PLYMOUTH MEETING, Pa.,
Jan. 6, 2015 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
that results from a 12-patient phase I study of Inovio's HIV
immunotherapy, PENNVAX®-B, in HIV-infected patients
revealed that immune response characteristics generated by the
immunotherapy were similar to those observed in HIV-infected
individuals who without treatment do not progress to further stages
of the disease.
These extremely rare individuals who self-regulate their HIV
infection are called "long-term non-progressors" and it is believed
that part of their ability to control infection may lie in their
unique immune responses. In this phase I study, Inovio's HIV
immunotherapy, which had been previously tested only in disease
prevention, drove the expansion of activated HIV-specific CD8+ T
cells with functional characteristics similar to those of long-term
non-progressors.
Results from this clinical study appeared in the peer-reviewed
journal Molecular Therapy, in the article, "Synthetic consensus
HIV-1 DNA induces potent cellular immune responses and synthesis of
granzyme B, perforin in HIV infected individuals," authored by
Inovio researchers and collaborators.
Dr. J. Joseph Kim, President
& CEO of Inovio, said, "These results show the ability of our
HIV immune therapy to activate HIV-specific CD8+ T cells in
infected patients and the potential to go beyond virus
control and reach into reservoirs of the infection to halt
progression of HIV. Based on these initial results, Inovio plans to
conduct a treatment-focused trial with its lead HIV vaccine,
PENNVAX®-GP, that broadly targets globally significant
HIV strains. This therapeutic study will complement our planned
phase I vaccine study of PENNVAX®-GP in healthy
subjects."
HIV targets the immune system, specifically CD4+ T cells, which
are responsible for activating CD8+ killer T cells that can kill
the virus and infected cells. Unfortunately, with fewer CD4+ and
CD8+ T cells, most infected individuals are unable to fight the
virus. Independent studies have shown, however, that some untreated
HIV-infected individuals have controlled viral replication and are
long-term non-progressors (up to 30 years). One reason this may
occur is due to the presence of CD8+ T cells with particular
functional characteristics. While today's commonly used antiviral
drugs can control viral replication, they cannot eliminate the
virus, their long term effect often diminishes, and they have other
associated side effects and disadvantages. Immunotherapies capable
of generating antigen (disease)-specific CD8+ killer T cells are
therefore considered a promising avenue to achieve long term
prevention, viral load control, and elimination of HIV.
Inovio's synthetic immunotherapy technology is very effective at
generating disease-specific killer T cells in the body. In this
phase I study, HIV-infected individuals whose viral load was
already effectively suppressed (below detection level) using a
highly active antiviral therapy (HAART) received a four-dose
regimen of PENNVAX®-B. Investigators observed that
Inovio's HIV immunotherapy, which in a prior published study in
healthy subjects generated best-in-class CD8+ T cell responses,
significantly increased antigen-specific CD8+ T-cell responses in
all patients.
The investigators also observed that the cell-killing substances
granzyme B and perforin (both necessary to kill targeted cells and
viruses) produced by activated CD8+ killer T cells were present in
quantities and characteristics similar to those of long-term
non-progressors. This result mirrors those of the previously
published HIV study as well as those of Inovio's HPV immunotherapy,
which also generated best-in-class functional T cells in a phase I
study and achieved statistically significant clinical efficacy in a
phase II study.
Another striking result of this HIV study was that
PENNVAX®-B increased the number of HIV-specific CD8+
killer T cells displaying the receptor integrin, which is
associated with the ability to carry T cells to the
gastrointestinal tract (GIT). The GIT hosts 40-65% of the body's
total immune cells, hence is the most important target organ for
HIV, which targets CD4+ T cells and hides in "gut mucosa." The
increased presence of integrin suggests the potential of such an
immunotherapy to better fight or eradicate these reservoirs of HIV
infection in the GIT.
The therapy was well-tolerated and did not result in any adverse
events.
About PENNVAX® HIV Vaccines and
Immunotherapies
Human immunodeficiency virus (HIV) is a retrovirus that causes
acquired immunodeficiency syndrome (AIDS), a condition in which
progressive failure of the immune system allows life-threatening
opportunistic infections and cancers to thrive. HIV is classified
into clades, sub-types within which the virus has genetic
similarities. The most prevalent clades are B (found mainly in
North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia).
Inovio completed initial clinical studies focused on its HIV
immunotherapy PENNVAX®-B, targeting clade B viruses, to achieve
proof of principle in generating potent immune responses using its
SynCon® vaccine technology. In two published phase I studies,
PENNVAX®-B administration has been shown to generate high levels of
antigen-specific CD8+ T cells with proper functional
characteristics. This ability to generate high level of
activated CD8+ killer T cells uniquely positions PENNVAX® as an
important product candidate for preventing and treating HIV
infections.
Using a $25 million grant from the
NIH, Inovio designed its multi-clade PENNVAX®-GP immunotherapy
targeting viruses from clades A, B, C and D. PENNVAX®-GP is now
Inovio's lead preventive and therapeutic immunotherapy.
A phase I clinical study of PENNVAX®-GP in a preventive setting
is planned for the first half of 2015. A phase I clinical study of
PENNVAX®-GP as an immune therapy is planned for the second half of
2015.
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.