PLYMOUTH MEETING, Pa.,
March 4, 2019 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ: INO) today announced the initiation
and opening of sites to enroll the second portion of the company's
Phase 3 program for VGX-3100, Inovio's DNA-based immunotherapy to
treat cervical dysplasia caused by human papillomavirus (HPV). The
study, named REVEAL 2, is the company's confirmatory stage Phase 3
clinical study and is designed to evaluate the efficacy and safety
of VGX-3100. If approved after completion of the Phase 3 clinical
trials, VGX-3100 will stand as the first immunotherapy for women
with cervical dysplasia. The company made the announcement in
concert with the celebration marking the 2019 International HPV
Awareness Day. The annual campaign encourages everyone to
take action to learn about HPV, and how to manage the risk of HPV
related cancers and precancers. (For more information on HPV Day
visit: https://www.askabouthpv.org/)
Dr. J. Joseph Kim, Inovio's
President & CEO, said, "The early initiation of our REVEAL 2,
our second Phase 3 study, marks another milestone for our lead
product VGX-3100. I am confident in our team's experience and
expertise to advance the REVEAL program forward to deliver on our
goal to file a BLA for VGX-3100 in 2021. And most importantly, we
remember that patients are waiting and our efforts are bringing an
innovative, impactful therapy to people where surgery is their only
option.
Dr. Kim added, "Inovio is also investigating VGX-3100 in Phase 2
clinical trials for treating anal and vulvar dysplasia with interim
results expected later this year."
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.
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.
For more information on these studies, please visit
clinicaltrials.gov (search identifier NCT03185013 and NCT03721978
for REVEAL 1 and REVEAL 2, respectively).
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 for both
elimination of the high grade dysplasia and clearance of HPV.
In addition to advancing its HPV program trial enrollment,
Inovio continues to pursue research into biomarkers with the intent
of attaining the ability to predict clinical response to VGX-3100
that may ultimately aid 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 a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA-based
immunotherapies and vaccines that transform the treatment and
prevention of cancer and infectious disease. Inovio's proprietary
technology platform applies next-generation antigen sequencing and
DNA 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 precancer.
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 MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Bill and Melinda Gates
Foundation, The Wistar Institute, the University of Pennsylvania, Parker Institute for
Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline
Life Sciences, 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, 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, 2017, our Quarterly Report on Form
10-Q for the quarter ended September 30,
2018 and other regulatory filings we make from time to
time. 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 licensed
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:
Investors:
Ben Matone, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.