SAN DIEGO, May 7, 2015 /PRNewswire/ -- OncoSec Medical
Inc. ("OncoSec") (OTCQB: ONCS), a company developing DNA-based
intratumoral cancer immunotherapies, presented preliminary findings
indicating that ImmunoPulse™ IL-12 can increase tumor
infiltrating lymphocytes (TILs) in patients with Merkel cell
carcinoma and melanoma. ImmunoPulse™ IL-12, which employs
intratumoral electroporation to enhance delivery of DNA-based
interleukin-12 (IL-12), is designed to promote anti-tumor activity.
These interim findings are consistent with preclinical data and
support a rationale for combining ImmunoPulse™ IL-12 with anti-PD-1
and other checkpoint therapies.
Dr. Pierce was an invited speaker at the 11th Annual
PEGS Conference in Boston. In his
presentation, entitled: "Taking the Fight to the Tumor - A
Rationale for Intratumoral Therapy in Combination with Anti-PD1
Blockade," Dr. Pierce described a role for intratumoral
immunotherapy as a powerful means to reveal critical "private"
tumor antigens and drive anti-tumor CD8+ responses. Specifically,
Dr. Pierce described new cases from the single-agent
ImmunoPulse™ IL-12 Phase I melanoma trial and Phase II
Merkel cell carcinoma trial, which showed intratumoral
electroporation of DNA-based IL-12 drove a CD8+ TIL response.
"Although preliminary, these observations from tumor samples
obtained from patients with melanoma and Merkel cell carcinoma
participating in our clinical trials point toward activation of
anti-cancer immunity, providing additional evidence that OncoSec's
intratumoral immunotherapies may play an important role in the
future of cancer treatment," said Punit
Dhillon, President and CEO of OncoSec. "We look forward to
presenting further results at upcoming scientific conferences as we
continue to analyze data from these trials."
OncoSec's collaborators at the University
of Washington, Paul Nghiem,
MD, PhD, and Shailender Bhatia, MD,
are conducting an exploratory analysis of samples collected from
patients in the Phase II single-agent study in Merkel cell
carcinoma, which completed enrollment in January of this year.
Final clinical results from the Phase II Merkel cell carcinoma
study are expected later this year.
"While we continue to analyze the tumor samples from these
trials, the preliminary findings are exciting and point to
ImmunoPulse™ IL-12 doing what it's supposed to do: enhance
immunogenicity and drive an anti-tumor TIL response," said Dr.
Pierce. "Combined with the preclinical data on IL-12
electroporation and our gene expression data from melanoma samples,
I am increasingly confident that intratumoral expression of IL-12
is pushing the immune system in the right direction."
About Phase II Merkel Cell Carcinoma Study
This Phase
II open-label, trial in Merkel cell carcinoma is evaluating the
safety, preliminary intratumoral activity, and IL-12 protein
expression following intratumoral injection of DNA-based IL-12
followed by electroporation in 15 patients with local and distant
Merkel cell carcinoma. Other exploratory endpoints of the study
include intratumoral biomarkers of inflammation. Enrollment in the
study is complete.
About Phase I Melanoma Study
This Phase I open label
dose escalation trial of DNA-based IL-12 electroporation was
carried out to assess safety and explore anti-tumor activity in 24
patients with metastatic melanoma. Patients were treated at seven
dose levels, with minimal systemic toxicity. Transient pain (Grades
1 and 2) associated with the electroporation procedure was the most
frequently reported adverse event. Post-treatment biopsies showed
plasmid increases in IL-12 protein levels as well as marked tumor
necrosis and lymphocytic infiltrate. Two (10%) of 19 patients with
nonelectroporated distant lesions that did not receive other
systemic therapy had a complete response to therapy, including
metastatic disease, whereas eight additional patients (42%) showed
disease stabilization.
About PEGS: The Essential Protein Engineering
Summit
PEGS is the premier event for antibody and protein
science research, and the biologics industry with more than 1,800
participants in attendance from over 30 countries. This year's
summit takes place in Boston from
May 4-8, 2015 and features 21
conferences and 40 roundtable sessions. For more information,
please visit www.pegsummit.com.
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.
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SOURCE OncoSec Medical Incorporated