PLYMOUTH MEETING, Pa.,
Aug. 19, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) announced today that it has
completed enrollment in the company's open-label, 24 patient, Phase
2 trial with its lead immunotherapy product VGX-3100 in patients
with precancerous lesions of the anus, i.e. anal high-grade
squamous intraepithelial lesions (anal HSIL, aka anal
intraepithelial neoplasia). 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 to treat cervical
dysplasia caused by HPV, for which the company has previously
announced the completion of enrollment for the first of those
pivotal trials, REVEAL 1.
This open-label, multi-center Phase 2 study is designed to
evaluate the safety and efficacy of VGX-3100 administered Inovio's
CELLECTRA® delivery system in adult men and women with
anal HSIL caused by HPV-16 and/or HPV-18 and builds on significant
clinical benefits demonstrated with Inovio's HPV immunotherapies in
multiple clinical trials. VGX-3100 in a Phase 2 proof-of-concept
trial for cervical dysplasia demonstrated a complete response in 43
out of 107 patients in regression of high grade cervical lesions
and elimination of the underlying HPV infection. Additional 2 out
of 4 metastatic head and neck cancer patients treated with MEDI0457
and a PD-1 check point inhibitors in a Phase 1 study experienced a
long-term complete response for more two years and counting. The
other 18 out 22 head and neck patients treated with MEDI0457 have
not progressed for over 4 years post-treatment. Lastly, a
pilot study of Inovio's immunotherapy in recurrent respiratory
papillomatosis (RRP) resulted in 2 out of 2 patients delaying
surgery due to lack of tumor recurrence.
Dr. J. Joseph Kim, Inovio's
President and CEO, said, "We are very excited to expand the target
indication for VGX-3100 to treat rare and difficult to treat
diseases like anal HSIL, which have a high recurrence rate that
requires multiple, repeat surgeries. A new immunotherapy that could
effectively eliminate or delay surgery could be transformative for
patients with this high unmet medical condition, Inovio plans to
report preliminary efficacy and safety data from this Phase 2 study
in the fourth quarter."
Anal HSIL or dysplasia is an orphan disease and the precursor to
anal cancer, which is estimated to cause more than 1,280 deaths in
the United States in 2019. Anal
HSIL is estimated to occur in nearly 20,000 new cases
annually. However, that is very likely an underestimate given
that no validated screening test exists for the condition and no
national registry or reporting exists. Currently, the only
treatments for anal dysplasia consist of surgical excision,
electro-cautery or laser therapy, but up to 50% of those treated
with these current treatments experience recurrence of the disease
within one year of treatment and up to nearly 70% within three
years of treatment. Therefore, many patients with this condition
need multiple treatments. Anal HSIL can lead to HPV-associated
squamous cell carcinoma of the anus (SCCA).
Anal cancer is uncommon in the general population, but its
incidence is considerably increasing – 64% higher since 1992 -- and
is higher among women than in men overall and higher in
HIV-positive men and women than in HIV-negative persons. The risk
of SCCA among HIV-positive men has continued to increase even after
the introduction of highly active antiretroviral therapy. Anal
cancer is estimated to have 8,300 new cases diagnosed in
the United States in 2019.
About VGX-3100
VGX-3100 is a DNA-based immunotherapy under Phase 3
investigation for the treatment of HPV-16 and HPV-18 infection and
precancerous lesions of the cervix. Inovio is in open-label Phase 2
clinical trials evaluating its efficacy for treating HPV-related
vulvar and anal precancers. 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 regression of cervical HSIL and clearance of
HPV-16/18 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 DNA
technology targeted against cancers and infectious diseases.
Inovio's proprietary technology platform applies antigen sequencing
and delivery to enable in vivo protein expression, which can
activate potent immune responses to targeted diseases. The
technology 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 development for the treatment of
HPV-related cervical pre-cancer. Also in development are Phase 2
immuno-oncology programs targeting HPV-related cancers and
glioblastoma, as well as externally funded platform development
programs in Zika, MERS, Lassa 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 (CEPI),
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, Medical CBRN Defense Consortium (MCDC),
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 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, 2018, our Quarterly Report on
Form 10-Q for the quarter ended June
30, 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.
CONTACTS:
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|
Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.