Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced
initiation of a phase 1b/2 immuno-oncology trial to evaluate
Genentech/Roche’s atezolizumab (TECENTRIQ®) in combination with
Inovio’s INO-5401, a T cell activating immunotherapy encoding
multiple antigens, and INO-9012, an immune activator encoding
IL-12.
The multi-center, open-label efficacy trial will
be managed by Inovio, and Genentech will supply atezolizumab. The
trial will evaluate the safety, immune response and clinical
efficacy of the combination therapy in approximately 80 patients
with advanced bladder cancer, specifically advanced unresectable or
metastatic urothelial carcinoma (UC), the most common type of
bladder cancer. The majority of the patients to be enrolled in the
trial will have previously received and failed to demonstrate
meaningful response to an anti-PD-1 or PD-L1 checkpoint inhibitor
alone. Thus the study will evaluate potential benefit of a
checkpoint inhibitor combined with a DNA-based immunotherapeutic
and T cell activator within a bladder cancer patient population
with very limited treatment options and poor outcomes. The
immunologic analyses accompanying the study will provide further
insight into mechanisms of checkpoint inhibition and T cell
activation in bladder cancer.
Dr. Joaquim Bellmunt, MD, PhD, Director of
Bladder Cancer Center, Dana-Farber Cancer Institute and Associate
Professor, Harvard Medical School, said, “The unmet need for
effective treatments for advanced UC patients remains very high
even in the midst of approvals of multiple checkpoint inhibitors in
this space -- as only a small subset of patients respond to these
therapies alone. Increasing evidence suggests that combinatorial
approaches are needed to improve upon the initial success of
checkpoint inhibitors; the benefit to this patient population may
be significantly improved when combination therapies that also
generate activated T cells are utilized. Furthermore, there is a
very high need for effective treatment approaches in
checkpoint-refractory patients.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, “Combining INO-5401 with TECENTRIQ may provide a synergistic
therapeutic effect as a result of generating high levels of
activated T cells and simultaneously inhibiting PD-L1. Bladder
cancer has often been described as an immunogenic tumor, and here
our approach is to augment the anti-PD-1/PD-L1 driven efficacy by
further enhancing the T cells against the tumor in a cancer
antigen-specific manner. We believe we can demonstrate the immense
potential of INO-5401 as a universal cancer immunotherapy to treat
patients with multiple cancers.”
Nearly 430,000 new cases of urinary bladder
cancer are diagnosed each year worldwide; it accounts for about
165,000 deaths worldwide annually. Advanced unresectable or
metastatic UC remains a high unmet medical need as survival remains
poor for most patients who experience disease progression or
intolerance to treatment during or after platinum-containing
chemotherapy. The approval of several checkpoint inhibitors for
advanced unresectable or metastatic UC has improved response and
survival rates for some patients, however, the majority of patients
do not experience meaningful clinical responses to checkpoint
inhibitor monotherapy.
Inovio’s INO-5401, an immunotherapy encoding
multiple cancer antigens (HTERT, PSMA, and WT1), is designed to
generate and activate T cells to many cancer types including
bladder cancer. INO-9012, a DNA-based immune activator encoding
IL-12, is designed to amplify and accelerate T cell immune
responses to INO-5401. Combining INO-5401/INO-9012 with
atezolizumab may provide a synergistic therapeutic effect as a
result of generating higher levels of activated T cells and
simultaneously inhibiting PD-L1. Atezolizumab is a monoclonal
antibody designed to bind with a protein called PD-L1 expressed on
tumor cells and tumor-infiltrating immune cells, blocking its
interactions with both PD-1 and B7.1 receptors. By inhibiting
PD-L1, atezolizumab may enable the activation of T cells.
About Metastatic Urothelial Carcinoma
(UC)
The prognosis for patients with advanced
unresectable or metastatic UC is poor, with limited treatment
options. It is a disease that has seen no major advances for more
than 30 years until the approvals of checkpoint inhibitors.
Expected survival is generally less than 12 months; in the U.S.,
five-year survival of patients with distant metastasis is 5%. In
the US, an estimated 79,000 new cases of urinary bladder cancer are
expected in 2017.
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 and placing
WT1 at the top of the antigen list. The hTERT antigen is expressed
in 85% of cancers; the WT1 and PSMA antigens are also widely
prevalent in many cancers. In addition, INO-5401 is being evaluated
for the treatment of GBM in combination with a checkpoint
inhibitor.
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, Regeneron, Genentech/Roche, 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.
TECENTRIQ® (atezolizumab) is a registered
trademark of Genentech, a member of the Roche Group.
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, 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. Forward-looking statements speak only as of the date of
this release, and Inovio undertakes no obligation to update or
revise these statements, except as may be required by law.
CONTACTS:
Investors/Media: Jeff Richardson, Inovio Pharmaceuticals,
267-440-4211, jrichardson@inovio.com
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