SEOUL, South Korea and
PLYMOUTH MEETING, Pa.,
June 4, 2020 /PRNewswire/
-- INOVIO (NASDAQ: INO), the International Vaccine Institute
(IVI), and Seoul National University
Hospital announced a partnership to start a Phase 1/2 clinical
trial of INOVIO's COVID-19 vaccine INO-4800 in South Korea at a signing ceremony today. In
attendance at the ceremony at SNU Hospital were IVI's Director
General Dr. Jerome Kim and Deputy
Director General of Science Dr. Manki
Song, Dr. Anh Wartel
(Associate Director General of EPIC and Head of Clinical
Development and Regulatory) and Dr. Daniel
Chul Woo Rhee (Project Lead), and SNU Hospital's President
Yon Su Kim and Prof. Myung Don Oh.
The 2-stage trial of INO-4800, the first clinical study of
COVID-19 vaccine in Korea, will assess the safety, tolerability,
and immunogenicity of the candidate vaccine in 40 healthy adults
aged 19-50 years, and will further expand to enroll an additional
120 people aged 19-64 years.
The trial, which aims to start later in June, is funded by the
Coalition for Epidemic Preparedness Innovations (CEPI) through
INOVIO and is supported by the Korea Center for Disease Control and
Prevention/Korea National Institute of Health. In normal
circumstances, it would generally take several years to start
clinical trials of a new vaccine. In the midst of the COVID-19
pandemic, however, the trial in Korea will be conducted just two
months after a similar clinical study began in the United States in early April 2020.
"We are thrilled to start the clinical trials of a COVID-19
vaccine candidate in collaboration with SNU Hospitals and with
support from KCDC/KNIH," said Dr. Jerome
Kim, Director General of IVI. "The trial is a crucial step
in the development of an urgently needed COVID-19 vaccine.
South Korea is one of the first
countries in the world set to test a COVID-19 vaccine (after the
U.S. China, UK, and Germany), and we are happy to collaborate with
South Korean partners to accelerate clinical development of a
COVID-19 vaccine through our partnership with INOVIO and CEPI."
Prof. Myung Don Oh of SNU
Hospital, who will lead the clinical trial, said "Social distancing
is making life challenging in all different aspects of our society
including business, education, culture, sports, and international
exchange, and we have reached a point where we cannot utilize
social distancing further," adding "We have to return to normalcy
and today's launch of the vaccine clinical trial will provide
significant momentum in easing fears over the pandemic and helping
return to normalcy."
Dr. J. Joseph Kim, INOVIO's
President & CEO, said, "As part of INOVIO's global coalition of
COVID-19 vaccine collaborators, funders and manufacturers we look
forward with enthusiasm to advance our DNA vaccine in partnership
with the International Vaccine Institute (IVI) and Seoul
National University Hospital to rapidly
begin clinical trials in Korea, We will soon have Phase 1 data from
a US trial of INO-4800 and plan to begin Phase 2/3 trials in
mid-summer. We thank IVI and SNU Hospital for their work to speed
the Korea trial of INO-4800."
The speedy regulatory approval was made possible with support
from the Korean Ministry of Food and Drug Safety following its
adoption in April of a fast-track approval process for clinical
trials of COVID-19 vaccines and therapeutics that are developed
with a proven safety platform. Such vaccines, including DNA
vaccines, can be exempt from toxicology tests leveraging the
available preclinical data using the DNA platform, and expediting
clinical trial review process. The DNA vaccine of US-based INOVIO
to be tested was one of the first technologies to receive support
from CEPI, greatly accelerating the development process of the
COVID-19 vaccine.
IVI and SNU Hospitals have collaborated in the past to conduct
Phase 1/2a trials for a MERS coronavirus vaccine. The MERS vaccine
(INO-4700/GLS-5300) developed by INOVIO and South Korea's GeneOne Life Science and, in
trials conducted so far, has achieved promising results.
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 CEPI
CEPI is an innovative partnership between public, private,
philanthropic, and civil organisations, 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 9 partnerships to develop vaccines against the
novel coronavirus. The programmes 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). Follow our news page for the latest
updates.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to protect and treat 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)/Department of Defense (DOD), GeneOne Life
Science/VGXI, HIV Vaccines Trial Network, International Vaccine
Institute (IVI), 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, 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.
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
DNA medicines, our expectations regarding our research and
development programs, including the planned initiation and conduct
of preclinical studies and clinical trials, and the availability
and timing of data from those studies and trials. Actual events or
results may differ from the expectations set forth herein as a
result of a number of factors, including uncertainties inherent in
pre-clinical 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 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 March 31, 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.
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SOURCE INOVIO Pharmaceuticals, Inc.