PLYMOUTH MEETING, Pa.,
Sept. 22, 2014 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
it has initiated a phase I clinical trial in patients with
aerodigestive cancers. The trial will evaluate the safety,
tolerability, and immunogenicity of INO-3106. This immunotherapy
targets human papillomavirus type 6 (HPV-6), which causes most
aerodigestive cancers.
Aerodigestive cancers affect the lips, mouth, tongue, nose,
throat, vocal cords, and parts of the esophagus and windpipe. The
unmet need for patients suffering from this form of cancer is
significant.
This study is part of Inovio's strategy to broadly expand
clinical development of its DNA-based immune therapy products to
treat different HPV types and the many diseases they cause. It is a
phase I, open label compassionate study enrolling patients with
invasive cancer who have exhausted all other treatment options
(chemotherapy, radiation and surgery). The study will test Inovio's
immunotherapy, INO-3106, alone or in combination with DNA-based
IL-12, Inovio's proprietary immune activator, in subjects with
HPV-6 associated aerodigestive malignancies. Successful results
could open a path to pursuing an FDA orphan designation (special
status granted for therapies for rare diseases) for aerodigestive
cancers.
Earlier this year, Inovio reported positive top-line phase II
efficacy data for VGX-3100, its SynCon® immunotherapy
targeting pre-cancers and cancers caused by HPV-16 and HPV-18.
VGX-3100 showed the ability to eliminate HPV infection and cause
full regression of high grade cervical dysplasia (CIN 2/3). Inovio
is advancing VGX-3100 into a phase III registration study with
target patient characteristics and a treatment regimen similar to
the phase II study. In addition, Inovio has initiated two separate
studies testing INO-3112 to treat head and neck cancer as well as
inoperable cervical cancer.
Dr. J. Joseph Kim, President and
CEO, said, "Following our phase II success, we are pleased to
expand our HPV franchise with this product and clinical trial
targeting a different HPV type. Our SynCon immunotherapies have
been shown to activate the immune system to bring about
desired
efficacy with a very favorable safety
profile. This makes them well-suited to potentially treat the
broad spectrum of HPV-associated cancers and pre-cancers as well as
HPV itself, which is one of the most prevalent cancer-causing
viruses."
About Inovio's HPV Immunotherapies
Inovio's SynCon® DNA-based immunotherapies help the
immune system activate disease-specific killer T cells to fight a
targeted disease. HPV, the most pervasive sexually transmitted
virus, causes numerous pre-cancers and cancers. Inovio's HPV
immunotherapy called VGX-3100 targets disease associated with the
high-risk HPV types 16 and 18, which are responsible for over 70%
of cervical pre-cancers and cancers. Inovio is currently advancing
this product for cervical pre-cancers. INO-3112 combines VGX-3100
with Inovio's DNA based immune activator encoded for IL-12. This
product is being directed to cervical, head & neck, and
anogenital cancers caused by HPV types 16 and 18. INO-3106 now
extends Inovio's HPV immunotherapy franchise to HPV type 6. Inovio
aims to advance therapies against multiple types of HPV and
HPV-associated diseases.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and
infectious diseases. Our immunotherapies uniquely activate
best-in-class immune responses to prevent and treat disease, and
have shown clinically significant efficacy with a favorable safety
profile. With an expanding portfolio of cancer immunotherapies and
clinical studies, the company is advancing a growing product
pipeline. Partners and collaborators include Roche,
the University of Pennsylvania, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, US Dept. of Homeland Security, 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 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, including safety and efficacy for VGX-3100, 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 immune therapy and vaccine products, 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, 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, 2013, our Form 10-Q for the
quarter ended June 30, 2014, 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.
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CONTACTS:
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Investors:
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Bernie Hertel, Inovio
Pharmaceuticals, 858-410-3101, bhertel@inovio.com
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Media:
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Jeff Richardson,
Inovio Pharmaceuticals, 267-440-4211,
jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.