Inovio Pharmaceuticals and Roche Initiate Clinical Trial for Inovio's DNA Immunotherapy to Treat Chronic Hepatitis B Infectio...
April 21 2015 - 3:00AM
Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today that it
has initiated a phase I trial to evaluate Inovio's DNA
immunotherapy in patients who are chronically infected with
hepatitis B. In 2013, Roche and Inovio entered into a partnership
to co-develop and commercialize Inovio's hepatitis B immunotherapy.
This trial initiation triggers a $3 million milestone payment from
Roche to Inovio.
This phase I, randomized, open-label, active-controlled, dose
escalation study will evaluate the safety, tolerability, and
immunogenicity of Inovio's hepatitis B immunotherapy, INO-1800,
alone or in combination with INO-9112, Inovio's IL-12-based immune
activator. This international study will enroll patients in the
United States and Asia Pacific region with a primary endpoint of
safety and tolerability of the therapy. The secondary endpoints
will evaluate the cellular and humoral immune response to INO-1800
and investigate the therapy's effect on several viral and antiviral
parameters. All trial subjects are also medicated with
standard-of-care antiviral therapies.
Dr. J. Joseph Kim, President and CEO, said, "We are pleased our
partnership has achieved this initial clinical advance emanating
from the collaborative efforts at Roche and Inovio. While this is
primarily a safety study, we will also investigate our therapy's
impact on antibody and T-cell responses, which will help advance
the product into further trials. Recent developments have
seen several successful drugs built on hepatitis C
treatments. Hepatitis B has a prevalence nearly double that of
hepatitis C and antiviral treatment can control but usually does
not eliminate the virus. A successful immunotherapy for hepatitis B
holds significant potential."
About INO-1800 for Hepatitis B
Inovio has reported preclinical data showing its hepatitis B
immunotherapy (INO-1800) generated strong T-cell and antibody
responses that led to the elimination of targeted liver cells in
mice. These results indicate that the immunotherapy may have
potential in the treatment of hepatitis B infection. In a
preclinical study, researchers found hepatitis B-specific T-cells
exhibited a killing function, and could migrate to and stay in the
liver and cause clearance of target cells without evidence of liver
injury. This was the first study to provide evidence that
intramuscular immunization can induce killer T-cells that can
migrate to the liver and eliminate target cells.
Hepatitis B and Liver Cancer
One of the major causes and risk factors for liver cancer is
infection by hepatitis B. The virus is extremely infectious – 100
times more so than HIV – and 240 million people are chronically
infected worldwide. Hepatitis B contributes to an estimated one
million deaths worldwide each year. Liver cancer is the third most
common cancer and the most deadly, killing most patients within
five years of diagnosis. About 600,000 new cases arise each
year.
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, 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.
CONTACT: 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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