BLUE BELL, Pa., June 23, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) today announced it has
initiated a phase I/IIa clinical trial to evaluate safety,
immunogenicity, clinical responses and disease-free survival of its
DNA immunotherapy product, INO-3112, in treating human
papillomavirus (HPV)-associated cervical cancer. INO-3112 is a
combination of Inovio's lead active immunotherapy product,
VGX-3100, and its proprietary immune activator expressing
interleukin-12 (IL-12). VGX-3100 is currently being evaluated in a
randomized phase II efficacy trial for the treatment of high grade
cervical dysplasia (pre-cancer).
This open-label study, called HPV-004, will evaluate INO-3112 in
20 female subjects with inoperable invasive cervical cancer.
Subjects will receive four treatments of INO-3112 every four weeks
after completion of a standard chemoradiation regimen. Each
INO-3112 treatment will be a combination of 6 mg of VGX-3100 and 1
mg of DNA-based IL-12 delivered together intramuscularly with the
CELLECTRA® delivery system.
As an exploratory analysis, the study team will evaluate
clinical responses at the tumor site (tumor shrinkage or
regression) and assess disease-free survival and disease recurrence
up to 12 months after the initial immunotherapy with Inovio's
INO-3112. Cellular (T cell) immune responses will be analyzed pre-
and post-immunotherapy in the tumor tissue as well as in the
bloodstream.
In a phase I trial of VGX-3100, Inovio demonstrated that this
HPV immunotherapy produced high levels of durable T cell immune
responses, notably CD8+ T cells, in 78% of all patients. These CD8+
T cells showed the functional ability to kill target cells
displaying the antigens E6 and E7. In preclinical animal models,
this DNA-based immunotherapy demonstrated 100% protection against
HPV E6 and E7-expressing tumors and prevented or delayed the growth
of such tumors. The proprietary IL-12 immune activator, called
INO-9012, was previously shown to enhance antigen-specific CD4+ and
CD8+ T cell immune responses to Inovio's PENNVAX® HIV
DNA vaccine in a clinical trial. Inclusion of this DNA-based immune
activator in INO-3112 is intended to further strengthen the
generation of HPV-specific CD8+ T cells to treat HPV-caused
cancer.
This cervical cancer study is being conducted at the
University of Chicago Medical Center
and at the Comprehensive Cancer Center at Silver Cross, IL, where
Dr. Yasmin Hasan, Director of
Gynecological Radiation Oncology and Brachytherapy, is the
principal investigator.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "This study extends our pioneering HPV
immune-based treatment into cervical cancer, the No. 2 cancer
killer of women in the world. Our goal is to fully address the
post-HPV infection immune therapeutics markets, targeting not only
HPV-related cervical pre-cancer but also cervical cancer as well as
head and neck and anogenital cancers."
"Cancer immunotherapy is focused on generating cancer fighting T
cells and freeing them to attack targeted cancer cells. Inovio has
demonstrated that its therapies mobilize more antigen-specific T
cells than any other product on the market or in development. We
look forward to reporting unblinded cervical dysplasia phase II
study data on efficacy and T cell responses by the end of July. Our
aim is to have the best and most extensive pipeline of active
cancer immunotherapies with the potential to seek out and destroy
cancer cells," said Dr. Kim.
HPV and Cervical Cancer
Human papillomavirus (HPV) is the most common sexually
transmitted disease in the United
States, infecting 79 million Americans and causing almost
all cervical cancers. Approximately 12,000 women in the U.S. are
diagnosed with cervical cancer annually and more than 4,000 will
die from the disease. Worldwide, cervical cancer results in about
275,000 deaths per year. Currently available HPV vaccines are
highly effective at prevention; however, they are not intended for
women already infected with HPV or those who already have developed
dysplasia or cancer. Current treatments include surgery (radical
hysterectomy) and/or combination radiation and chemotherapy. These
treatments have many potential damaging side effects.
VGX-3100 and INO-3112 for Treating HPV-Caused
Diseases
Inovio's lead product, VGX-3100, is a DNA-based immunotherapy
for pre-cancers and cancers caused by HPV. This product, without an
immune activator, is currently in a randomized, double-blind phase
II trial evaluating its efficacy and immune responses against
HPV-caused cervical dysplasia. INO-3112 combines this immunotherapy
with a DNA-based IL-12 immune activator to further boost the
targeted immune response against head and neck cancer, cervical
cancer and other cancers.
Inovio's Immune Activators
Immune activators can play a vital role in augmenting
antigen-specific immune responses such as those generated by
Inovio's DNA vaccines. Inovio's portfolio of patent-protected,
DNA-based immune boosters vary in their ability to activate and
enhance therapeutic T cells or preventive antibodies, modulate the
type of immune responses produced by the vaccine, impact durability
of immune responses, and drive immune responses to sites of
infection, e.g. mucosal surfaces. Different immune activators can
therefore play unique roles in achieving desired immune responses
generated by DNA immunotherapies and vaccines. Moreover, while some
protein-based cytokines and chemokines have been shown to have
severe toxicity, likely due to their dosing levels and systemic
delivery, Inovio's DNA-based immune activators and
immunotherapeutics are delivered together at one injection site
with the goal of enabling local production by the body of cytokines
or chemokines, along with antigens that drive immune responses with
disease modifying benefits and no toxic systemic effects.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's
cancers and challenging infectious diseases. Its SynCon®
vaccines, in combination with its proprietary electroporation
delivery, are generating best-in-class immune responses, with
therapeutic T-cell responses exceeding other technologies in terms
of magnitude, breadth, and response rate. Human data to date have
shown a favorable safety profile. Inovio's lead vaccine, a
therapeutic against HPV-caused pre-cancers and cancers, is in phase
II. Other phase I and preclinical programs target prostate, breast,
and lung cancers as well as HIV, influenza, malaria and hepatitis.
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. More information is
available at 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, 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, 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 March 31, 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:
Investors: Bernie
Hertel, Inovio Pharmaceuticals, 858-410-3101,
bhertel@inovio.com
Media: Jeff Richardson, Inovio
Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
SOURCE Inovio Pharmaceuticals, Inc.