Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that its
academic and industry collaborators received a multi-year $6.95
million grant from the NIH’s National Institute of Allergy and
Infectious Diseases to develop a single or combination therapy
using Inovio’s PENNVAX-GP with the goal of attaining long-term HIV
remission in the absence of antiviral drugs.
Although current antiretroviral therapy can
reduce the amount of circulating HIV in the blood to an
undetectable level, latent cellular reservoirs of HIV continue to
exist in the body such that when therapy is discontinued, these
cells begin to produce HIV again. This proof-of-concept clinical
program will test whether enhancing anti-HIV specific CD8 killer T
cell immune responses alone or in combination with other products
can influence the size of the viral reservoir pool, potentially
resulting in reducing or eradicating the virus.
This is a two-step clinical study in
HIV-positive subjects to assess Inovio’s HIV immunotherapy
PENNVAX-GP with INO-9012 (an IL-12 immune activator) alone and with
the addition of a PD-1 checkpoint inhibitor.
All trials will be randomized, double-blind,
placebo-controlled assessments of PENNVAX-GP. They will be
conducted at the University of California in San Francisco and Los
Angeles.
PD-1 checkpoint inhibitors have proven effective
in treating cancer and may have a role in the management of chronic
infectious diseases. This trial seeks to demonstrate that an in
vivo immunotherapy combining a PD-1 inhibitor and PENNVAX-GP will
enhance the CD8 killer T cell response to HIV infected cells.
Development of Inovio’s PENNVAX-GP
immunotherapy, which widely targets multiple major clades of HIV —
providing global coverage — has been funded through a $25 million
NIAID contract awarded to Inovio and its collaborators. In
addition, Inovio and its collaborators were awarded a five-year $16
million Integrated Preclinical/Clinical AIDS Vaccine Development
(IPCAVD) grant in 2015 from NIAID.
PENNVAX-GP is currently being studied in a phase
I trial (HVTN-098) to evaluate safety and immunogenicity in 94
healthy volunteers. In this study, PENNVAX-GP is being evaluated as
a preventive vaccine. The newly funded study will assess the impact
of this vaccine approach in a therapeutic setting.
Steven G. Deeks, MD, the grant and clinical
trial’s Principal Investigator, and Professor of Medicine in
Residence at the University of California, San Francisco, said,
“There is growing recognition that we will need to generate
powerful CD8+ T cells that target vulnerable regions of the virus
and which can migrate to the tissues where the virus hides. The
preliminary data from other Inovio-sponsored studies makes me
enthusiastic that this vaccine might fill an important niche in
future curative strategies.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "We are thrilled to receive this NIH funding to test the
combination of Inovio’s HIV immunotherapy with a PD-1 inhibitor.
Similar to what we are doing in the cancer field with INO-3112 and
INO-5401, we believe that the one-two punch of generating potent
killer T cells with our immunotherapies combined with PD-1/PDL-1
checkpoint therapies could be an important step in generating
functional cure for these diseases.”
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 1 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 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, 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 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 the HIV immunotherapy PENNVAX-GP,
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, 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,
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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