OncoSec Medical Announces New Phase II Trial in Head and Neck Cancer Using ImmunoPulse
December 09 2014 - 6:02AM
Business Wire
Multi-center Study to Expand Pipeline Beyond
Skin Cancers
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, has initiated a
Phase II trial in squamous cell carcinoma of the head and neck
(SCCHN) using its proprietary ImmunoPulse platform. The multicenter
study is scheduled to be initiated in the first quarter of 2015,
with the University of California San Francisco, under the
direction of Dr. Alain Algazi as the first site of enrollment.
The study will enroll patients with treatment-refractory
metastatic and unresectable SCCHN, regardless of HPV status.
Eligible patients will receive up to nine cycles of IL-12
ImmunoPulse at six-week intervals and will be followed for clinical
response and safety. The first stage of the study will enroll 20
patients with measurable disease. If three or more objective
responses are observed, an additional 11 patients with measurable
disease will be treated, for a total of 31 patients. The primary
endpoint for this study will be best overall response by RECIST
1.1.
Dr. Mai H. Le, Chief Medical Officer at OncoSec, stated,
“Similar to melanoma, recent data suggest that in SCCHN,
tumor-infiltrating lymphocytes [TILs] are required to achieve
responses to anti-PD-1 drugs such as pembrolizumab. We believe that
as a single agent, IL-12 ImmunoPulse has the potential to convert
tumors from a low to a high-TIL state.”
Dr. Robert H. Pierce, MD, OncoSec’s Chief Scientific Officer,
said, “In addition to the clinical endpoints, this study is
designed to test the hypothesis that intratumoral IL-12
electroporation will enhance the infiltration of TILs and the
generation of a gene expression signature, which has been shown to
correlate with response to anti-PD-1 or anti-PD-L1 mAbs in a
variety of solid tumors. In essence, we are looking to see if we
can convert non-responders to responders.”
Worldwide, SCCHN affects approximately 500,000 people and is the
cause of death in up to 300,000 people. There are few treatment
options for SCCHN, and with high recurrence rates in locally
advanced disease, prognosis is generally poor with a five-year
survival rate of less than 50 percent. ImmunoPulse with
intratumoral plasmid IL-12 (pIL-12) is currently under clinical
evaluation for metastatic melanoma. Based on data presented at ASCO
2014, there is reason to believe that the biological mechanisms at
play in metastatic melanoma also have a role in SCCHN, thus
providing a strong rationale for the evaluation of IL-12
ImmunoPulse in this indication.
Punit Dhillon, CEO of OncoSec, said, “We believe ImmunoPulse has
the ability to demonstrate efficacy beyond skin cancers and into
new solid tumor indications. Head and neck cancer represents an
opportunity for IL-12 ImmunoPulse to deliver on the promise of this
technology to another area of unmet medical need. It is another
indication where we believe ImmunoPulse is a rational combination
therapy with checkpoint inhibitors and has the potential to greatly
expand the number of patients who can benefit from treatment.”
About Squamous Cell Carcinoma of the Head and Neck
Worldwide, there are approximately 560,000 new cases of head and
neck cancer diagnosed and 300,000 deaths each year. Incidence rates
are more than twice as high in men than in women. Oral cavity
cancer is the most common type of head and neck cancer with 240,000
cases diagnosed every year, while cancers of the larynx, pharynx,
thyroid and nasopharynx are less common.
Currently, the main treatment options for head and neck cancers
are surgery, radiotherapy and chemotherapy. The types of treatment
used will depend on the site and disease stage as well as on the
patient’s overall health status.
In locally advanced head and neck cancer, chemoradiotherapy is
an important option. However, due to high recurrence rates,
patients with locally advanced disease tend to have a poor
prognosis. For patients with advanced (metastatic) or recurrent
disease, treatment options are limited. Despite the introduction of
chemotherapy treatment in this setting approximately 30 years ago,
patients with advanced (metastatic) or recurrent head and neck
cancer still have a poor prognosis, with median survival of 6-10
months. 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
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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