Inovio MERS Vaccine Development to be Expanded with Funding from International Vaccine Institute
December 06 2016 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the
International Vaccine Institute (IVI) will provide new funding and
support to further advance GLS-5300, Inovio’s vaccine to prevent
Middle East Respiratory Syndrome (MERS) virus infection. Inovio is
co-developing this vaccine with GeneOne Life Science. IVI will add
technical, laboratory and financial support for GLS-5300 clinical
trials in Korea.
Inovio, GeneOne and its academic collaborators
have evaluated GLS-5300 in mice, rhesus macaques and camels. As
published in Science Translational Medicine, the vaccine induced
robust immune responses in all three species. GLS-5300 has been
specifically able to induce 100% protection from a live virus
challenge in a rhesus macaque non-human primate study. The results
of the non-human primate study supported the conduct of the first
phase I clinical trial of 75 healthy volunteers in collaboration
with the Walter Reed Army Institute of Research.
Dr. J. Joseph Kim, Inovio’s President & CEO
and a member of the Board of Trustees of IVI, said, “This
collaborative funding is part of a 41 billion Won (USD $34 million)
grant publicly pledged in 2015 from the Samsung Foundation to IVI
to support the development of a MERS vaccine for emergency use in
Korea and internationally. The goal of this funding is to expand
clinical testing of GLS-5300 toward emergency use authorization by
the Korean government as well as authorities of other
countries.”
“Inovio’s GLS-5300 remains the only vaccine for
MERS in clinical testing. With this support from IVI, Inovio,
GeneOne, and our other collaborators can expand GLS-5300 vaccine
development in Korea and the US. Our phase I MERS trial in the U.S.
is fully enrolled with 75 subjects dosed. We intend to report
interim data in early 2017 and publish the full data set in peer
reviewed journals. We already published positive non-human primate
protection results. After obtaining human safety and immunogenicity
data, we may be in position to secure additional external funding
as well as approach regulators next year to discuss the path to
approval via the “Animal Rule,” Dr. Kim said.
Despite the continuing threat of MERS outbreaks,
there are no licensed vaccines or treatments for MERS. Since the
virus was first identified in Saudi Arabia in 2012, the World
Health Organization reports almost 1,900 MERS infections and nearly
700 deaths worldwide. Twenty seven countries have reported cases,
including Korea where an outbreak in the summer of 2015 resulted in
186 cases and 38 deaths. While a SARS epidemic in 2003 killed 10%
of those infected, MERS has killed about 36% of people who
contracted this communicable virus.
About IVI
The International Vaccine Institute (IVI) is the
world’s only international organization devoted exclusively to
developing and introducing new and improved vaccines to protect the
world’s poorest people, especially children in developing
countries. Established in 1997, IVI operates as an independent
international organization under a treaty signed by 35 countries
and the World Health Organization. The Institute conducts research
in more than 20 countries of Asia, Africa and Latin America on
vaccines against enteric and diarrheal infections, Japanese
encephalitis, MERS, and dengue fever, and develops new and improved
vaccines at its headquarters in Seoul, Republic of Korea. For more
information, please visit http://www.ivi.int.
About GeneOne Life Science,
Inc.
GeneOne is an international company focused on
finding gene-based solutions to clinical disease. GeneOne is at the
forefront of DNA vaccine and DNA-based therapeutic development.
GeneOne is currently spearheading clinical trials of vaccines for
the Zika virus, MERS-CoV, Ebola and other infectious diseases.
GeneOne has a rich pipeline of products targeting multiple cancers
and diseases of man. GeneOne’s wholly-owned subsidiary VGXI, Inc.
(www.vgxii.com) has 15 years of experience in the manufacture of
DNA plasmid vaccines and therapeutics and has the distinction of
making vaccines for Zika, MERS, and Ebola for use in human clinical
trials. GeneOne is headquartered in Seoul, South Korea. For more
information, visit www.genels.com.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval University. For more
information, visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs and our capital resources. 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 and product
development programs, including the MERS vaccine GLS-5300, 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 broad 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
the company or its collaborators, including alternatives that may
be more efficacious or cost effective than any therapy or treatment
that the company and its collaborators hope to develop, issues
involving product liability, issues involving patents and whether
they or licenses to them will provide the company 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 the company can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
the company's 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, 2015,
our Form 10-Q for the quarter ended September 30,
2016, and other regulatory filings from time to time. There
can be no assurance that any product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the
forward-looking information provided herein will be proven
accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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