Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced its
DNA-based Zika vaccine (GLS-5700) generated robust antigen-specific
antibody responses in a first-in-man, multi-center phase I trial.
In initial testing, Zika-naïve subjects in both low dose and high
dose vaccine groups demonstrated Zika antigen-specific antibody
responses after one or two vaccinations. In addition, the vaccine
was well tolerated and no significant safety concerns were noted in
any of the 40 subjects out to 14 weeks from initiation of dosing,
the latest available data from the study.
This phase I, open-label, dose-ranging study of
GLS-5700 in healthy adult volunteers is evaluating the safety,
tolerability and induction and persistence of Zika specific
antibody and T cell responses out to 60 weeks. In preclinical
testing Inovio’s Zika vaccine protected animals that had been
exposed to the virus from infection, brain damage and death.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “These early clinical results show that Inovio is on track to
rapidly develop Zika countermeasures for this disease that has no
currently existing vaccine or treatment. Our synthetic vaccine
technology allows rapid development of new products, leading Inovio
to be the first to create a Zika vaccine, the first to generate
preclinical data, the first to initiate human testing, and now
first to report positive clinical data.”
“We also look forward to completing our second
phase I study of 160 subjects in Puerto Rico, where the CDC
estimates 25% of the population could be infected with Zika virus
by year end. We expect results next year which may provide
exploratory signals of vaccine efficacy. Based on these two
studies, we plan to meet with regulators to map out the most
efficient path forward to bring our Zika vaccine to patients and
help mitigate this widespread Zika outbreak that has expanded into
the continental United States.”
Inovio is developing its Zika vaccine, GLS-5700,
with GeneOne Life Science, Inc. (KSE:011000) and academic
collaborators from the U.S. and Canada who are also collaborating
to advance clinical development of Inovio’s Ebola and MERS
vaccines.
In addition to the vaccine development, earlier
this month, Inovio and The Wistar Institute received an $8.8
million grant from the Bill & Melinda Gates Foundation to
develop a DNA-based monoclonal antibody designed to provide
fast-acting protection against Zika infection and its debilitating
effects. Unlike vaccines, monoclonal antibody-based therapies could
provide more immediate protection but do not develop long-term
immune memory. An ideal approach would therefore include the
co-administration of a dMAb™ product for immediate protection and a
DNA vaccine to train the immune system for longer-term, persistent
protection against Zika infection.
About Zika Virus
First identified in Uganda, Zika virus
subsequently spread to equatorial Asia and over the past two years
has rapidly spread through the South Pacific, Hawaii, South
America, Central America, and the Caribbean. In 2016, active local
mosquito-borne transmission began to occur in North America,
specifically confirmed in Florida and reported but awaiting
confirmation in Texas. Zika virus is a flavivirus, a family of
viruses including yellow fever, dengue, and West Nile virus, which
are introduced to people through mosquito bites. Because the Aedes
species of mosquitoes that spreads Zika virus is found throughout
the world there is concern that Zika will continue to spread to new
countries and regions. As of December 2016, 68 countries and
territories (including 48 in the Americas) reported continuing
mosquito-borne transmission of the Zika virus, compared to 33
countries stated by WHO in their first Zika situation report in
February 2016. Unlike other flaviviruses, Zika virus can be
sexually transmitted.
The most common manifestations of symptomatic
Zika virus infection are fever, rash, joint pain, and
conjunctivitis. Zika is very strongly associated with and almost
certainly causes birth defects, most notably microcephaly, which
arises from infection during pregnancy. Microcephaly is the result
of incomplete brain development which is manifested as an
abnormally small head and severe mental retardation. In adults,
Zika virus infection is also associated with Guillain-Barre
syndrome, which causes muscle weakness of the limbs and in severe
cases may cause almost total paralysis including the inability to
breathe. Recent reports suggest Zika may also be associated with
other neurological abnormalities and abnormalities in other systems
including ocular and cardiac.
No vaccine or therapy currently exists for the
prevention or treatment of infection of the Zika virus.
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 Zika vaccine GLS-5700, 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
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Sep 2023 to Sep 2024