BLUE BELL,
Pa., June 10, 2014
/PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO)
today announced it has initiated a phase I/IIa clinical trial
to evaluate safety, immunogenicity and clinical responses of its
immunotherapy product, INO-3112, in treating human papillomavirus
(HPV)- associated head and neck 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).
In a phase I trial of VGX-3100,
Inovio demonstrated that this immunotherapy produced high levels of
durable T cell immune responses, notably CD8+ "killer" T cells, in
78% of all patients in the study. These CD8+ T cells showed the
functional ability to kill target cells displaying the E6 and E7
antigens. In preclinical animal models,
Inovio's HPV 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, 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 designed to increase the generation of HPV-specific
CD8+ T cells for the treatment of HPV-related cancer.
In this open-label study, called HPV-005, up to twenty
adults with HPV-positive head and neck squamous cell carcinoma
(HNSCC) will be treated with INO-3112 and followed for safety,
immune and clinical responses. In one part of the study, up to ten
patients will be treated with INO-3112 before and after resection
of their tumor. In the second part of the study, up to ten patients
will be treated with INO-3112 after completion of chemotherapy and
radiation therapy. Each INO-3112 treatment will be administered
using Inovio's CELLECTRA® delivery system.
In addition to assessing safety, this study will
analyze T cell immune responses to INO-3112. Pre- and
post-immunotherapy tumor tissue will be analyzed to evaluate
infiltration of T cells into the tumor and tumor bed. Clinical
responses characterized by anti-tumor effects, using RECIST
criteria, and progression free survival will also be
measured.
The study will be conducted at the Abramson Cancer
Center (ACC) in the Perelman School of Medicine (PSOM) at the
University of Pennsylvania, one of the
world's premier cancer treatment center, and led by principal
investigator Charu Aggarwal, MD,
MPH, assistant professor of medicine in the division of
hematology-oncology at the PSOM and ACC.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Initiating this head and neck cancer
study is just the tip of the iceberg in our oncology immune therapy
development plans. Onco-immunotherapy is all about T cells – the
very thing which our products have been shown to
stimulate extremely well. We look forward to our upcoming
unblinded cervical dysplasia phase II study data on efficacy and T
cell responses this summer."
"We will also launch additional cancer
clinical studies to further characterize and expand the potential
of our DNA immune therapy products and immune
activators with their potent abilities to generate and
activate the highest levels of antigen-specific killer T
cells. These include trials for INO-5150 for prostate
cancer with our pharmaceutical partner in Q3 and INO-1400, our
immunotherapy encoded for hTERT in breast, lung and pancreatic
cancer patients later this year. Our goal 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.
Human papillomavirus (HPV) is the most common sexually
transmitted disease in the United
States, infecting 79 million Americans. HPV infection may
lead to cervical dysplasia and cancer as well as cancers of the
anogenital tract. HPV-caused head and neck cancer is
the fastest growing cancer in men and is expected to overtake the
incidence of HPV-caused cervical cancers by the end of this decade.
If proven effective, INO-3112 could augment current
therapeutic approaches to head and neck cancer. Today's therapy for
oropharyngeal (head & neck) cancer is a combination of
chemotherapy, radiation and surgical resection. The treatments have
many potential side effects, including damage to the throat, which
can hinder the ability to speak and swallow.
VGX-3100 and INO-3112 for Treating HPV-Caused
Diseases
Inovio's lead product, VGX-3100, is a DNA-based
immunotherapy for precancers 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.
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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SOURCE Inovio Pharmaceuticals, Inc.