BLUE BELL, Pa., Jan. 23, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) today unveiled that the
company has developed a new DNA-based cytokine immune activator,
interleukin -33 (IL-33), that in combination with optimized DNA
vaccines delivered by electroporation increased the potency and
efficacy of the therapeutic response to the DNA vaccines in a
preclinical study. The findings of this study reveal that IL-33
could be an effective immune booster when used with Inovio's
products to generate therapeutic immune responses against cancers
and chronic viral infections in humans. Inovio has developed a
portfolio of patent-protected IL-33 and other immune activators to
form combination therapies with its DNA vaccines and
immunotherapies with the goal of achieving the greatest possible
efficacy against targeted diseases.
A therapeutic vaccine study treating HPV-16 based cancer-bearing
mice demonstrated rapid and complete tumor regression after
treatment with Inovio's HPV16 (human papillomavirus type 16)
vaccine in combination with DNA-based IL-33. Both were delivered
using Inovio's CELLECTRA® electroporation device. Previous studies
have shown that the HPV 16 DNA vaccine alone was able to prevent
tumor growth in mice and delay progression or cure mice of tumors.
Addition of the IL-33 immune activator resulted in a more rapid and
complete regression of established tumors in the mouse model.
The adjuvant/vaccine combination induced potent CD4 and CD8 T
cells. Notably, inclusion of the DNA-based IL-33 immune activator
significantly increased the magnitude of vaccine-specific CD8 T
cell responses. Prior research has demonstrated that CD4 and CD8 T
cells are both important in cellular immune responses; however, CD8
T-cells, or killer T cells, are considered especially integral to
fighting cancers and chronic infectious diseases.
The peak vaccine-induced expansion of CD8 T cells at 14 days
after vaccination correlated with complete tumor regression. This
desirable outcome points to the important role IL-33 and other
immune activators may play in combination with Inovio's cancer
treatments in development.
The results of this study, conducted by Inovio scientists and
collaborators, are detailed in a paper entitled: "Alarmin IL-33
acts as potent immunoadjuvant enhancing antigen-specific
cell-mediated immunity and inducing potent anti-tumor immunity,"
published in Cancer Research.
Dr. J. Joseph Kim, Inovio's
President and CEO, said: "To create the most effective arsenal of
therapeutic products against cancer and infectious diseases, we are
researching combination therapies using our DNA immunotherapies
with checkpoint inhibitors and immune activators to optimize their
therapeutic effects. While we have already reported best-in-class T
cell responses from two DNA vaccines in human trials, this
published study shows for the first time how DNA-based IL-33 can
boost antigen-specific immune responses generated by our DNA
immunotherapies and vaccines.
"We are developing multiple DNA plasmid based cytokine and
chemokine genes as immune activators and I am proud to say that
Inovio has more of these immune activators in its pipeline than
anyone else in the world. We have initiated human studies using
other DNA-based cytokines and look forward to moving IL-33 into
clinical trials in combination with our DNA vaccines," Dr. Kim
added.
About 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
immune boosters vary in their ability to enhance (activate)
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 and systemic delivery,
Inovio's DNA-based cytokines and chemokines are delivered together
with the vaccines as DNA plasmids and are produced locally at the
injection site to drive the production of immune responses without
systemic effects.
Inovio has deployed two different DNA immune activators in human
studies with electroporation delivery. Inovio previously reported
that in a published clinical study its DNA-based IL-12 immune
activator enhanced antigen-specific T cell immune responses from
its HIV DNA vaccine, PENNVAX®. In that study, 89% of the subjects
who received IL-12 DNA together with the PENNVAX® DNA vaccine
delivered with electroporation produced a vaccine specific CD4+ or
CD8+ T cell response compared to 67% who received the DNA vaccine
alone without the IL-12 DNA. To exploit these boosting properties,
Inovio plans to test its cancer immunotherapy products in
combination with DNA IL-12 in upcoming cancer trials. Additionally,
a second cytokine based DNA immune activator, Inovio's DNA-based
IL-28, in combination with its multi-antigen hepatitis C DNA
vaccine, INO-8000, is being tested in a phase I study in HCV
patients. Inovio has in its portfolio over ten (10) important
cytokine and chemokine genes which have shown in preclinical
studies to boost either T cell or antibody-based immune responses
to the vaccines and therapies.
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, Merck, NIH, HIV
Vaccines Trial Network, National Cancer Institute, U.S. Military
HIV Research Program, University of Southampton, US Dept. of
Homeland Security, University of
Manitoba and PATH Malaria Vaccine Initiative. 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, 2012, our Form
10-Q for the quarter ended September 30,
2013, 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:
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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.