PLYMOUTH MEETING, Pa.,
May 6, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced
that its lead Phase 3 product candidate, VGX-3100, has been granted
an Advanced Therapy Medicinal Product Certificate for quality and
non-clinical data. The procedure of certification of quality and
non-clinical data involves an assessment of the available data in
view of future registration and the related European Scientific
Data Requirements, not including any clinical data or benefit-risk
assessment. The granted EMA's certificate confirms that Inovio's
chemistry, manufacturing and controls (CMC) data and nonclinical
results available to date overall comply with the scientific and
technical standards for evaluating an EU Marketing
Authorization.
Dr. Ami Shah Brown, Inovio's
Senior Vice President of Regulatory Affairs, said, "We are extremely pleased that the current
CMC, coupled with the nonclinical data supporting our lead product,
VGX-3100, meets stringent EMA requirements. This certification is a
testament to Inovio's technical excellence, cross-functional
development expertise, and high quality standards as applied for
VGX-3100 and indirectly for Inovio's technology."
VGX-3100 is currently being tested in a pivotal, global Phase 3
program, which 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. In parallel, the final
commercial manufacturing process will be validated yielding
additional quality data by time of the EU filing.
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 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 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
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, The Wistar Institute, The Bill & Melinda Gates
Foundation, the University of
Pennsylvania, Parker Institute for Cancer Immunotherapy,
CEPI, DARPA, GeneOne Life Science, Plumbline Life Sciences, NIH,
HIV Vaccines Trial Network, National Cancer Institute, Walter Reed
Army Institute of Research, Drexel
University, 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, 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.