80% of Methylated Patients and 75% of Unmethylated
Patients Were Disease Progression-Free at 6 Months
PLYMOUTH MEETING, Pa.,
Nov. 5, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
positive interim results from Inovio's Phase 2 study (NCT03491683)
of newly diagnosed glioblastoma multiforme (GBM) combining Inovio's
INO-5401, a T cell-activating immunotherapy encoding for three
tumor-associated antigens (hTERT, WT1, and PSMA), and INO-9012, an
immune activator encoding IL-12, in combination with
Libtayo® (cemiplimab), a PD-1 blocking antibody
developed by Regeneron Pharmaceuticals (NASDAQ: REGN) in
collaboration with Sanofi. The data will be featured in a
late-breaking poster presentation at the Society for Immunotherapy
of Cancer (SITC) 2019 Annual Meeting in National Harbor,
Maryland, November 6-10.
Key interim data from the 52-patient clinical trial showed that
80% (16 of 20) of MGMT gene promoter methylated patients and 75%
(24 of 32) of unmethylated patients were progression-free at six
months (PFS6) measured from the time of their first dose,
substantially exceeding historical standard-of-care data.
This immunotherapy combination with a PD-1 checkpoint inhibitor
also exhibited supportive safety, tolerability, and immunogenicity
data and suggested an acceptable safety profile consistent with
that of Libtayo and Inovio's platform technology. The majority of
patients tested had a T cell immune response to one or more
tumor-associated antigens encoded by INO-5401. Immune responses to
all three tumor-associated antigens were demonstrated in this
study. Inovio plans to report 12- and 18-month overall survival
data next year.
Dr. David Reardon, M.D.,
Coordinating Principal Investigator of the study and the Clinical
Director for Neuro-Oncology at the Dana-Farber Cancer Institute,
said, "This innovative trial provides promising information that
the combination of INO-5401 plus INO-9012, a T cell-promoting
therapy, combined with Libtayo, a checkpoint inhibitor, may provide
clinically meaningful benefit in this very difficult to treat
disease."
Dr. J. Joseph Kim, Inovio's
President & CEO, said, "Our new data demonstrates the potential
of our immunotherapies utilizing tumor-associated antigens in
cancer treatments. Our goal in this GBM trial is to increase
progression-free and overall survival of patients facing a disease
where neither the standard of care nor clinical outcomes have
significantly advanced in decades. Previously, other checkpoint
inhibitor treatment alone in GBM trials did not show any meaningful
clinical benefit over standard of care. However, the addition of
INO-5401 and its ability to generate antigen-specific T cells
demonstrated early efficacy signals in progression-free survival.
We look forward to reporting additional data including overall
survival at months 12 and 18 from the trial in the coming
year."
Poster Details
Poster 858:
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An Open-Label,
Multi-center Trial of INO-5401 and INO-9012 Delivered by
Electroporation (EP) in Combination with Cemiplimab in Subjects
with Newly-Diagnosed Glioblastoma (GBM)
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Category:
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Late-Breaker
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Date/Time:
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Friday, Nov.
8th, 12:30 – 2 p.m. and Saturday, Nov. 9th
12:35 – 2:05 p.m.
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Location:
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Displayed in the
Potomac Foyer (outside the Plenary session room, Potomac
Ballroom)
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Study Design
The trial was designed to evaluate safety, immunogenicity and
preliminary efficacy of INO-5401 and INO-9012 in combination with
Libtayo, with radiation and chemotherapy, in subjects with
newly-diagnosed glioblastoma (GBM). This is a Phase 1/2,
open-label, multi-center trial conducted in 52 evaluable patients
with GBM. There were 2 cohorts in this trial. Cohort A were
participants with a tumor with an unmethylated
O6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase
(MGMT) promoter. Cohort B included participants with a tumor with a
MGMT methylated promoter or who have indeterminate MGMT status.
Both cohorts received INO-5401 and INO-9012 and Libtayo at the same
doses and on the same dosing schedule, and both cohorts received
radiation and temozolomide (TMZ), if clinically indicated. Interim
data presented here and at SITC was obtained as of October 2019 and final study data is expected in
Q4 2020. For more information of the clinical study, see
www.clinicaltrials.gov, identifier NCT03491683.
About Glioblastoma Multiforme (GBM)
GBM is the most common and aggressive type of brain cancer and
remains a devastating disease for both patients and caregivers. Its
prognosis is extremely poor, despite a limited number of new
therapies approved over the last 10 years. The median overall
survival for patients receiving standard of care therapy is
approximately 15 months and the median progression-free survival is
approximately 7 months. In the U.S., the estimated annual incidence
of GBM is 11,362 cases or 3.21 cases per 100,000 persons and the
median age at diagnosis is 65 years.
About INO-5401 and INO-9012
INO-5401 encodes for 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 were reported 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. INO-9012
encodes for IL-12, which is a T cell immune activator.
About Inovio Pharmaceuticals, Inc.
Inovio is an innovative biotechnology company focused on the
discovery, development, and commercialization of its synthetic DNA
technology targeted against cancers and infectious diseases.
Inovio's proprietary technology platform applies antigen sequencing
and delivery to enable in vivo protein expression, which can
activate potent immune responses to targeted diseases. The
technology has been demonstrated to consistently activate robust
and fully functional T cell and antibody responses against targeted
cancers and pathogens. Inovio's most advanced clinical program,
VGX-3100, is in Phase 3 development for the treatment of
HPV-related cervical pre-cancer. Also in development are Phase 2
immuno-oncology programs targeting HPV-related cancers and GBM, as
well as externally funded platform development programs in Zika,
MERS, Lassa, and HIV. Partners and collaborators include ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations (CEPI), Defense
Advanced Research Projects Agency, GeneOne Life Science, HIV
Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC),
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, , Regeneron,
Roche/Genentech, the University of
Pennsylvania, Walter Reed Army Institute of Research and The
Wistar Institute. For more information, visit www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA-based immunotherapies, 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. 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, 2018, our Quarterly Report on Form
10-Q for the quarter ended June 30,
2019, and other filings we make from time to time with the
Securities and Exchange Commission. 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 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:
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Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.