PLYMOUTH MEETING, Pa.,
June 26, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced
the completion of target enrollment of 198 participants for its
pivotal Phase 3 registration trial ("REVEAL 1") of VGX-3100, a
novel DNA-based immunotherapy being tested to treat cervical
dysplasia caused by human papillomavirus (HPV). Left untreated,
cervical dysplasia can progress to cervical cancer. If approved,
VGX-3100 would be the first immunotherapy and non-surgical
alternative for women with late-stage cervical dysplasia.
Dr. J. Joseph Kim, Inovio's
President & CEO, said, "This establishes an important milestone
for the company as it brings Inovio another step closer to
providing an innovative treatment alternative to the women
suffering with cervical dysplasia for whom surgery is the only
option today. Both the U.S. and Europe represent large markets in need of a
non-invasive treatment option for women, and we're now focused on
enrolling the confirmatory study (REVEAL 2) to generate a U.S. FDA
submission in 2021."
Inovio's Phase 3 program is assessing the efficacy of VGX-3100
to regress cervical HSIL (high-grade squamous intraepithelial
lesions), a direct precursor to cervical cancer, and to eliminate
the HPV infection that causes these lesions. 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. REVEAL 1 is designed to provide a one-year
safety data for a minimum of 198 patients on VGX-3100. A
confirmatory Phase 3 trial (REVEAL 2) is currently enrolling and is
designed to provide a one-month safety data for a minimum of 198
patients.
The primary endpoint of the Phase 3 study 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.
Dr. Prakash Bhuyan, MD PhD,
Clinical Development lead for VGX-3100, said, "The completion of
REVEAL 1 enrollment is a testament to the dedication of our
outstanding investigators and their teams, who span 19 countries –
a true global effort – to develop a non-surgical treatment for
cervical high-grade dysplasia."
As previously announced in March of 2019, Inovio has also begun
recruitment for the confirmatory Phase 3 trial REVEAL 2 in
March 2019. Following the completion
of enrollment announcement for REVEAL 1, REVEAL 2 will now be
enrolling from all sites both within the U.S. and globally,
including sites that that were utilized in REVEAL 1.
Inovio previously reported that VGX-3100 eliminated high grade
dysplasia in almost 50% of women in its Phase 2b randomized, placebo-controlled trial. In 80%
of the women whose high grade dysplasia was eliminated, the HPV
infection was also cleared by VGX-3100. Further data analysis
revealed that the combination of HPV detection and cervical
cytology (Pap smear) following dosing was predictive early during
the treatment period for both elimination of the high grade
dysplasia and clearance of HPV.
In addition, Inovio continues to pursue development of
pre-treatment biomarker tests in collaboration with QIAGEN that may
provide the ability to predict clinical response to VGX-3100,
ultimately aiding in patient selection and physician guidance of
patient care. These pre-treatment biomarkers could identify
patients most likely to respond to treatment with VGX-3100,
increasing absolute efficacy of the product.
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 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 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 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.
Contact:
|
|
Investors
|
Media
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Ben Matone
|
Jeffrey C.
Richardson
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1-484-362-0076
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1-267-440-4211
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ben.matone@inovio.com
|
jrichardson@inovio.com
|
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SOURCE Inovio Pharmaceuticals, Inc.