Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has dosed its first patient as part of its Phase 1/2
immuno-oncology trial in patients with newly diagnosed glioblastoma
(GBM). The efficacy 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 (REGN2810), a PD-1 inhibitor
developed by Regeneron Pharmaceuticals.
Dr. J. Joseph Kim, Inovio's President and Chief
Executive Officer, said, “GBM is a devastating cancer, and
malignant glioma has already claimed the lives of Senator Ted
Kennedy and Beau Biden, the son of the former Vice President Joe
Biden. GBM is also the cancer that Senator John McCain and
thousands of other patients are battling every year. We are proud
to have treated our first patient with a powerful combination of
Inovio’s T cell-generating immunotherapy INO-5401 with Regeneron’s
PD-1 checkpoint inhibitor this week. This is an important step for
Inovio’s plan to use its T cell-generating therapies in combination
with PD-1/PD-L1 inhibitors for GBM and for multiple other cancers
to improve overall efficacy. In preclinical studies,
combination of Inovio’s T cell-generating immunotherapies along
with checkpoint inhibitors have shown to shrink tumors and improve
overall survival of tumor-bearing animals. 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 not changed in a clinically significant way in more than a
decade.”
Dr. David Reardon, Associate Professor,
Medicine, Harvard Medical School and Clinical Director, Center for
Neuro-Oncology, Medical Oncology, Dana-Farber Cancer Institute and
the trial’s coordinating principal investigator, said, “The Inovio
vaccine platform is highly innovative and uniquely designed with
the potential to generate robust anti-tumor immune responses. We
are very hopeful that this novel vaccine technology will translate
into meaningful therapeutic benefit when integrated with standard
radiation and temozolomide chemotherapy combined with anti-PD-1
treatment for newly diagnosed glioblastoma patients in our recently
initiated trial.”
Inovio holds clinical partnerships with
MedImmune for INO-3112 (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.
The open-label trial of 50 newly diagnosed GBM
patients will be conducted at approximately 25 U.S. sites, and the
primary endpoint is safety and tolerability. The study will also
evaluate immunological impact, progression-free survival and
overall survival.
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
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio’s proprietary platform technology,
ASPIRE, 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
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. 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 head
and neck cancer, 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 Wistar Institute,
University of Pennsylvania, the 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, our plans and expectations regarding
partnerships and the plans of GENEOS Therapeutics, Inc. to raise
capital. 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 March 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, Inovio, 484-362-0076,
ben.matone@inovio.comMedia: Jeff Richardson, Inovio, 267-440-4211,
jrichardson@inovio.com
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