Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that the
first patient has been dosed in a phase I trial to evaluate safety
and tolerability of PENNVAX®-GP, Inovio's "universal" DNA vaccine
for HIV. This human study is in collaboration with the HIV Vaccine
Trials Network (HVTN). The trial will measure immune responses
following administration of the vaccine in four groups of healthy
subjects receiving the vaccine with and without an immune activator
(IL-12) and delivered into muscle or skin using Inovio's CELLECTRA®
delivery technology. This study is conducted by the HVTN and funded
by the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH).
Development of the PENNVAX-GP vaccine, which targets multiple
clades of HIV—providing global coverage—has been funded through a
$25 million NIAID contract awarded to Inovio and its collaborators.
Earlier this year, Inovio and its collaborators were awarded a
five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine
Development (IPCAVD) grant from NIAID. This new five-year program
grant was awarded based on a peer-reviewed meritorious proposal by
Dr. David Weiner, from the University of Pennsylvania and chair of
Inovio's scientific advisory board, and Inovio.
Dr. J. Joseph Kim, President and CEO, said, "This latest HIV
vaccine trial will allow us to test our universal HIV vaccine, with
the potential to provide protection against viruses from all major
global clades. This is a major step forward in extending our
clinical experience with the PENNVAX platform and the innovation
developed from our previous PENNVAX human trials. We are confident
that the results of this trial will advance our previous findings
that demonstrated best-in-class cellular immune responses. Inovio
looks forward to continuing our long-standing and fruitful
collaborations with both NIAID and HVTN."
Results from the previous PENNVAX phase I trial, HVTN 080, were
published in Journal of Infectious Diseases in 2013 and showed that
89% (24/27) of subjects developed a robust CD4 or CD8 response. In
addition, immune response rates remained strong and persistent six
months after vaccination. Achieving a robust CD8 T-cell response in
a significant number of patients had been a previous barrier for
HIV researchers. Importantly, PENNVAX was able to generate CD8
T-cell responses with significant magnitude as measured by the HVTN
core laboratory at the Fred Hutchinson Cancer Center, whose assays
have been standardized to evaluate several different vaccine
delivery technologies. Notably, CD4 and CD8 T-cells are both
important in cellular immunity, however, CD8 T-cells are considered
especially integral to fighting cancers and chronic infectious
diseases. The PENNVAX-GP product was developed as a universal HIV
vaccine to expand and improve the coverage of the earlier version
of PENNVAX against multiple divergent virus strains and clades
across the globe.
About HIV Infection
Nearly 36 million people have died from HIV-related causes and
35 million are living with HIV. 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).
HIV clade C accounts for 48% of worldwide and 51% of African-HIV
type 1 cases. It is the most rapidly spreading subtype of HIV.
Although a highly active antiretroviral therapy regimen has
dramatically transformed the treatment of the disease in developed
countries, effective HIV vaccines are needed to stop the spread of
disease and reduce the need for antiretroviral treatments, which
can have harsh side effects and lose their efficacy over time.
About Inovio's PENNVAX® HIV Vaccines and
Immunotherapies
Inovio completed initial clinical studies of its HIV
immunotherapy PENNVAX-B, targeting clade B viruses, to achieve
proof of principle in generating potent immune responses using its
SynCon® immunotherapy technology. In two published phase I studies,
PENNVAX-B immunization generated high levels of activated,
antigen-specific CD8+ killer T cells with proper functional
characteristics. This ability uniquely positions PENNVAX as an
important product candidate for both preventing and treating HIV
infections.
Using a $25 million contract from the NIH, Inovio designed its
universal, multi-clade, multi-antigen PENNVAX GP immunotherapy
targeting the env, gag and pol antigens to provide coverage against
all major HIV-1 clades. PENNVAX-GP is Inovio's lead preventive and
therapeutic immunotherapy for HIV.
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 is generating T cells, in vivo, in high
quantity that are fully functional 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,
Roche, University of Pennsylvania, DARPA, GeneOne Life Science,
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, 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,
our Form 10-Q for the quarter ended June 30, 2015, 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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