Inovio Pharmaceuticals Zika Vaccine Protects Animals from Infection, Brain Damage and Death
November 10 2016 - 10:00AM
Article published in npj Vaccines demonstrates that DNA
vaccine protected 100% of animals from Zika infection after
exposure to the virus
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that
Inovio and its collaborators have published results in Nature
Partner Journals (npj) Vaccines demonstrating that its Zika DNA
vaccine (GLS-5700) protected animals from infection, brain damage
and death. In this study 100% of GLS-5700 vaccinated animals were
protected from Zika infection after exposure to the virus. In
addition, vaccinated mice were protected from degeneration in the
cerebral cortex and hippocampal areas of the brain while
unvaccinated mice showed significant degeneration of the brain
after Zika infection.
Prior preclinical studies have tested potential
Zika vaccine candidates in animal models involving normal mice and
non-human primates that are naturally resistant to Zika. While
providing useful immunology data, they cannot provide relevant
evidence of an effective means of controlling the spread or medical
impacts of this disease by vaccination. In addition to reporting
immunogenicity in such Zika-resistant species, this paper
represents the first published research to also analyze a Zika
vaccine using the special transgenic murine strain A129 lacking
interferon alpha and beta receptors (IFNAR-/-), making them highly
susceptible to Zika infection and disease. Taking this extra step
provided data on how vaccine-generated immune responses could
protect against a lethal viral challenge and demonstrates the
benefit a Zika vaccine might provide in people.
Dr. J. Joseph Kim, President and CEO of Inovio,
said, “We clearly demonstrated the power and speed of our product
development platform when we and our collaborators moved our Zika
vaccine from the bench to human clinical studies in less than six
months, a vaccine industry record. We’re pleased to now build
further evidence of the potential utility of our product.”
“Our results support the critical importance of
immune responses for both preventing infection as well as
ameliorating disease caused by the Zika virus,” said lead
researcher David B. Weiner, Ph.D., Executive Vice President and
Director of the Vaccine Center at The Wistar Institute and the W.W.
Smith Charitable Trust Professor in Cancer Research at Wistar. Dr.
Weiner is also a member of Inovio’s board of directors and chairs
its scientific advisory board. “As the threat of Zika continues,
these results further encourage the study of this vaccine as a
preventative approach for protecting humans.”
This study demonstrated that Inovio’s synthetic
DNA vaccine expressed antigens specific to Zika and generated
robust antigen-specific and neutralizing antibody and T cell
responses in mouse and non-human primate models. Moreover, the
study also demonstrated that GLS-5700 provided protection against
the disease and death in Zika-susceptible A129 transgenic mice
while also being neuroprotective, meaning the disease was unable to
spread to the brain. This is especially important given the risk
that babies born with the disease have of developing microcephaly,
a birth defect resulting in an abnormally small head and that may
prevent the brain from developing properly.
This Zika vaccine was developed in a
collaboration between Inovio Pharmaceuticals, Inc., The Wistar
Institute, and GeneOne Life Science Inc. and is currently in two
human clinical studies. Inovio expects to report phase I data
before the end of this year from the first 40-subject study being
conducted in Miami, Philadelphia and Quebec City. In August, the
companies initiated a second study of GLS-5700 in 160 subjects in
Puerto Rico. The CDC estimates that Zika will infect more than 25
percent of the Puerto Rican population by the end of the year,
providing the potential for this study’s placebo control design to
provide exploratory signals of vaccine efficacy in 2017.
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 September 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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