial in parallel to

INOVIO's Phase 1 INO-4800 study currently underway in the US since April 6,

2020 with 40 healthy adults receiving the vaccine candidate and eventually

expanding to older adults.

 

Dr. Jerome H. Kim, Director General of IVI, said, "Vaccines are the long-term

solution to controlling the COVID-19 pandemic. The rapid global response to

developing vaccine candidates has been a profound demonstration of governments,

industry, and the scientific community coming together to confront a common

crisis, and we're looking forward to accelerating one of those candidates

through clinical testing. IVI has achieved promising trial results with

INOVIO's DNA vaccine platform in the past, and we're pleased to partner again

to test the safety and immunogenicity of an urgently needed COVID-19 vaccine."

 

Dr. J. Joseph Kim, INOVIO's President and CEO, said, "Developing a safe and

effective COVID-19 vaccine is a global imperative, and we're pleased to partner

with IVI and KNIH to test INO-4800 in South Korea. Our DNA vaccine platform was

one of the first technologies to receive support from CEPI to accelerate a

COVID-19 vaccine, and IVI conducting safety and efficacy trials in South Korea

is a crucial step forward in evaluating this vaccine."

 

Dr. Richard Hatchett, CEO of CEPI said, "Developing a safe and effective

vaccine and ensuring its global supply is our best exit strategy from the

COVID-19 pandemic. CEPI is pleased to work with INOVIO and IVI in this critical

next stage of testing."

 

INOVIO's DNA vaccine platform is also utilized in their MERS vaccine, INO-4700,

for which IVI previously conducted Phase I clinical testing with GeneOne Life

Science in South Korea.

 

This news follows the announcement from the Korean Ministry of Food and Drug

Safety made on April 13th that they will adopt a fast-track approval process

for COVID-19 vaccine and treatment clinical trials. The period of clinical

trial screening will be shortened to seven days (down from 30 days) for

substances with experience in use and within 15 days for new materials.

Additionally, vaccines developed with a proven safety platform, such as

INOVIO's DNA platform, will be exempt from toxicology tests which will minimize

data submission and expedite clinical trials. Plumbline Life Sciences (XKRX:

222670) of South Korea also collaborated on this project. Korea Centers for

Disease Control and Prevention (KCDC) and the KNIH and has also pledged their

support for IVI's testing efforts.

 

About 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, the University of Texas, Twist

Biosciences, and the Lavalle University. 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

Organisation (CSIRO) in Australia. INOVIO is also working with a team of

contract manufacturers including VGXI, Inc., Richter-Helm, and Ology

Biosciences to produce up to one million doses of INO-4800 by year end and

seeking additional external funding and partnerships to scale up the

manufacturing capacities to satisfy urgent global demand for safe and effective

vaccine. To date, the Coalition for Epidemic Preparedness Innovations (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 the International Vaccine Institute (IVI)

 

The International Vaccine Institute (IVI) is a nonprofit inter-governmental

organization established in 1997 at the initiative of the United Nations

Development Programme (UNDP).

 

Headquartered in Seoul, South Korea, IVI was the first international

organization hosted by Korea. IVI has 35 signatory countries and the World

Health Organization (WHO) on its treaty, including Republic of Korea, Sweden

and India as state funders.

 

Our mandate is to make vaccines available and accessible for the world's most

vulnerable people. We focus on infectious diseases of global health importance

such as cholera, typhoid, shigella, salmonella, schistosomiasis, Group A

Streptococcus, Hepatitis A, HPV, TB, HIV, MERS, COVID-19, as well as

antimicrobial resistance. For more information, please visit

https://www.ivi.int.

 

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.

 

About CEPI

 

CEPI is an innovative partnership between public, private, philanthropic, and

civil society organizations, launched at Davos in 2017, to develop vaccines to

stop future epidemics. CEPI has moved with great urgency and in coordination

with WHO in response to the emergence of COVID-19. CEPI has initiated 8

partnerships to develop vaccines against the novel coronavirus. The programs

will leverage rapid response platforms already supported by CEPI as well as new

partnerships. The aim is to advance COVID-19 vaccine candidates into clinical

testing as quickly as possible.

 

Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus,

Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift

Valley Fever and Chikungunya virus. CEPI also invested in platform technologies

that can be used for rapid vaccine and immunoprophylactic development against

unknown pathogens (Disease X).

 

CONTACTS

 

IVI Media:

 

Youngmi Cho, Head of Global Affairs & Communications, +82-2-881-1439,

youngmi.cho@ivi.int

 

Aerie Em, Global Communications & Media Specialist, +82-2-881-1386,

aerie.em@ivi.int

 

CEPI:

 

Rachel Grant, Director of Communications and Advocacy, Rachel.Grant@cepi.net

 

INOVIO Media:

 

Jeff Richardson, VP Strategic Relations, +1-267-440-4211, jrichardson@inovio.com

 

INOVIO Investors:

 

Ben Matone, Senior Director, IR, +1-484-362-0076, ben.matone@inovio.com

 

This press release contains certain forward-looking statements relating to

INOVIO's business, including our plans to develop DNA medicines, 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

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 preclinical 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 vaccines, our ability to support our pipeline

of SynCon(R) active immunotherapy and vaccine 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.

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