Grant Provides
Funding to Help Prepare New
Zika Therapy for Human Trials
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that it
has been awarded a $6.1 million sub-grant through The Wistar
Institute to develop a DNA-based monoclonal antibody designed to
provide a fast-acting treatment against Zika infection and its
debilitating effects. The goal of this program, which is funded by
a grant to The Wistar Institute from the Bill & Melinda Gates
Foundation, is for the researchers to develop a Zika dMAb® therapy
ready for human clinical trials in less than two years.
There is no approved therapeutic or vaccine for
Zika infection, presenting a major unmet medical need given that
the World Health Organization estimates that more than two billion
people are directly at risk for infection. Importantly, infection
with the Zika virus during pregnancy can cause a pattern of birth
defects including microcephaly.
This new DNA-based monoclonal antibody
technology has properties that best fit a response to address a
Zika outbreak in that dMAb products can be designed and
manufactured expediently on a large scale using common fermentation
technology, are thermal-stable, and may be used as a therapy to
provide more rapid protection from or limit the spread of Zika
infection. Unlike vaccines, monoclonal antibody-based therapies
could provide more immediate protection but do not develop long
term immune memory. An ideal approach would therefore include the
administration of a dMAb product for immediate protection and a DNA
vaccine to train the immune system for longer-term, persistent
protection against Zika infection. Inovio’s optimized DNA-based
immunotherapy platform is uniquely positioned to target both
immediate therapy through delivery of dMAb products as well as
long-term immunity via DNA vaccination.
Dr. J. Joseph Kim, President & CEO of
Inovio, said, “As the leader in DNA-based immunotherapy and vaccine
products, with our lead program poised to enter phase III study in
the near term, we are also excited to expand our powerful
technology platform to develop these new dMAb products. We thank
the Gates Foundation for their confidence in the Inovio/Wistar team
to develop this new type of medicine to address an emerging
infectious disease like Zika. This grant marks the fourth major
grant in the past couple of years backing the development of
Inovio’s dMAb technology. Past grants include two from DARPA
totaling over $56 million − one for dMAb products for Ebola and one
for dMAb products for universal flu and antibiotic resistant
bacteria − as well as one from the NIH for dMAb products for
treating HIV infection.”
Dr. David B. Weiner, Wistar’s Executive Vice
President, Director of its Vaccine Center, and the W. W. Smith
Charitable Trust Endowed Professorship in Cancer Research, is the
principal investigator of this grant. Other collaborators on the
award include Humabs Biomed and GeneOne Life Sciences. Dr. Weiner
said, “Our team has strong expertise in DNA immunotherapy
development, design and delivery technology as well as molecular
immunology (The Wistar Institute) and DNA production and clinical
studies including device & delivery development (Inovio
Pharmaceuticals) and DNA studies in non-human primates. Our
collaborative team skillset includes monoclonal antibody discovery
(Humabs) and validation, and extensive experience working with in
vivo infectious disease models and challenges (Wistar & Humab).
Each group will perform experiments and provide essential reagents
to other groups within the consortium. The team is experienced with
translation from preclinical studies to the clinic.”
In support of its dMAb technology, the
Inovio/Wistar team reported earlier this year that its dMAb product
for another emerging infectious disease, Chikungunya (CHKV),
provided durable 100% protection in mice. In this study, a single
intramuscular injection of a dMAb product protected mice from a
lethal dose of the virus. The protection expressed by these dMAb
antibodies was very rapid, with 100% survival in mice challenged
with lethal disease as early as two days after dMAb product
administration. In comparison, vaccine-driven protection can take
weeks to months to reach peak efficacy levels, but provides better
long term protection compared to a dMAb product. This published
study demonstrates that an Inovio dMAb product and DNA vaccine
could be used as an ideal combination to provide both rapid
short-term as well as long-term protection. Inovio is the only
organization to report such results in any disease using a
DNA-based monoclonal antibody, with published preclinical data in
dengue and HIV as well, and is also developing dMAb products for
treating MERS, influenza, MRSA, RSV, Ebola and cancers.
Inovio is advancing two trials for its DNA-based
Zika vaccine. It expects to have preliminary results by year end
for its U.S./Canada study. In Puerto Rico, where the CDC estimates
Zika will infect more than 25% of the population by year end,
Inovio’s second study employs a placebo control design that may
provide exploratory signals of vaccine efficacy. The company
expects to meet with regulators next year to determine the most
efficient path forward to develop its Zika vaccine and help
mitigate this widespread Zika outbreak that has now expanded into
the continental United States.
About Inovio’s dMAb
Technology
Unlike conventional monoclonal technology, which
involves constructing protein-based antibodies and manufacturing
them in cell culture in a complex and costly process, Inovio’s
patent-protected DNA-based monoclonal antibody technology encodes
the DNA sequence for a specific monoclonal antibody in a highly
optimized plasmid, which would be delivered directly into a
subject’s arm using electroporation. Cells in the body would then
produce the encoded monoclonal antibody molecules, with intended
functional activity including high antigen-binding and
neutralization capabilities against the targeted disease.
Monoclonal antibodies offer the benefit of inducing a rapid onset
of the immune response. Overall, Inovio’s dMAb technology may
provide clear advantages over conventional monoclonal antibody
technology, including faster development, easier product
manufacturing, and more favorable pharmacokinetics. The current
monoclonal antibody product market is well over $50 billion.
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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