PLYMOUTH MEETING, Pa.,
July 8, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today
that it has completed enrollment in its Phase 2 trial with VGX-3100
in patients with precancerous 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 precancerous lesions and the HPV
infection that causes these lesions. Inovio is already evaluating
VGX-3100 in two Phase 3 registration trials (REVEAL 1 and REVEAL 2)
to treat cervical dysplasia caused by HPV.
This randomized, open-label Phase 2 study will assess the
efficacy of VGX-3100 in 33 women with high-grade HPV-related vulvar
lesions. The immunotherapy is administered with Inovio's CELLECTRA®
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. The company intends to report interim
clinical data from this study before year's end.
Dr. Prakash Bhuyan, MD PhD, VP,
Clinical Development and the Lead for the VGX-3100 Program, said,
"Inovio is developing VGX-3100 to be the first, comprehensive
non-surgical treatment option for HPV-related precancer.
Surgical treatment of VIN is often disfiguring, and recurrence
occurs in approximately one third of women. The enrollment of
our US-based Phase 2 study of VIN exemplifies the outstanding
commitment of our Investigators and their patients to making it
possible to improve the current standard of care for VIN and
ultimately reduce the occurrence of vulvar cancer."
VIN has a very low rate of spontaneous, or natural, regression −
below 5%. Currently there are no FDA-approved non-surgical
treatments for precancerous 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.
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 is currently conducting a
Phase 3 study of VGX-3100 as a treatment for high grade cervical
dysplasia, and the treatment of VIN represents an important
additional indication for the lead product.
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 with a similar
number of estimated 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 30 to
50% three years post-treatment.
About VGX-3100
VGX-3100 is a DNA-based immunotherapy under investigation for
the treatment of HPV 16 and HPV 18 infection and precancerous
lesions of the cervix (Phase 3) and vulva and anus (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 precancerous 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 precancerous 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 precancerous
lesions without the increased risks associated with surgery, such
as loss of reproductive health and negative psychosocial
impacts.
About Inovio Pharmaceuticals Inc.
Inovio is an innovative biotechnology company focused on the
discovery, development, and commercialization of its synthetic
nucleic technology targeted against cancers and infectious
diseases. Inovio's proprietary technology platform applies antigen
sequencing and delivery to activate potent immune responses to
targeted diseases. The technology functions exclusively in vivo,
and has been demonstrated to consistently activate robust and fully
functional T cell and antibody responses against targeted cancers
and pathogens. Inovio's most advanced clinical program, VGX-3100,
is in Phase 3 for the treatment of HPV-related cervical pre-cancer.
Also in development are Phase 2 immuno-oncology programs targeting
HPV-related cancers, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include AstraZeneca, Regeneron,
Roche/Genentech, ApolloBio Corporation, GeneOne Life Science, The
Bill & Melinda Gates Foundation, Coalition for Epidemic
Preparedness Innovations, Defense Advanced Research Projects
Agency, National Institutes of Health, National Institute of
Allergy and Infectious Diseases, National Cancer Institute, HIV
Vaccines Trial Network, Walter Reed Army Institute of Research, The
Wistar Institute, and the University of
Pennsylvania. For more information, visit
www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA-based immunotherapies, 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. 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 immunotherapies, 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, 2018, our Quarterly Report on Form
10-Q for the quarter ended March 31,
2019 and other filings we make from time to time with the
Securities and Exchange Commission. 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 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.
Inovio Pharmaceuticals Inc.
Investors
|
Media
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Ben
Matone
|
Jeffrey C.
Richardson
|
1-484-362-0076
|
1-267-440-4211
|
ben.matone@inovio.com
|
jrichardson@inovio.com
|
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SOURCE Inovio Pharmaceuticals, Inc.