Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced its
DNA-based Zika vaccine (GLS-5700) protected against Zika
virus-induced damage to testes and sperm, and prevented persistence
of the virus in the reproductive tract of all vaccinated male mice
challenged with a high dose of the Zika virus. This preclinical
study data was published in Nature Communications in an article
entitled, “DNA Vaccination Protects Mice Against Zika Virus-Induced
Damage to the Testes,” written by Inovio scientists and
collaborators.
Dr. Gary Kobinger, lead author of the study and
Director of the Centre for Research in Infectious Diseases at Laval
University in Quebec City, Canada, said, “Given that we know that
Zika virus infection can involve the male reproductive tract and
persist in humans for several months after onset of infection, this
preclinical data warrants further examination as a potential means
to reduce Zika virus infection of the male reproductive tract and
the risk of sexual transmission of the
virus.”
Results from a previous preclinical study with
GLS-5700 were published in Nature Partner Journals (npj) Vaccines
and demonstrated that a single dose of Inovio’s Zika vaccine
protected 100% of mice from infection, brain damage and death after
exposure to the virus. Specifically, vaccinated mice were protected
from degeneration in the cerebral cortex and hippocampal areas of
the brain while un-vaccinated mice showed significant degeneration
of the brain after Zika infection. In addition, a single dose of
Inovio’s Zika vaccine also provided 100% protection from the virus
in a study of non-human primates.
In the first-ever human study of a Zika vaccine,
Inovio reported that in its phase I study (ZIKA-001), after a three
dose vaccine regimen with GLS-5700 high levels of binding
antibodies were measured (ELISA) in 100% (39 of 39) of evaluated
subjects. Moreover, 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. Inovio’s second phase I study of
160 subjects in Puerto Rico (ZIKA-002) will complete enrollment
this month. In this randomized, placebo-controlled, double-blind
trial, 80 subjects received vaccine and 80 subjects received
placebo. The study is evaluating the safety, tolerability and
immunogenicity of GLS-5700 and assessing differences in Zika
infection rates between the arms as an exploratory signal of
vaccine efficacy.
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "This published data suggests another avenue of potential
protection against the Zika virus. While detrimental effects on
sperm and fertility have not yet been reported in Zika-infected
human males, persistence of Zika in semen and sperm and sexual
transmission by males has been documented. This new preclinical
data suggests that our Zika vaccine may represent an opportunity to
limit the potential for sexual transmission of the virus. In
addition to our ongoing ZIKA-001 and 002 clinical studies, we are
planning for a larger phase 2 study in our efforts to bring our
Zika vaccine to patients.”
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.
About Zika Virus
First identified in Uganda in 1947, Zika virus
subsequently spread to equatorial Asia and in recent years through
the South Pacific, Hawaii, South America, Central America, and
Caribbean. In 2016, local mosquito-borne transmission occurred in
North America in Florida and 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. Unlike
other flaviviruses, Zika virus can be sexually transmitted. As of
December 2016, 68 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.
The most common symptoms of Zika virus infection
are fever, rash, joint pain, and conjunctivitis. Zika is associated
with birth defects, most notably microcephaly, which arise from
infection during pregnancy. Microcephaly manifests as incomplete
brain development and an abnormally small head. Recent reports
suggest Zika may also be associated with other neurological
abnormalities and abnormalities in other systems including ocular
and cardiac. In adults Zika virus infection is 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.
No vaccine or therapy currently exists for the
prevention or treatment of Zika virus infection.
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 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 cancer immunotherapy 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, 2016,
Form 10-Q for the quarter ended March 31, 2017 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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