PLYMOUTH MEETING, Pa.,
Dec. 18, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) announced it has initiated a
phase I trial of its hTERT DNA immunotherapy (INO-1400) alone or in
combination with Inovio's IL-12 immune activator (INO-9012) in
adults with breast, lung, or pancreatic cancer at high risk of
relapse after surgery and other cancer treatments. Because high
levels of hTERT (human telomerase reverse transcriptase) expression
are found in 85% of human cancers, Inovio's cancer candidate holds
the potential as a broad spectrum cancer therapeutic.
A previously published study of this product showed that
administration in monkeys, whose TERT is 96% similar to human TERT,
generated strong and broad TERT-specific immune responses and
demonstrated the potential to eliminate tumor cells. Mice immunized
with Inovio's DNA immunotherapy experienced delayed tumor growth,
tumor shrinkage, and longer overall survival compared with
non-immunized mice.
This human trial is an open label, dose escalation study in
subjects with breast, lung, or pancreatic cancer at high risk of
relapse after surgery and other treatments including chemotherapy
and radiation. Approximately 54 subjects will be enrolled into one
of six treatment groups and receive INO-1400 alone or in
combination with INO-9012, Inovio's immune activator. The study
will be conducted at the University of
Pennsylvania's Abramson Cancer Center, which will fund all
site-specific clinical study costs.
Lung, breast, and pancreatic cancer mortality rates are ranked
first, third, and fourth, respectively, among cancer types in
the United States, despite
improvement in detection and treatment. In each of these three
cancer types, significant numbers of patients undergo surgical
resection and adjuvant therapy with an attempt at cure, but only a
fraction remain in remission. This study will evaluate Inovio's
novel immunotherapy with the ultimate goal of reducing the risk of
relapse in these patients.
Robert Vonderheide, MD, DPhil,
said, "The next great wave of oncology advancements will be
treatments which empower the patient's own immune system to seek
and destroy cancer. In this study we will evaluate a new
immunotherapy targeting the hTERT gene found in numerous
cancers." Dr. Vonderheide is Professor of Medicine; Hanna
Wise Professor in Cancer Research; Associate Director for
Translational Research, Abramson Cancer Center; Vice Chief for
Research, Hematology-Oncology Division, Department of Medicine.
Dr. J. Joseph Kim, President and
CEO, said, "We are enthusiastic about the potential use of INO-1400
cancer immunotherapy in multiple major cancers, given that hTERT is
expressed in the vast majority of cancer types yet is rare in
normal cells. INO-1400 therapy adds to Inovio's growing oncology
franchise led by our phase III candidate, VGX-3100, for treating
HPV-related pre-cancers and cancers."
The primary objective of this study is to evaluate the safety
and tolerability of INO-1400 alone or in combination with INO-9012,
delivered intramuscularly in subjects with high-risk breast, lung,
or pancreatic cancer with no evidence of disease after surgery and
adjuvant therapy. The secondary objectives are to evaluate cellular
and humoral immune responses, measure time to disease progression,
and evaluate immunotherapy-induced changes in subjects.
About Inovio's Cancer Immunotherapies
Inovio's DNA-based immunotherapy technology uniquely activates
and multiplies in the body highly potent antigen-specific killer T
cells targeting a specific cancer. The company's technology
provides the most natural interaction with the immune system next
to an actual infection, therefore the activated therapeutic
response remains controlled by the immune system and has to date
not triggered unwanted inflammatory responses. These are ideal
characteristics of an immuno-oncology product. The immune system
uses the same weapons to fight precancerous and cancerous cells –
sometimes the immune system simply requires assistance to mount an
effective immune response. Inovio achieved an industry first
with clinically significant efficacy shown with its VGX-3100 HPV
immunotherapy in a phase II study of cervical precancer. Inovio is
now advancing multiple clinical and R&D stage active
immunotherapies with the potential to address the full spectrum of
precancers and cancers.
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 immune therapies, the
company is advancing a growing preclinical and clinical stage
product pipeline. Partners and collaborators include Roche,
MedImmune, University of Pennsylvania,
DARPA, Drexel University, NIH, HIV Vaccines Trial
Network, National Cancer Institute, U.S. Military HIV Research
Program, 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, 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, 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, our ability to advance
our portfolio of immune-oncology products independently, including
INO-5150, and to commence a phase I clinical trial for INO-5150 in
the first half of 2015, 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, our ability to enter into
partnerships in conjunction with our research and development
programs, 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 September 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.
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.