Inovio will Independently Develop Hepatitis B Immunotherapy
August 03 2016 - 9:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced the
company will continue to develop its hepatitis B DNA immunotherapy
(INO-1800) independently following Roche’s notice that it will
discontinue its collaboration with Inovio and its development of
INO-1800. INO-1800 was licensed to Roche from Inovio in 2013. All
of Roche's rights to INO-1800, including the right to license the
product to other parties, will be returned. Inovio will continue to
advance its current phase I study of INO-1800, which is enrolling
as planned in 30 clinical sites in the U.S. and Asia-Pacific
regions. Inovio anticipates completing enrollment in the first half
of 2017 and expects results in the second half of 2017.
This randomized, open-label, active-controlled,
dose escalation study is evaluating the safety, tolerability, and
immunogenicity of INO-1800, alone or in combination with INO-9112,
Inovio's IL-12-based immune activator in adults with chronic
hepatitis B infection. The primary endpoints are safety and
tolerability. 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 oral
antiviral therapies. The study has completed interim safety reviews
with a favorable safety profile to date. Immunology analyses are
planned after completion of enrollment.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “While we acknowledge Roche’s strategic decision in the area
of hepatitis B, we are optimistic that our potent immunotherapy
platform will make a difference in this globally important chronic
viral infection, similar to what we have demonstrated in
HPV-related disease. Inovio was already managing the phase 1
clinical trial so the study will continue on track without
disruption.”
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. Notably, researchers found that hepatitis B-specific
T cells exhibited a killing function and could migrate to and stay
in the liver and cause clearance of chronically infected cells
without evidence of liver injury. These results indicate that
INO-1800 may have potential to treat chronic hepatitis B
infection.
Hepatitis B and Liver
Cancer
Chronic infection with hepatitis B virus is one
of the major causes and risk factors for liver cirrhosis and liver
cancer. The virus is very infectious, with over 240 million people
chronically infected worldwide. More than 60 million of these
people are at risk of the major complications of liver cirrhosis
and liver cancer, which cause over 700,000 deaths globally each
year.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes 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
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval University. 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, 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
immunotherapy and vaccine products, our ability to advance our
portfolio of immuno-oncology products independently, the ability of
our collaborators to attain development and commercial milestones
for products we license and product sales that will enable us to
receive future payments and royalties, 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, 2015,
our Form 10-Q for the quarter ended March 31, 2016, 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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