Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported today on
positive safety and immune response results from a first-in-man,
multi-center phase 1 trial of a vaccine against the Zika virus. The
phase 1 trial of Inovio’s DNA-based Zika vaccine (GLS-5700) induced
high levels of binding antibodies in 100% of participants. Robust
neutralizing antibody and T cell immune response were also observed
in vaccinated subjects. These positive results appear in the New
England Journal of Medicine in the article: “Safety and
Immunogenicity of an Anti-Zika Virus DNA Vaccine,” by Inovio
researchers and collaborators.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Inovio is the first organization in the world to report on
positive Zika vaccine data from a clinical study. We’ve posted
similar encouraging HIV, Ebola and MERS vaccine data arising from
our product development engine of DNA-immunotherapies and vaccines.
Results from this published study demonstrate that all human
subjects responded to the vaccine and that the immune responses
have the ability to confer protection in challenge models. A second
phase 1 study, now fully enrolled in Puerto Rico, is designed with
a placebo control to explore a potential trend towards clinical
efficacy. Inovio is proud to be a pioneer of Zika vaccine
development, and the first to generate positive human data that
clearly supports advancement of DNA technology and our vaccine
candidate.”
In this phase 1 study (ZIKA-001), a total of 40
participants (20 in each of two groups) received GLS-5700 in a 1 mg
or 2 mg dose. The vaccine was administered in 0.1 ml intradermal
injections administered by Inovio’s CELLECTRA® 3P skin vaccine
device. The GLS-5700 Zika vaccine induced binding antibodies in
100% of the participants after a three-dose vaccination regimen and
in 95% after two doses of vaccine. In addition, neutralizing
antibodies were observed in more than 95% of the serum samples that
were assayed on neuronal-cell targets. Serum samples from
vaccinated subjects when subsequently transferred to mice were
found to be protective from death and illness in more than 90% of
animals after they were challenged with a lethal dose of the Zika
virus.
Inovio’s second fully enrolled clinical study is
a placebo-controlled, double-blind trial involving 160 healthy
adult volunteers (80 subjects received vaccine and 80 subjects
received placebo) to evaluate the safety, tolerability and
immunogenicity of GLS-5700 in dengue virus-positive individuals.
Inovio will also assess differences in Zika infection rates in
participants given either placebo or vaccine as part of an
exploratory efficacy endpoint.
Preclinical data published in the peer-reviewed
journals npg Vaccines (2016) and Nature Communications (2017)
showed that Inovio’s Zika vaccine generated single-dose protection
in 100% of mice and non-human primates from death as well as
neurologic or testicular effects of the Zika virus.
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.
A recent CDC study found that upwards of 5% of
children born to pregnant women with Zika infection had
abnormalities and these were noted even with infections as late as
the third trimester. Babies born with congenital Zika syndrome
resulting from Zika infection of an expectant mother often have
severe microcephaly, a neurological condition in which babies are
born with abnormally small heads. Other abnormalities include
diminished brain tissue and eye damage, as well as restricted joint
movement and rigid muscle tone. Recent research suggests they may
also suffer hearing problems and seizure disorders such as
epilepsy.
There is no approved therapy or vaccine for Zika
infection, presenting a major unmet medical need given that the
World Health Organization estimates that more than two billion
people are directly at risk for infection. Importantly, infection
with the Zika virus during pregnancy can cause a pattern of birth
defects including microcephaly.
About Inovio’s DNA Immunotherapy
Technology Platform
Inovio is advancing the medical potential of a
unique class of immunotherapy technology. Its DNA-based platform,
which is the foundation of all Inovio products, including GLS-5700,
is unique in its ability to leverage the body’s naturally existing
mechanisms to generate robust, highly targeted immune responses to
prevent and treat disease – and to do so in the body with a
favorable safety profile. Its SynCon® immunotherapy design and
CELLECTRA® delivery system transform novel genetic blueprints into
functional antibody and killer T-cell responses. Inovio has
achieved significant antigen-specific immune responses against
multiple diseases and is advancing a growing pipeline of cancer and
infectious disease immunotherapies and vaccines.
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, Regeneron, Genentech, The Wistar Institute, University
of Pennsylvania, DARPA, GeneOne Life Science, Plumbline Life
Sciences, ApolloBio Corporation, 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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, and the sufficiency of 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, 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 including
GLS-5700, 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
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, 2016,
our Form 10-Q for the period ended June 30, 2017, and other
regulatory filings we make from time to time. There can be no
assurance that any product candidate in Inovio's pipeline will be
successfully developed, manufactured or commercialized, that final
results of clinical trials 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. In addition, the forward-looking statements included in
this press release represent Inovio’s views as of the date hereof.
Inovio anticipates that subsequent events and developments may
cause its views to change. However, while Inovio may elect to
update these forward-looking statements at some point in the
future, the company specifically disclaims any obligation to do so,
except as may be required by law. These forward-looking statements
should not be relied upon as representing Inovio’s views as of any
date subsequent to the date of this release.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals,
267-440-4211, jrichardson@inovio.com
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