SAN DIEGO, June 16, 2015 /PRNewswire/ -- OncoSec Medical
Inc. ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based
intratumoral cancer immunotherapies, announced today that the
company has enrolled the first patient into OMS-I130, a Phase II
clinical trial of ImmunoPulse™ IL-12 in patients with
treatment-refractory, metastatic and unresectable squamous cell
carcinoma of the head and neck (HNSCC). ImmunoPulse™ IL-12, which
employs intratumoral electroporation to enhance delivery of
DNA-based interleukin-12 (IL-12), is designed to promote an
anti-tumor immune response.
"This study will address one of the great unmet medical needs in
oncology today: the number of patients who do not respond to
anti-PD-1 treatment," said Mai H.
Le, MD, Chief Medical Officer of OncoSec. "As we expand the
application of ImmunoPulse™ IL-12 beyond cutaneous cancer
indications, we anticipate that it will augment the anti-tumor
immune response in HNSCC and increase the number of patients who
will respond to anti-PD-1 therapy."
Robert H. Pierce, MD, Chief
Scientific Officer of Oncosec and a member of the anti-PD-1
Biomarker Team while at Merck, added, "Key biomarker data was
recently presented at the 2015 American Society of Clinical
Oncology (ASCO) annual meeting, showing that a specific
NanoString®-based gene expression profile characterizes
anti-PD-1 response in HNSCC. Importantly, at OncoSec, we have
observed the ability of ImmunoPulse™ IL-12 to promote this
NanoString® gene expression signature in melanoma, and
we anticipate that this will be observed in HNSCC as well."
The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and lead author of the
presentation outlining the key gene signature for anti-PD-1
responders with HNSCC, and Alain
Algazi, MD, from the University of
California, San Francisco.
"Median overall survival in recurrent and metastatic HNSCC is
less than one year even with aggressive, multi-agent chemotherapy.
Immune checkpoint inhibitors, including anti-PD-1 antibodies, can
achieve durable remissions in some patients, but these therapies
are ineffective in the majority of patients because tumor-fighting
immune cells and signals are missing from the tumor," said Dr.
Algazi. "ImmunoPulse™ IL-12 allows tumors to produce key immune
signals and attract these immune cells, which can potentially
provide the missing link that will allow the majority of patients
to achieve long-term remission."
OMS-I130 is a single-arm, open-label study evaluating the safety
and anti-tumor activity of intratumoral DNA-based IL-12 with
electroporation in approximately 30 patients with
treatment-refractory metastatic and unresectable HNSCC. The key
endpoints include: objective response evaluations by RECIST v1.1
and immune-related Response Criteria (irRC); biomarker comparisons
of pre- and post-treatment tumor biopsies, including
NanoString® gene expression profiling and
immunohistochemistry for tumor-infiltrating lymphocytes (TILs);
duration of response to treatment; overall survival;
progression-free survival; and safety.
To learn more about the trial, visit www.oncosec.com. Additional
details can also be found at www.clinicaltrials.gov.
About Squamous Cell Carcinoma of the Head and Neck
Squamous cell carcinoma (SCC) of the head and neck is one of most
common causes of cancer-associated mortality worldwide. While the
incidence of SCC of the head and neck (HNSCC) that is attributable
to traditional risk factors, smoking and alcohol abuse, is
declining, the incidence of SCC of the oropharynx due to HPV
infection is on the rise.1
HNSCC can be treated with surgery, radiation, or chemoradiation
in 60-90 percent of patients, but a substantial number of patients
will develop recurrent or distant metastatic disease after
locoregional therapy. These recurrences are associated with a poor
overall prognosis2, and the median overall survival in
patients with metastatic HNSCC is under a year even with intensive
combination chemotherapy.3
The limited efficacy of standard of care treatment options means
that 11,500 patients die every year from squamous cell carcinoma of
the oral cavity and the oropharynx in the
United States alone.1 There is a clear medical
need in head and neck cancers for more effective treatment options
to minimize toxicity and improve efficacy.
About OncoSec Medical Inc.
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 limiting the systemic toxicities
associated with other treatments. OncoSec's lead program evaluating
ImmunoPulse™ for the treatment of metastatic melanoma is
currently in Phase II 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.
References:
1. Davies, L., et al. (2006).
"Epidemiology of head and neck cancer in the United States." Off J Am Acad
Otolaryngol-Head Neck Surg 135: 451–457.
2. Kowalski, L. P., et al. (2000). "Natural history of untreated
head and neck cancer." Eur J Cancer Oxf Engl 1990 36:
1032–1037.
3. Cohen, E. E. W., et al. (2004). "The expanding role of systemic
therapy in head and neck cancer." J Am Soc Clin Oncol 22:
1743–1752.
Contact:
Investor Relations:
Jordyn Kopin
OncoSec Medical Inc.
855-662-6732
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Inc.
855-662-6732
media@oncosec.com
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