Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today that the
first participant has been dosed with PENNVAX®-GP in a randomized
clinical trial that will evaluate its ability to drive remission of
HIV infection. This vaccine widely targets all major HIV strains
and the potential to enhance the capacity of the immune system to
eliminate or provide life-long control of HIV. This trial is part
of a previously reported multi-year $6.95 million grant from the
NIH’s National Institute of Allergy and Infectious Diseases (NIAID)
to develop a single or combination therapy using Inovio’s
PENNVAX-GP with the goal of attaining long-term HIV remission.
This Phase 1/2 HIV trial is a randomized,
double-blinded, placebo-controlled study. The trial is divided into
two cohorts and all vaccines are delivered via the CELLECTRA®
device. In the main study (Cohort A), 45 HIV-infected adults who
initiated antiretroviral therapy during chronic infection will
receive either PENNVAX-GP (containing HIV Gag/Pol/Env antigens),
INO-6145 (containing HIV Gag/Pol antigens) or a placebo. Both
vaccines are also co-administered with INO-9012 (IL-12 DNA immune
activator). In the single arm and uncontrolled second study (Cohort
B), individuals who initiated antiretroviral therapy during acute
HIV infection will receive PENNVAX-GP + INO-9012.
Steven G. Deeks, MD, the clinical trial’s
Principal Investigator, and Professor of Medicine in Residence at
the University of California, San Francisco, where the trial is
being conducted, said, “Although we do not expect this or any
vaccine to be curative on its own, we firmly believe that a
therapeutic vaccine will likely be needed as part of a combination
approach. We and others in the field have been very impressed with
what Inovio has accomplished in their vaccine against HPV, which
shares some similarities with HIV, so we are optimistic.”
Kara W. Chew, MD, MS, Assistant Clinical
Professor of Medicine and co-lead of the trial with Dr. Judith S.
Currier at the collaborating University of California, Los Angeles,
added, “We are excited to evaluate the potential of this vaccine to
safely induce the broad HIV-specific immune responses likely needed
to control HIV without antiretroviral therapy.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "We have already demonstrated that PENNVAX-GP generated the
highest overall levels of T cell and antibody immune response rates
ever demonstrated by an HIV vaccine in healthy volunteers.
Here, we are going after the Holy Grail of HIV treatment –
investigating if our vaccine used alone or in combination with
other therapies could bring true remission of HIV in patients.
The key to this trial is that T cells generated by our
vaccines target the body’s HIV reservoirs where the infection
'hides' from antiretroviral therapy. Inovio has already shown (in
an HPV therapeutics trial) that our immunotherapy can generate
sustained T cell responses which are able to traffic to an
immunosuppressive tissue environment and eliminate virus-expressing
cells. We expect results from this breakthrough study in late
2019.”
The primary objectives are to evaluate safety,
tolerability and immunogenicity, with a secondary objective to
determine PENNVAX-GP’s anti-reservoir activity in both cohorts.
Study products will be administered at Day 0 and Weeks 4, 8 and 12.
Participants will be observed on study for up to 64 weeks. Using
standard and innovative measures of immunogenicity, we will
determine the capacity of our vaccine strategies to stimulate
broad, functional T cell responses against novel HIV epitopes, and
comprehensively characterize the impact of the vaccine on several
innate and adaptive immune parameters. The size of the active and
latent reservoirs before and after vaccination will be measured.
For additional information about the study please visit
www.clinicaltrials.gov (search identifier DAIDS-ES 38409).
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.
In May, PENNVAX-GP, in a Phase 1 trial
(HVTN-098) in 94 HIV-negative volunteers, demonstrated durable and
robust immune responses at month 12, a full six months after the
last dose in the study. Inovio previously reported that PENNVAX-GP
elicited the highest overall levels of immune response rates
(cellular and humoral) ever demonstrated in a human study by an HIV
vaccine. To potentially prevent and treat HIV, PENNVAX-GP consists
of a combination of three HIV antigens designed to generate both
antibody and T cell responses and cover multiple global HIV
strains. These clinical study results are being prepared for a
manuscript to be submitted for a publication in a medical
journal.
About HIV Infection
As of the end of year 2016 worldwide, nearly 35
million people had died from HIV-related causes and 36 million were
living with HIV then. 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 HIV-1 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-1 clade C accounts for 48% of worldwide HIV
type 1 cases. It is the most rapidly spreading subtype of HIV.
Although antiretroviral therapy 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’s DNA Immunotherapy
Technology Platform
Inovio is advancing the medical potential of a
unique class of immunotherapy technology. Its DNA-based platform,
which is the foundation for all of Inovio’s products, including
VGX-3100, is unique in its ability to leverage the body’s naturally
existing mechanisms to generate robust, highly targeted immune
responses to prevent and treat disease – and to do so in the body
without harmful side effects. Its SynCon® immunotherapy design and
CELLECTRA® delivery transform novel genetic blueprints into
functional antibody and killer T cell responses. Inovio was the
first to report the activation – in the body – of significant,
antigen-specific functional T cells correlated to statistically
significant efficacy in a placebo-controlled, randomized,
double-blind Phase 2b clinical trial (HPV-related precancer), with
a very favorable safety profile. These data were published in The
Lancet and independently described as a “major breakthrough” in the
field by U.S. National Cancer Institute scientists. Inovio has
achieved significant antigen-specific immune responses against
multiple diseases and is advancing a growing pipeline of cancer and
infectious disease immunotherapies and vaccines.
About Inovio Pharmaceuticals,
Inc.
Inovio is a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. The Inovio technology platform is
designed to activate an individual’s immune system to generate a
robust, targeted T cell and antibody response against targeted
diseases. Inovio is the only immunotherapy company that has
reported generating T cells entirely in vivo in high quantity
that are fully functional and whose killing capacity correlates
with relevant clinical outcomes with a favorable safety profile.
Inovio’s most advanced clinical program, VGX-3100, is in Phase 3
for the treatment of HPV-related cervical precancer. Also in
development are Phase 2 immuno-oncology programs targeting head and
neck cancer, bladder cancer, and glioblastoma, as well as platform
development programs in hepatitis B, Zika, Ebola, MERS, and HIV.
Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Wistar Institute,
University of Pennsylvania, the Parker Institute for Cancer
Immunotherapy, DARPA, GeneOne Life Science, Plumbline Life
Sciences, Drexel University, National Institute of Allergy and
Infectious Diseases, U.S. Army Medical Research Institute of
Infectious Diseases, NIH, HIV Vaccines Trial Network, U.S. Military
HIV Research Program and CEPI. 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, as well as our plans and expectations
regarding the presentation of data at scientific conferences.
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
us or our collaborators, including alternatives that may be more
efficacious or cost effective than any therapy or treatment that we
and our collaborators hope to develop, issues involving product
liability, issues involving patents and whether they or licenses to
them will provide us 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
we can finance or devote other significant resources that may be
necessary to prosecute, protect or defend them, the level of
corporate expenditures, assessments of our 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, 2017, our Quarterly Report on Form 10-Q for the
quarter ended June 30, 2018 and other regulatory filings we make
from time to time. There can be no assurance that any product
candidate in our 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 we undertake 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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