Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that it
has dosed its first patient in a Phase 1/2a study designed to
evaluate the safety, immunogenicity and clinical efficacy of
INO-5401, Inovio’s novel cancer immunotherapy that encodes multiple
cancer antigens, plus INO-9012, a T cell activator, in combination
with atezolizumab, (F. Hoffman-La Roche Ltd.) a PD-L1 inhibitor,
for the treatment of advanced or metastatic bladder cancer. The
trial, which is being managed by Inovio, is expected to enroll
approximately 85 patients at sites located in the United
States and Spain.
Dr. J. Joseph Kim, Inovio's President and Chief
Executive Officer, said, “We are very encouraged to dose our first
patient with the aspiration that we can demonstrate the immense
potential of our INO-5401 immunotherapy to treat advanced bladder
patients as well as those with other cancers. This also marks the
second time in less than a month that Inovio has dosed a cancer
patient, combining INO-5401, our T cell-generating immunotherapy
with a checkpoint inhibitor. Bladder cancer is considered an
immunogenic tumor and our approach is to combine INO-5401/INO-9012
with atezolizumab as we believe this may provide a synergistic
therapeutic effect by generating functional and activated T cells
while simultaneously inhibiting PD-L1. We remain on track and look
forward to producing interim clinical results in 2019.”
This open-label, multi-center Phase 1/2a study
plans to enroll 85 patients divided into two cohorts. Cohort A
includes patients with confirmed disease progression during or
following prior checkpoint inhibitor therapy, while Cohort B
patients are treatment naïve and unfit for cisplatin-based therapy.
Primary endpoints are incidence of AEs, antigen-specific
immunologic activation and objective response rate (ORR) in Cohort
A. Secondary endpoints are Cohort B’s ORR, duration of response,
progression free survival and overall survival. Exploratory
endpoints are correlation of biomarkers to anti-tumor activity. A
safety run-in will be performed for the first six patients enrolled
in Cohort A to monitor emergence of any dose limiting toxicities.
INO-5401 and INO-9012 (10 mg DNA combined in 1ml) will be
administered by intramuscular injection followed by electroporation
every 3 weeks for first 4 doses, every 6 weeks for 6 doses and
every 12 weeks until disease progression. Atezolizumab (1200 mg IV)
will be administered every 3 weeks until disease progression. Tumor
imaging, disease assessment (per RECIST and iRECIST) and biopsies,
blood and urine samples will be collected at set time points
including prior to study treatment, on treatment and at disease
progression (see www.clinicaltrials.gov, identifier
NCT03502785).
About Advanced Bladder Cancer
The prognosis for patients with advanced
unresectable or metastatic bladder cancer 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 U.S., an estimated 81,190 new cases of bladder cancer
are expected in 2018.
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. The Inovio technology platform is
designed to activate an individual’s immune system to generate a
robust, targeted T cell and antibody response against targeted
diseases. Inovio is the only immunotherapy company that has
reported generating T cells entirely in vivo in high quantity
that are fully functional and whose killing capacity correlates
with relevant clinical outcomes with a favorable safety profile.
Inovio’s most advanced clinical program, VGX-3100, is in Phase 3
for the treatment of HPV-related cervical precancer. 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, DARPA, GeneOne Life Science, Plumbline Life
Sciences, Drexel University, National Institute of Allergy and
Infectious Diseases, U.S. Army Medical Research Institute of
Infectious Diseases, NIH, HIV Vaccines Trial Network, U.S. Military
HIV Research Program and CEPI. 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,
as well as our plans and expectations regarding the presentation of
data at scientific conferences. 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 June 30, 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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