Inovio Pharmaceuticals Initiates Immuno-Oncology Clinical Study for Glioblastoma in Combination with Regeneron’s PD-1 Inhi...
November 01 2017 - 8:18AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today initiated a phase
1b/2a immuno-oncology trial in patients with newly diagnosed
glioblastoma (GBM) designed to evaluate cemiplimab (also known as
REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals,
Inc. (NASDAQ:REGN), in combination with Inovio’s INO-5401 T cell
activating immunotherapy encoding multiple antigens and INO-9012,
an immune activator encoding IL-12.
The open-label trial of 50 patients will be
conducted at approximately 30 U.S. sites, and the primary endpoints
are safety and tolerability. The study will also evaluate
immunological impact, progression-free survival and overall
survival.
GBM is a devastating disease for both patients
and caregivers. It is the most aggressive brain cancer and 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 three percent.
Dr. J. Joseph Kim, Inovio's President and Chief
Executive Officer, said, “Inovio is successfully executing on its
immuno-oncology strategy through both combination and in
monotherapy trials. Our clinical partnerships and collaborations
with MedImmune, Genentech and Regeneron each provide for clinical
evaluation of Inovio immunotherapies combined with checkpoint
inhibitors, given a strong scientific rationale to combine an
immunotherapy, which generates antigen-specific killer T cells,
with a checkpoint inhibitor which augments T cell activity. I
believe that INO-5401, a three antigen product targeting WT-1, PSMA
and hTERT, offers great potential to address multiple
cancers. Our INO-5401 combination study in GBM, as well as
its sister study in advanced bladder cancer, represents an
important opportunity for Inovio and its collaborators to address
significant unmet medical need.”
Under a May 2017 agreement between Inovio and
Regeneron, the combination trial will be solely conducted and
funded by Inovio, based upon a mutually agreed upon trial design,
and Regeneron will supply cemiplimab. Inovio and Regeneron will
jointly conduct immunological analyses in support of the study.
Regeneron, as part of their immuno-oncology collaboration with
Sanofi, is developing cemiplimab both as a monotherapy and in
combination with other therapies for the treatment of various
cancers.
About Glioblastoma
Glioblastoma, also known as glioblastoma
multiforme (GBM), is the most common and aggressive type of brain
cancer. GBM is usually found in the area of the brain which
controls some of the most advanced processes, such as speech and
emotions. GBM treatment is often limited by the tumor location and
ability of a patient to tolerate surgery. Consequently, it is a
particularly difficult cancer to treat. Worldwide there are an
estimated 240,000 cases of brain and nervous system tumors per
year; GBM is the most common and most lethal of these tumors.
About INO-5401
INO-5401 includes Inovio’s SynCon® antigens for
WT1, hTERT and PSMA and has the potential to be a powerful cancer
immunotherapy in combination with checkpoint inhibitors. The
National Cancer Institute previously highlighted WT1, hTERT and
PSMA among a list of attractive cancer antigens, designating them
as high priorities for cancer immunotherapy development. WT1 was at
the top of the list. The hTERT antigen relates to 85 percent of
cancers, and WT1 and PSMA antigens are also widely prevalent in
many cancers.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, ApolloBio
Corporation, 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, and the sufficiency of our capital
resources. 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 including
INO-5401 and INO-9012, 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
the company or its collaborators, including alternatives that may
be more efficacious or cost effective than any therapy or treatment
that the company and its collaborators hope to develop, issues
involving product liability, issues involving patents and whether
they or licenses to them will provide the company 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 the company can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
the company's 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, 2016,
our Form 10-Q for the period ended June 30, 2017, and other
regulatory filings we make from time to time. There can be no
assurance that any product candidate in Inovio's 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. In addition, the forward-looking statements included in
this press release represent Inovio’s views as of the date hereof.
Inovio anticipates that subsequent events and developments may
cause its views to change. However, while Inovio may elect to
update these forward-looking statements at some point in the
future, the company specifically disclaims any obligation to do so,
except as may be required by law. These forward-looking statements
should not be relied upon as representing Inovio’s views as of any
date subsequent to the date of this release.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals,
267-440-4211, jrichardson@inovio.com
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