New study expands VGX-3100 program for
evaluating therapeutic applications in
HPV-related pre-cancers with high medical need
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has commenced a phase 2 trial to evaluate the efficacy of VGX-3100
in patients with pre-cancerous lesions of the vulva, or vulvar
intraepithelial neoplasia (VIN). VGX-3100 is an immunotherapy that
targets human papillomavirus (HPV) 16 and 18 and is being studied
for the treatment of HPV-related pre-cancerous lesions and
persistent HPV infection that causes these lesions.
VIN has a very low rate of spontaneous, or
natural, regression − below 5%. Currently there are no FDA approved
non-surgical treatments for pre-cancerous lesions of the vulva.
Surgery, the most common treatment, is associated with high rates
of disease recurrence and can cause disfigurement, long-term pain,
and psychological distress for the women who undergo the procedure.
VIN recurs in approximately one of every two patients who undergo
surgical treatment.
This randomized, open label phase 2 study will
assess the efficacy of VGX-3100 in 36 women with high-grade
HPV-related vulvar lesions. The immunotherapy will be administered
with Inovio’s CELLECTRA® intramuscular delivery device. The primary
endpoint of the study is histologic clearance of high-grade lesions
and virologic clearance of the HPV virus in vulvar tissue samples.
The study will also evaluate safety and tolerability of
VGX-3100.
Inovio’s immunotherapy aims to address the unmet
medical need for VIN by providing a non-surgical option for women
with this disease. In a previously conducted phase 2b randomized,
placebo controlled study of 167 women with HPV-associated cervical
pre-cancer, VGX-3100 led to a significantly higher rate of lesion
regression and clearance of the underlying HPV viral infection.
Inovio plans to initiate a phase 3 study of VGX-3100 as a treatment
for high grade cervical dysplasia in 2017, and the treatment of VIN
represent an important additional indication for its lead
product.
Dr. Robert Edwards, Chair of Obstetrics and
Gynecology at the University of Pittsburgh School of Medicine at
Magee-Women’s Hospital and Professor of Medicine in the Department
of Obstetrics, Gynecology, and Reproductive Sciences at the
University of Pittsburgh, School of Medicine, said, “HPV-induced
VIN is one of the major causes of morbidity for young and
middle-aged women with HPV-induced pre-cancer. It is
associated with repetitive need for surgery, multiple biopsies, and
a major cause of pain and sexual dysfunction."
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Inovio’s VGX-3100 may provide the first approved
non-surgical treatment option for women with this HPV-related
pre-cancer with a high recurrence rate. My optimism is based on our
phase 2b efficacy results finding clearance of lesions and the HPV
virus in many subjects in our evaluation of VGX-3100 in women with
high grade cervical dysplasia. Our ultimate goal is for
VGX-3100 to become the “go-to” immunotherapy to treat all major
HPV-related premalignant diseases.”
About Vulvar Pre-Cancers
If left untreated vulvar pre-cancers can
progress to invasive cancer of the vulva. Approximately 27,000
cases of HPV-related vulvar pre-cancers occur in the U.S. each year
and about 12,000 to 24,000 cases in Europe each year. HPV-16 and/or
HPV-18 are involved in about 80% of HPV-related vulvar pre-cancers
cases in the U.S. and Europe. Once vulvar pre-cancers develop,
spontaneous regression (i.e. natural disappearance of the lesion)
is rare and occurs in 1.5% to 5% of cases. An estimated 6,000 new
cases of vulvar cancer occur in the U.S. each year with about 50%
to 80% of those being HPV-associated. About 1,110 deaths occur
annually due to vulvar cancer in the U.S. Standard of care
treatment of vulvar pre-cancer usually involves surgery, which has
significant physical and psychosocial impacts in women (e.g. severe
pain, disfigurement, sexual dysfunction), and the success of such
surgery is marginal, as the recurrence rate of high grade vulvar
pre-cancer is extremely high, i.e. about 50% three years
post-treatment.
About VGX-3100
VGX-3100 is an HPV-specific immunotherapy that
is being developed as a non-surgical treatment for high-grade
HPV-caused pre-cancers and other related underlying persistent HPV
infections. VGX-3100 works in vivo to activate functional,
antigen-specific, CD8 killer T-cells to clear persistent HPV
infection and cause regression of pre-cancerous lesions. In a phase
2 trial to treat cervical dysplasia, VGX-3100 demonstrated clinical
efficacy and was generally well tolerated, without the side effects
and obstetric risks associated with surgical excision. VGX-3100 is
a first-in-class HPV-specific immunotherapy that targets the
underlying cause of HPV-related pre-cancers, providing an
opportunity for women to reduce their risk of cervical cancer
without undergoing an invasive surgical procedure.
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. The company is advancing an expanding
product pipeline in both early and late stage clinical studies.
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 immunotherapy VGX-3100, 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
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Sep 2024 to Oct 2024
Inovio Pharmaceuticals (NASDAQ:INO)
Historical Stock Chart
From Oct 2023 to Oct 2024