OncoSec Medical Plans to Initiate Pilot Study in Triple Negative Breast Cancer
January 12 2015 - 6:02AM
Business Wire
Study to Be Conducted at Stanford
University
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, plans to initiate a
pilot study to assess IL-12 ImmunoPulse in patients with Triple
Negative Breast Cancer (TNBC). The study will be conducted at
Stanford University with Melinda L. Telli, MD, serving as lead
investigator.
This pilot study is designed to assess whether IL-12 ImmunoPulse
increases TNBC tumor immunogenicity by driving a pro-inflammatory
cascade of events that leads to increases in cytotoxic
tumor-infiltrating lymphocytes (TILs). The presence and number of
TILs is thought to be a key requirement for promoting the
anti-tumor activity of antibodies like anti-PD-1/PD-L1. By driving
cytotoxic immune cells into the tumor, IL-12 ImmunoPulse may be an
ideal candidate to combine with checkpoint blockade therapies which
reported some activity in TNBC.
Worldwide, TNBC amounts to approximately 200,000 cases each year
and accounts for approximately 20 percent of all breast cancer. It
is most commonly diagnosed in younger women (less than 40 years)
and is characterized by higher relapse rates when compared with
estrogen receptor (ER)-positive breast cancers. TNBC is also
associated with an increased risk of recurrence, both locally and
in distant sites, including the lung and brain. Advanced TNBC
remains a significant area of unmet medical need and there is no
established standard-of-care. Treatment generally includes
chemotherapy, with or without radiation and/or surgery. However, no
treatment regimen has clearly demonstrated superiority.
Previous studies have reported that patients with TNBC tumors
associated with markers of inflammation, such as the presence of
tumor-infiltrating lymphocytes (TILs), have improved survival, and
recent data presented have shown that TNBC is responsive to
immunotherapies like anti-PD-1 or anti-PD-L1 checkpoint blockade
drugs. Response rates in TNBC patients receiving either anti-PD-1
or anti-PD-L1 in early Phase 1 studies were reported to be 18 to 33
percent.
“The data presented at the 2014 San Antonio Breast Cancer
Symposium (SABCS), combined with historical data correlating
increased immunogenicity with improved survival in TNBC, strongly
suggest that treatments aimed at augmenting pro-inflammatory
signals within the tumor have a central role in improving the
clinical outcomes for TNBC patients,” said Mai H. Le, Chief Medical
Officer at OncoSec Inc. “We are very excited to be working closely
with our colleagues at Stanford on this pilot clinical program,
which is specifically designed to evaluate the role of IL-12
ImmunoPulse in promoting tumor immunogenicity in TNBC and,
ultimately, improving patient outcomes.”
Dr. Robert H. Pierce, OncoSec’s Chief Scientific Officer,
commented: “Both the Merck and Roche/Genentech studies presented at
SABCS indicate that a distinct sub-population of TNBC patients
respond to inhibition of the immunosuppressive PD-1/PD-L1 axis.
Both independent studies support the emerging paradigm that the
presence of ‘stalled’ CD8 T cells (so called ‘adaptive resistance’)
drives the response to PD-1/PD-L1 therapeutics. We are excited that
two experts in this field, Drs. Holbrook Kohrt (Stanford) and Paul
Tumeh (UCLA), will be involved in analyzing our samples from this
pilot study.”
About OncoSec Medical
OncoSec Medical Inc. is a biopharmaceutical company developing
its investigational ImmunoPulse intratumoral cancer immunotherapy.
OncoSec Medical's core technology is designed to
enhance the local delivery and uptake of DNA IL-12 and
other DNA-based immune-targeting agents. Clinical studies of
ImmunoPulse have demonstrated an acceptable safety profile and
preliminary evidence of anti-tumor activity in the treatment of
various skin cancers, as well as the potential to initiate a
systemic immune response without the systemic toxicities associated
with other treatments. OncoSec's lead program evaluating
ImmunoPulse for the treatment of metastatic melanoma is currently
in Phase 2 development, and is being conducted in collaboration
with several prominent academic medical centers. As the company
continues to evaluate ImmunoPulse in its current indications, it is
also focused on identifying and developing new immune-targeting
agents, investigating additional tumor indications, and evaluating
combination-based immunotherapy approaches. For more information,
please visit www.oncosec.com.
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements are based on management’s current
preliminary expectations and are subject to risks and
uncertainties, which may cause our results to differ materially and
adversely from the statements contained herein. Some of the
potential risks and uncertainties that could cause actual results
to differ from those predicted include our ability to raise
additional funding, our ability to acquire, develop or
commercialize new products, uncertainties inherent in pre-clinical
studies and clinical trials, unexpected new data, safety and
technical issues, competition, and market conditions. These and
additional risks and uncertainties are more fully described in
OncoSec Medical’s filings with the Securities and Exchange
Commission. Undue reliance should not be placed on forward-looking
statements, which speak only as of the date they are made. OncoSec
Medical disclaims any obligation to update any forward-looking
statements to reflect new information, events or circumstances
after the date they are made, or to reflect the occurrence of
unanticipated events.
Investor Relations:OncoSec Medical Inc.Jordyn Kopin,
855-662-6732investors@oncosec.comorPublic Relations:Dian Griesel
Int’l.Laura Radocaj, 212-825-3210lradocaj@dgicomm.com
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