PLYMOUTH MEETING, Pa. and
SEOUL, South Korea, April 16, 2020 /PRNewswire/ -- 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® 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.
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SOURCE INOVIO Pharmaceuticals, Inc.