Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the
dosing of the first subject in its multi-center phase I trial to
evaluate Inovio’s Zika DNA vaccine (GLS-5700). In addition to the
previously announced US FDA approval for the conduct of the study,
Health Canada’s Health Products and Food Branch has also approved
this study, which will be conducted at clinical sites in Miami,
Philadelphia, and Quebec City.
This phase I, open-label, dose-ranging study of
40 healthy adult volunteers is evaluating the safety, tolerability
and immunogenicity of GLS-5700 administered with the CELLECTRA®-3P
device, Inovio’s proprietary intradermal DNA delivery device. 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.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “The WHO declared Zika a public health emergency in February
2016 and every week new insights suggest that, similarly to dengue
and Chikungunya, its medical and economic impact may be
significant, pervasive and long-lasting. The U.S. Centers for
Disease Control (CDC) estimates that there are 30 to 40 million
U.S. travelers to Zika-affected areas annually. The resident
population in the Americas at higher risk of Zika exposure has been
estimated at nearly 300 million. It is easy to see the potentially
harmful effect Zika could have and why a safe and effective
vaccine, brought to market as quickly as possible, is critical for
public health.
“Inovio’s synthetic vaccine technology allows
rapid development of new products to stimulate effective immune
responses against targeted infectious diseases and cancers. Our
Zika product has established a record as the fastest-ever vaccine
development from conceptualization through human application,
demonstrating the potential of our SynCon® platform to respond
rapidly to global health emergencies. With enrollment now started,
we expect to complete subject dosing and report interim phase I
results later this year.”
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 into clinical
development.
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. 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 July 2016,
65 countries and territories 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. 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 from
infection 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 breath. Recent reports suggest
Zika may also be linked to other neurological abnormalities.
No vaccine or therapy currently exists for the
prevention or treatment of infection with 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, Roche, 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 University of
Manitoba. 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, but not limited to, the fact that pre-clinical and
clinical results referenced in this release may not be indicative
of results achievable in other trials or for other indications,
that the studies or trials may not be successful or achieve the
results desired, that pre-clinical studies and clinical trials may
not commence or be completed in the time periods anticipated, that
results from one study may not necessarily be reflected or
supported by the results of other similar studies and that results
from an animal study may not be indicative of results achievable in
human studies), 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, our ability to
advance our portfolio of immuno-oncology products independently,
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, our ability to enter into partnerships in
conjunction with our research and development programs, evaluation
of potential opportunities, 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 March 31, 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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