Inovio’s DNA Immunotherapy Demonstrates Immune Response Results Key in Treating Chronic Hepatitis B Infection
March 14 2018 - 08:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that
interim Phase 1 results show its DNA immunotherapy designed to
treat hepatitis B virus (HBV) infection was safe, well-tolerated
and generated virus-specific T cells, including CD8+ killer T
cells, meeting the objectives of the clinical study. Preliminary
immunology data from the trial revealed that treatment of patients
with INO-1800 resulted in the generation of T cells that recognized
key components of the hepatitis B virus and reacted by making
antiviral cytokines such as Interferon gamma, a protein believed to
be linked to clearance of HBV from the liver. INO-1800 was also
able to activate and expand CD8+ killer T cells that displayed
markers believed to be important for retention in the liver as well
as multiple potential mechanisms for killing virally infected
cells.
Dr. J. Joseph Kim, Inovio’s President & CEO,
said, “Our hepatitis B immunotherapy trial results clearly
demonstrate the potential of INO-1800 as an immunotherapy for this
widespread infection that is a major cause of liver cancer. Key to
my optimism is that INO-1800 drove generation of HBV-specific
killer T cells across all cohorts. We see INO-1800 as a key
immunotherapy component of an effective anti-HBV combination
therapy. We have had discussions with several potential partners
and expect to further advance this product via collaboration or
partnership.”
Although there is an effective prophylactic
vaccine available to prevent infection, more than 240 million
people are living with chronic HBV infection globally, and the
disease is causing more than one million deaths annually. Currently
available antiviral treatments are not adequate to clear this
infection and may only slow progression of the disease. HBV can
cause chronic infection and puts people at high risk of death from
cirrhosis and liver cancer. These latest results from our Phase 1
trial indicate that treatment with INO-1800 is generating the type
of immune response considered to be key in the treatment of chronic
hepatitis B infection using an immunotherapy.
This open-label, dose escalation study evaluated
the safety, tolerability, and immunogenicity of INO-1800, alone or
in combination with INO-9112, Inovio's IL-12-based immune
activator, in 90 adults with chronic hepatitis B infection. The
primary endpoints were safety and tolerability. The secondary
endpoints evaluated the cellular and humoral immune response to
INO-1800 and investigated the therapy's effect on several viral and
antiviral parameters. All trial subjects, including the ones
in the control group, were also medicated with standard-of-care
oral antiviral therapies during the study. Inovio plans to report
additional data from this trial at upcoming scientific conferences
and in a publication.
In a previously published preclinical study,
Inovio researchers found the vaccine-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 animal study 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, demonstrating the
potential of this immunotherapy.
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– 100 times more so than HIV –
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. Liver cancer is the third
most common cancer and the most deadly, killing most patients
within five years of diagnosis.
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, Regeneron, Genentech, The Wistar Institute, University
of Pennsylvania, the Parker Institute for Cancer Immunotherapy,
DARPA, GeneOne Life Science, Plumbline Life Sciences, ApolloBio
Corporation, 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, including the planned initiation
and conduct of clinical trials and the availability and timing of
data from those trials, and the sufficiency of 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, 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 pipeline of SynCon® active immunotherapy and vaccine
products, 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, 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, 2016, our Form 10-Q for the period
ended September 30, 2017, and other regulatory filings we make from
time to time. There can be no assurance that any product candidate
in Inovio's pipeline will be successfully developed, manufactured
or commercialized, that final results of clinical trials 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. Forward-looking statements speak
only as of the date of this release, and Inovio undertakes no
obligation to update or revise these statements, except as may be
required by law.
CONTACTS:
Investors: Ben
Matone, Inovio, 484-362-0076, ben.matone@inovio.comMedia:
Jeff Richardson, Inovio, 267-440-4211, jrichardson@inovio.com
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