Country for PR: United States
Contributor: PR Newswire New York
Thursday, April 16 2020 - 20:00
AsiaNet
IVI, INOVIO, and KNIH to Partner with CEPI in Phase 1/2 Clinical Trial of INOVIO's COVID-19 DNA Vaccine in South Korea
PLYMOUTH MEETING, Pa. and SEOUL, South Korea, April 16, 2020 /PRNewswire-AsiaNet/ --

-- 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.
Translations

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