Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has commenced its phase 3 clinical program to evaluate the efficacy
of Inovio’s DNA-based immunotherapy, VGX-3100, to treat cervical
dysplasia caused by human papillomavirus (HPV). Inovio’s study will
assess the efficacy of VGX-3100 in regressing cervical HSIL
(high-grade squamous intraepithelial lesions), a direct precursor
to cervical cancer, and eliminating the HPV infection that causes
these lesions. The pivotal data from this program will support the
potential licensure of VGX-3100 as the first immunotherapy for this
disease.
Inovio satisfied the FDA’s request for
information relating to its CELLECTRA® 5PSP delivery device,
resulting in the FDA removing the clinical hold on this program.
Inovio plans to immediately begin recruiting patients for the phase
3 trial.
Inovio’s phase 3 program, named REVEAL
(Randomized Evaluation of VGX-3100 and Electroporation for the
Treatment of Cervical HSIL), will consist of a primary study
(REVEAL 1) and confirmatory study (REVEAL 2), as per FDA general
guidance for phase 3 programs, to be conducted in parallel. The
studies will each enroll 198 patients in more than 100 study
centers globally. Mark Einstein, MD, MS, FACS, FACOG, Professor and
Chair Department of Obstetrics, Gynecology and Women’s Health
Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical
School, is Principal Investigator for the studies.
The REVEAL studies are prospective, randomized
(2:1), double-blind, placebo-controlled trials evaluating adult
women with HPV 16/18 positive biopsy-proven cervical HSIL,
otherwise known as cervical intraepithelial neoplasia (CIN) 2 or 3.
The primary endpoint is regression of cervical HSIL AND virologic
clearance of HPV-16 and/or HPV-18 in the cervix. The studies will
evaluate cervical tissue changes at approximately 9 months after
beginning a three dose regimen of VGX-3100 administered at months
0, 1, and 3. Secondary endpoints include safety; tolerability;
regression of CIN 2/3 to CIN 1 or normal; virologic clearance of
HPV; efficacy measured by non-progression to cancer; and clearance
of HPV from non-cervical anatomic locations.
VGX-3100 has the potential to be the first
treatment for HPV infection of the cervix and the first
non-surgical treatment for pre-cancerous cervical lesions. VGX-3100
stimulates a specific immune response to HPV-16 and HPV-18,
targeting the infection and destroying pre-cancerous cells. There
are no treatments available for HPV infection and surgery is the
only approved treatment for cervical HSIL. While surgery is
effective at removing dysplastic lesions, it does not treat the
underlying HPV infection and carries increased risk of cervical
incompetence and pre-term birth, which can result in fetal
morbidity and mortality. VGX-3100 demonstrated in a phase 2b study
(published in The Lancet) its ability to clear HPV-16 and HPV-18
infection and pre-cancerous lesions.
Dr. Mark Bagarazzi, Inovio’s Chief Medical
Officer, said, “Despite the availability of preventive HPV vaccines
for over a decade, HPV-related cervical HSIL and cancers remain a
widely prevalent problem. Unfortunately, current treatments
are invasive and do not address the underlying HPV
infection. VGX-3100 has the potential to be a first-in-class
HPV-specific immunotherapy offering women the prospect of
preventing cervical cancer without undergoing an invasive surgical
procedure that may compromise their reproductive health. We are
pleased to be able to immediately begin recruiting patients at the
first 15 sites by the end of this month.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Initiating our REVEAL phase 3 program marks a milestone for
Inovio, for the next generation of DNA-based immunotherapies, and
for women’s health. Combining this first phase 3 program with our
previously announced phase 2 clinical trial of VGX-3100 for
HPV-related vulvar neoplasia and our checkpoint inhibitor-based
combination study with MedImmune/AstraZeneca targeting HPV
associated cancers, Inovio is well positioned to comprehensively
treat HPV-associated diseases across the continuum of HPV infection
through to cancer in both men and women. Adding our recently
announced collaborative immuno-oncology combination studies with
Regeneron and Genentech, 2017 is a transformative year that is
laying the foundation for multiple opportunities for important
efficacy data.”
