Inovio Fully Enrolls 160 Subjects in Puerto Rico for Second Zika Vaccine Phase 1 Trial; Continues Leadership to Advance an Ef...
June 15 2017 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has completed enrollment of its phase 1 clinical trial in Puerto
Rico evaluating its Zika vaccine, GLS-5700. Inovio is developing
this vaccine with GeneOne Life Science, Inc. (KSE:011000)
and academic collaborators from the US and Canada. This second
phase 1 study (ZIKA-002) was designed to assess safety,
tolerability, and immune responses in the setting of potentially
ongoing disease transmission.
ZIKA-002 study, initiated in 3Q 2016, is a
placebo-controlled, double-blind trial involving 160 healthy adult
volunteers (80 subjects received vaccine and 80 subjects received
placebo) to evaluate GLS-5700 administered with Inovio’s skin
delivery system. Along with safety and immune responses, the study
is also assessing differences in Zika infection rates in
participants given either placebo or vaccine as part of an
exploratory endpoint being evaluated over one year.
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.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Families and babies are terribly affected by Zika and there
is no preventive vaccine or treatment. Similar diseases like dengue
and chikungunya have persisted for decades and infected millions;
while their medical symptoms are arguably less notable than Zika,
their debilitating medical and economic impact has motivated
continuing research and funding support to find viable
immune-related solutions. Inovio is proud to be at the forefront of
Zika vaccine development and to produce foundational data that
clearly supports advancement of DNA technology and our vaccine
candidate. We look forward to the prospect of securing funding for
phase 2 efficacy studies and attaining clarity on the regulatory
pathway necessary to potentially commercialize our Zika
vaccine.”
Inovio was the first in the race to take a
vaccine candidate into clinical studies in 2016. Our ZIKA-001 phase
1 trial was conducted in the US and Canada in 40 healthy
volunteers. In February 2017 Inovio was also the first group to
report positive clinical data: high levels of binding antibodies
were measured in 100% (39 of 39) of evaluated subjects; two doses
or a single dose of vaccine generated a robust antibody response in
95% (37 of 39) and 40% (16 of 40) of evaluated subjects,
respectively. The vaccine was well tolerated and no significant
safety concerns were noted.
Preclinical data published in the peer-reviewed
journals npg Vaccines (2016) and Nature Communications
(2017) showed that GLS-5700 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.
About GLS-5700 Zika Vaccine
Inovio is developing GLS-5700, a DNA vaccine
encoded for pre-membrane and envelope antigens, to provide broad
protective antibody and therapeutic T cell responses against
multiple strains of Zika virus.
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 Pharmaceuticals, Genentech, GeneOne Life
Science, Plumbline Life Sciences, ApolloBio Corporation, The Wistar
Institute, Laval University, University of Pennsylvania, Drexel
University, DARPA, NIH, HIV Vaccines Trial Network, National Cancer
Institute, and U.S. Military HIV Research Program. For more
information, visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop the Zika vaccine GLS-5700, including the conduct
of clinical trials involving this vaccine. Actual events or results
may differ from the expectations set forth herein as a result of a
number of factors, including the availability and timing of data
from ongoing clinical trials, uncertainties inherent in the
completion of ongoing clinical trials and the initiation of future
clinical trials, whether the results of earlier clinical trials
will be indicative of the results of future trials, expectations
for regulatory approvals, the availability of funding to support
continuing research and studies, 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 and other
factors discussed in the “Risk Factors” section of our Annual
Report on Form 10-K for the year ended December 31, 2016, filed
with the U.S. Securities and Exchange Commission (SEC) on March 15,
2017, our Form 10-Q for the quarter ended March 31, 2017, filed
with the SEC on May 10, 2017, and other filings that Inovio makes
with the SEC from time to time. There can be no assurance that any
product candidate in Inovio's pipeline will be successfully
developed or manufactured, 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: 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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