Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced a
clinical collaboration with Genentech, a member of the Roche Group,
for advanced bladder cancer. The phase 1b/2 immuno-oncology trial
will evaluate Genentech’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 trial will be
managed by Inovio, and Genentech will supply atezolizumab. It is
anticipated to start in 2017 and designed to 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 a 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.
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, is designed to generate and activate
T-cells to many cancer types including bladder cancer. INO-9012, an
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.
Dr. Joaquim Bellmunt, MD, PhD,
Dana-Farber/Brigham and Women's Cancer Center Associate Professor,
Harvard Medical School, said, “Urothelial carcinoma represents an
area of high unmet need. Checkpoint inhibitors offer significant
potential, however, only a proportion of patients respond to these
therapies alone. Increasing evidence suggests that combinatorial
approaches are needed and a combination of a checkpoint inhibitor
with an immunotherapy that generates antigen-specific T cells may
offer the potential for significantly increased benefit.”
Dr. J. Joseph Kim, Inovio's President and Chief
Executive Officer, said, “We are excited to collaborate with
Genentech, a leader in the development of transformative products
to treat cancer. I am a strong believer in combination
immuno-oncology regimens employing an immunotherapy to generate
significant antigen-specific killer T cells then blocking T cell
suppression via checkpoint inhibition. We believe INO-5401 has
significant potential as a cancer immunotherapeutic in combination
with a checkpoint inhibitor to address the high unmet medical need
for advanced bladder cancer patients and to provide meaningful
benefit for checkpoint inhibitor refractory patients.”
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, 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 and 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, including the cancer immunotherapy INO-5401,
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 broad 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,
Form 10-Q for the quarter ended March 31, 2017, and other
regulatory filings from time to time. There can be no assurance
that any product in Inovio's pipeline will be successfully
developed or manufactured, that final results of clinical studies
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.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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