Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced it has
initiated a clinical study of its preventive Zika vaccine
(GLS-5700) in 160 subjects in Puerto Rico, where the Zika virus
outbreak has been declared a public health emergency. The CDC
estimates Zika will infect more than 25% of the Puerto Rican
population by year end, providing the potential for this study’s
placebo control design to provide exploratory signals of vaccine
efficacy.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “The rapid progression of the Zika outbreak in Puerto Rico
provides an immediate and unique opportunity to assess a preventive
vaccine in a real world setting. Inovio and its collaborators are
moving ahead with this second Zika vaccine clinical trial to
evaluate safety, immune responses, and possible signals of vaccine
efficacy. If the results are promising, we plan to meet with
regulators in 2017 to map out the most efficient path forward to
develop our Zika vaccine 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 US and Canada who are also working to
advance Inovio’s Ebola and MERS vaccines through clinical
development.
In June, Inovio was the first to commence a
human Zika trial, with sites in the U.S. and Canada. All 40
subjects for the first clinical study have been fully enrolled and
dosed. Inovio expects to report results before the end of this
year.
There are no approved vaccines or therapies for Zika virus
infection. While multiple companies and academic groups have
announced development plans for Zika virus vaccines, only Inovio
and a US government research center have started human clinical
studies.
Inovio’s second clinical study is a
placebo-controlled, double-blind trial involving 160 healthy adult
volunteers (80 subjects will receive vaccine and 80 subjects will
receive placebo) to evaluate the safety, tolerability and
immunogenicity of GLS-5700 administered with Inovio’s CELLECTRA®-3P
device. This proprietary intradermal DNA vaccine delivery device
has been shown to maximize antigen expression and immune responses
in multiple human studies. Inovio will also assess differences in
Zika infection rates in participants given either placebo or
vaccine as part of an exploratory endpoint. In preclinical testing,
this synthetic vaccine induced robust antibody and T cell responses
- the immune responses necessary to fight viral infections - in
small and large animal models.
About the Zika Virus
First identified in Uganda, Zika virus
subsequently spread to equatorial Asia and over the past 10 years
has rapidly spread through the South Pacific and into South
America, Central America, and the Caribbean. 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 can potentially
transmit Zika virus are found throughout the world there is concern
that Zika will continue to spread to new countries and regions. As
of August, 2016, 66 countries and territories reported evidence of
mosquito-borne transmission of the Zika virus since 2015, compared
to 33 countries stated by WHO in their first Zika situation report
in February 2016. Zika can also be sexually transmitted.
The most common symptoms of Zika virus are
fever, rash, joint pain, and conjunctivitis. Zika has been linked
to a severe birth defect called microcephaly which arises in
infants of women infected during pregnancy. Microcephaly is marked
by an abnormally small head and incomplete brain development. Zika
is also associated with Guillain-Barré 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 linked to other neurological abnormalities
and perhaps abnormalities in other body systems.
No vaccine or therapy currently exists for the
prevention or treatment of Zika virus infection.
About GeneOne Life Science
GeneOne Life Science, Inc. is an international
DNA vaccine developer and leading contract manufacturer of DNA
plasmid-based agents for preclinical and clinical trials for global
companies and institutions. It researches and develops DNA vaccines
to prevent and treat incurable diseases in South Korea and
internationally. The company is headquartered in Seoul, South
Korea. VGXI, Inc., GeneOne's wholly-owned manufacturing subsidiary
located in Texas, is the largest pure-play cGMP DNA plasmid
manufacturing facility in the world. VGXI manufactured the Zika
vaccine and other emerging disease vaccines including Ebola and
MERS.
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 June 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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