About HPV and Cervical HSIL
HPV is the most common sexually transmitted
infection, with over 14 million new infections annually. While many
of these are transient infections, persistent high-risk infections
can cause the formation of pre-cancerous lesions. Left untreated,
women diagnosed with cervical HSIL are at increased risk of
developing cervical cancer. HPV types 16 and 18 are responsible for
70% of cervical cancers, with more than 400,000 new cases of HPV
16/18 cervical HSIL annually in the US and Europe. Cervical cancer
is a major global health problem, causing 260,000 deaths annually.
While cervical HSIL and cervical cancer are the most well-known HPV
related diseases, HPV is also a major cause of HSIL and cancer in
the entire anogenital region and oropharynx. Currently there are no
treatments available for HPV infection and surgery is the only
approved treatment for cervical HSIL. While surgery is effective at
removing lesions, it does not treat the underlying HPV infection
and it carries increased risk of cervical incompetence and pre-term
birth, which can result in fetal morbidity and mortality.
About VGX-3100
VGX-3100 is a DNA-based immunotherapy under
investigation for the treatment of HPV-16 and HPV-18 infection and
pre-cancerous lesions of the cervix (phase 3) and vulva (phase 2).
VGX-3100 has the potential to be the first approved treatment for
HPV infection of the cervix and the first non-surgical treatment
for pre-cancerous cervical lesions. VGX-3100 works by stimulating a
specific immune response to HPV-16 and HPV-18, which targets the
infection and causes destruction of pre-cancerous cells. In a
randomized, double-blind, placebo-controlled phase 2b study in 167
adult women with histologically documented HPV 16/18 cervical HSIL
(CIN2/3), treatment with VGX-3100 resulted in a statistically
significantly greater decrease in cervical HSIL and clearance of
HPV infection vs. placebo. The most common side effect was
injection site pain, and no serious adverse events were reported.
VGX-3100 utilizes the patient’s own immune system to clear HPV-16
and HPV-18 infection and pre-cancerous lesions without the
increased risks associated with surgery, such as loss of
reproductive health and negative psychosocial impacts.
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 pre-cancer), 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 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 Pharmaceuticals, Genentech, GeneOne Life
Science, Plumbline Life Sciences, ApolloBio Corporation, The Wistar
Institute, Laval University, University of Pennsylvania, Drexel
University, DARPA, NIH, HIV Vaccines Trial Network, National Cancer
Institute, and U.S. Military HIV Research Program. For more
information, visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to conduct phase 3 clinical trials for VGX-3100 for the
treatment of cervical dysplasia caused by HPV, a phase 2 clinical
trial of VGX-3100 for HPV-related vulvar neoplasia and other
immuno-oncology combination studies. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including the availability and timing of data
from ongoing clinical trials, uncertainties inherent in the
completion of ongoing clinical trials and the initiation of future
clinical trials, whether the results of earlier clinical trials
will be indicative of the results of future trials, expectations
for regulatory approvals, the availability of funding to support
continuing research and studies, 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 and other
factors discussed in the “Risk Factors” section of our Annual
Report on Form 10-K for the year ended December 31, 2016, filed
with the U.S. Securities and Exchange Commission (SEC) on March 15,
2017, our Form 10-Q for the quarter ended March 31, 2017, filed
with the SEC on May 10, 2017, and other filings that Inovio makes
with the SEC from time to time. There can be no assurance that any
product candidate in Inovio's pipeline will be successfully
developed or manufactured, 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.
In addition, the forward-looking statements
included in this press release represent Inovio’s views as of the
date hereof. Inovio anticipates that subsequent events and
developments may cause its views to change. However, while Inovio
may elect to update these forward-looking statements at some point
in the future, the company specifically disclaims any obligation to
do so, except as may be required by law. These forward-looking
statements should not be relied upon as representing Inovio’s views
as of any date subsequent to the date of this release.
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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