Study Results Presented at a Major European
Cancer Conference (ESMO)
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that new
data from the company’s recently completed Phase 1b study with
INO-5150 demonstrated a slowing of Prostate-Specific Antigen
Doubling Time (PSADT) in men with prostate cancer. Eighty six
percent (86%) of patients remained progression-free at Week 72 of
the study. These data were presented in a poster entitled
“Synthetic DNA immunotherapy in Biochemically Relapsed Prostate
Cancer” at the European Society for Medical Oncology (ESMO) 2018
congress in Munich today.
In this study, Inovio evaluated the tolerability
and immunogenicity of INO-5150, a DNA vaccine encoding PSA and
PSMA, with or without INO-9012 (encoding IL-12 immune adjuvant), in
men with biochemically relapsed prostate cancer. The study
demonstrated a slowing of PSA doubling time, a measure of disease
progression, in a majority of patients on the study. In addition,
86% of patients were progression-free at Week 72 of the study,
which in this treatment-refractory, high-risk patient population,
is thought to be clinically promising. Importantly, analyses
demonstrated that immunogenicity was observed in 77% (47/61) of
patients by multiple immunologic assessments.
Previous results from the Phase 1b study were
presented at the 2018 American Society of Clinical Oncology (ASCO)
annual meeting and demonstrated that of the 61 evaluable patients,
77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50)
exhibited CD38+, Perforin+CD8+ T cell responses. Results presented
at ASCO provided clinical data through week 72 and immunology data
through week 27. The latest results being presented at ESMO update
these data and report that 80% of evaluable patients in the trial
demonstrated either INO-5150 specific T cell or antibody
reactivity.
Dr. J. Joseph Kim, Inovio's President and Chief
Executive Officer, said, “The follow-up data and opportunity to
showcase INO-5150 from our Phase 1 prostate cancer study further
helps Inovio’s efforts to enter into a strategic development
partnership to expand into a Phase 2 study. These follow-up results
support the rationale for further development and provides the
basis for a novel checkpoint combination cancer trial.”
This patented approach of INO-5150 in
combination with CELLECTRA® delivery device 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. Moreover, PSMA is also one of 3 antigens comprising
INO-5401, which is being tested in two separate Phase 1/2 trials as
an immunotherapy to treat glioblastoma and metastatic bladder
cancer in combination with Regeneron and Genentech/Roche’s
checkpoint inhibitors, respectively.
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 a late-stage biotechnology company
focused on the discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio’s proprietary immunotherapy platform
technology applies next-generation antigen sequencing and DNA
delivery to activate potent immune responses to targeted diseases.
The technology functions exclusively in vivo, and has been
demonstrated to consistently activate robust and fully functional T
cell and antibody responses against targeted cancers and pathogens.
Inovio is the only immunotherapy company that has reported
generating T cells whose killing capacity correlates with relevant
clinical outcomes. Inovio’s most advanced clinical program,
VGX-3100, is in Phase 3 for the treatment of HPV-related cervical
pre-cancer. 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 Bill & Melinda Gates Foundation, The
Wistar Institute, University of Pennsylvania, the Parker Institute
for Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science,
Plumbline Life Sciences, 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 our plans and expectations regarding
partnerships. 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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