PLYMOUTH MEETING, Pa.,
April 1, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
that its Phase 1/2 immuno-oncology trial in patients with newly
diagnosed glioblastoma (GBM) has completed its enrollment three
months ahead of schedule. The 52-patient trial is designed to
evaluate Inovio's INO-5401 T cell activating immunotherapy encoding
multiple antigens expressed by GBM and INO-9012, an immune
activator encoding IL-12, in combination with cemiplimab-rwlc (also
known as Libtayo® or REGN2810), a PD-1 inhibitor
developed by Regeneron Pharmaceuticals in collaboration with
Sanofi. This trial information will be presented today at Phase
I-III Trials in Progress session at the Annual Meeting of the
American Association for Cancer Research being held in Atlanta.
Inovio expects to report interim results from this study before
the end of this year evaluating safety, immunological impact,
progression-free survival and overall survival (see
www.clinicaltrials.gov, identifier NCT03491683).
Dr. J. Joseph Kim, Inovio's
President and Chief Executive Officer, said, "We sincerely thank
the patients and their doctors for participating in our innovative
combination trial. This is an important step for Inovio's cancer
combination strategy using our T cell-generating therapies in
combination with PD-1/PD-L1 inhibitors for GBM and for multiple
other cancers to improve overall efficacy of immunotherapy. We have
previously shown in a Phase 1 head and neck cancer clinical study,
combining Inovio's T cell-generating immunotherapy MEDI0457 along
with checkpoint inhibitors have resulted in two complete responders
who remain cancer free for over two years. In this GBM trial,
our goal is to increase the overall survival of patients facing a
disease where neither the standard of care, nor clinical outcomes
have changed in a clinically significant way in more than a
decade."
Inovio holds clinical partnerships with AstraZeneca for MEDI0457
(in HPV-related cancers) and collaborations with Roche/Genentech
and Regeneron for INO-5401 (in bladder cancer and GBM), each
providing for clinical evaluation of Inovio immunotherapies
combined with checkpoint inhibitors. In particular, the INO-5401
collaborations are based on a strong scientific rationale to
combine two immunotherapies: INO-5401, which generates
antigen-specific killer T cells, and a checkpoint inhibitor, which
augments T cell activity.
About Glioblastoma
Glioblastoma (GBM) is the most common and aggressive type of
brain cancer and remains a devastating disease for both patients
and caregivers. Its prognosis is extremely poor, despite a limited
number of new therapies approved over the last 10 years. The median
overall survival for patients receiving standard of care therapy is
approximately 15 months and the average five-year survival rate is
less than five percent.
About INO-5401
INO-5401 includes Inovio's SynCon® antigens for
hTERT, WT1, and PSMA, and has the potential to be a powerful cancer
immunotherapy in combination with checkpoint inhibitors. The
National Cancer Institute previously highlighted hTERT, WT1, and
PSMA among a list of important cancer antigens, designating them as
high priorities for cancer immunotherapy development. These three
antigens are known to be over-expressed, and often mutated, in a
variety of human cancers, and targeting these antigens may prove
efficacious in the treatment of patients with cancer.
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:
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Investors:
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Ben Matone, Inovio,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.