Inovio Pharmaceuticals, Inc. (NASDAQ:INO), today announced that an
interim data analysis showed that its INO-5150 cancer immunotherapy
product generated antigen-specific CD8+ killer T cell responses
measured in peripheral blood from subjects with biochemically
recurrent prostate cancer. The immunology results demonstrate that
INO-5150 treatment as a monotherapy generated prostate specific
antigen (PSA) and prostate specific membrane antigen (PSMA)
specific T cell responses in peripheral blood in 60% (35/58) of the
subjects. Moreover, patients with specific CD8+ T cell responses
experienced dampening in the rise of PSA and significant increases
in PSA Doubling Times (PSADT). PSA is a prostate cancer associated
biomarker and positive changes on PSA levels could signal
INO-5150’s potential positive impact on the treatment of prostate
cancer.
These results were presented as a poster
discussion on September 10th at the 2017 European Society of
Medical Oncology (ESMO) meeting in Madrid, Spain.
Dr. Neil Shore, MD, Medical Oncologist at
Urologic Associates of North Carolina, and the principal
investigator of this study said, “Immunotherapy is an exciting new
approach being evaluated for the treatment of many cancers
including prostate cancer, where a small subset of patients have
been shown to demonstrate clinical benefit from such therapy in the
form of checkpoint inhibitors. Our study provides encouraging
immunologic and clinical data that Inovio’s immunotherapy product
can generate antigen-specific CD8+ killer T cell responses in the
blood and link such responses to PSA changes in prostate cancer
patients. Our results suggest that further evaluation of this
product in prostate cancer patients should be explored.”
Dr. J. Joseph Kim, Inovio's President and CEO,
said, "As a leader in active immunotherapy for cancer with its lead
program in phase 3, Inovio is pleased to report on promising phase
1b clinical trial data of our prostate cancer therapy INO-5150. The
immunotherapy’s ability to generate anti-prostate cancer CD8+ T
cell responses in patients dosed is truly exciting. Perhaps even
more importantly, we also observed that the treated patients with
better T cell responses saw a slower rise of PSA levels compared to
those without the T cell responses.
We believe the new clinical data positions
INO-5150 as an attractive T cell generating immunotherapy component
of a potential combination regimen. In this regard, Inovio already
has one the most extensive and dynamic T cell immunotherapy combo
portfolio in our field, with three different PD-1/PDL-1
immuno-oncology combo efficacy studies with 3 different
collaborators – MedImmune, Regeneron, and Genentech for MEDI0457
and INO-5401.”
INO-5150, an active immunotherapy targeting both
PSA and PSMA antigens which are present in the majority of prostate
cancer cells, is administered with and without INO-9012, Inovio’s
DNA-based IL-12 immune activator. INO-5150 is designed to activate
patients’ immune responses and to specifically target prostate
cancers expressing PSA and PSMA. This open label phase 1b study has
fully enrolled 62 subjects with biochemically recurrent (rising
PSA) prostate cancer and is intended to assess the safety,
tolerability, dosing and immunogenicity of INO-5150 alone or in
combination with INO-9012. This multi-centered study is also
evaluating changes in PSA levels and kinetics, as PSA is an
important biomarker in prostate cancer.
INO-5150 was generated using Inovio's
proprietary technology process to enable significant production of
PSA and PSMA antigens with genetic sequences differentiated from
native human PSA and PSMA sequences. This patented approach is
designed to help the body's immune system overcome its
"self-tolerance" to prostate cancer cells and mount a strong
targeted CD8+ killer T cell response to eliminate the cancerous
cells displaying these antigens. PSMA is also one of 3 antigens
comprising INO-5401, which is being tested as an immunotherapy to
treat glioblastoma multiforme and metastatic bladder cancer in
combination with Regeneron and Genentech’s checkpoint inhibitors,
respectively.
This poster presentation provided immune
response and clinical correlation across all four cohorts. In
addition to immune responses, clinical correlative analyses
evaluating PSA kinetics showed that patients with specific CD8+ T
cell responses experienced dampening in the rise of PSA and
significant increases in PSADT. Additional prostate cancer tissue
analyses are ongoing to further investigate immunological
correlation.
About Prostate Cancer and Biochemically
Recurrent Prostate Cancer (BRPC)
Prostate cancer is the second most frequently
diagnosed cancer in men. Nearly three-quarters of the registered
cases occur in developed countries. Accounting for nearly 300,000
deaths each year, prostate cancer is the sixth leading cause of
death from cancer in men. There are about 60,000 patients each year
in the US that develop biochemically recurrent prostate cancer
(BRPC). The development of a new treatment for prostate cancer
would be a significant medical advance given that current
standard-of-care treatment options (surgery, radiation and hormone
deprivation), while somewhat effective, all carry deleterious side
effects and are often not a long-term cure.
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, 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 development of
INO-5150, and,INO-9012, 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 contribute expected resources and products,
and certain 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.
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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