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