SAN DIEGO, June 16, 2016 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
presented preliminary findings from 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). These preliminary findings, indicating that
ImmunoPulse™ IL-12 may lead to an increase in CD8+ T-cells
and 'adaptive immune resistance' in HNSCC patients, are consistent
with preclinical and clinical data previously reported in other
indications. Together, the data from these multiple studies support
a rationale for combining ImmunoPulse™ IL-12 with anti-PD-1
blockade therapies.
Robert H. Pierce, MD, Chief
Scientific Officer at OncoSec, presented the findings in an oral
presentation entitled: "Intratumoral IL-12 Therapy in HNSCC: Can
In-Situ Vaccination Solve the Problem of Anti-PD-1 Non-Response?"
at the EUROGIN 2016 Conference in Salzburg, Austria. The oral presentation is
part of the conference session entitled: "Updates on Immunotherapy
Trials in HPV-HNSCC," chaired by Sara I.
Pai, MD, PhD, a faculty member at Massachusetts General Hospital and Harvard Medical School and co-author of the
abstract.
Dr. Pierce described a role for intratumoral immunotherapy in
driving anti-tumor CD8+ responses and altering the immune
environment to enable tumors to become responsive to anti-PD-1
blockade. Specifically, Dr. Pierce described new cases from the
single-agent ImmunoPulse™ IL-12 Phase II HNSCC trial, in which
intratumoral electroporation of DNA-based IL-12 drove a CD8+ T-cell
response and associated increase in interferon-gamma-related genes
in some patients. Moreover, one patient, who went on to receive
anti-PD-1 therapy in combination with ImmunoPulse™ IL-12,
experienced a significant tumor regression and has an ongoing
partial response.
"Although we have treated only four patients to date, these data
in patients with head and neck cancer are entirely consistent with
our previous studies in melanoma and Merkel cell carcinoma as well
as our preclinical models—namely, that in-situ vaccination with
plasmid IL-12 can convert low-TIL, poorly-inflamed tumors into
high-TIL inflamed tumors. That conversion may augment responses to
T-cell checkpoint therapy, such as anti-PD-1 antibodies," said Dr.
Pierce.
The lead investigators for OMS-I130 are Tanguy Seiwert, MD, from the University of Chicago and Alain Algazi, MD, from the University of California, San Francisco. OMS-I130
is a single-arm, open-label study evaluating the safety and
anti-tumor activity of ImmunoPulse™ IL-12 in patients with
treatment-refractory metastatic and unresectable HNSCC. The trial
(NCT02345330) is open, but currently not recruiting
patients.
"We have paused enrollment in the HNSCC trial for two main
reasons. First, we are currently focusing our internal resources on
moving toward a registration trial in melanoma. Additionally, our
strategy is aimed at demonstrating that ImmunoPulse™ IL-12 is a
rational choice for combination therapy with anti-PD-1/PD-L1 and
that ImmunoPulse™ IL-12 will increase the number of patients who
will benefit from these treatments," said Punit Dhillon, President and CEO. "As approval
of one or more of the PD-1/PD-L1 antibodies in HNSCC seems likely
in the near term, we will explore a combination of our technology
with the approved agent at that time."
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based
intratumoral immunotherapies with an investigational technology,
ImmunoPulse™, for the treatment of cancer. ImmunoPulse™ is
designed to enhance the local delivery and uptake of DNA-based
immune-targeting agents, such as IL-12. In Phase I and II clinical
trials, ImmunoPulse™ IL-12 has demonstrated a favorable safety
profile and evidence of anti-tumor activity in the treatment of
various skin cancers and has shown the potential to reach beyond
the site of local treatment to initiate a systemic immune response.
OncoSec's lead program, ImmunoPulse™ IL-12, is currently in
clinical development for several indications, including metastatic
melanoma and triple-negative breast cancer. In addition to
ImmunoPulse™ IL-12, the Company is also identifying and developing
new immune-targeting agents for use with the ImmunoPulse™ platform.
For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements"
within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995. Forward-looking statements can be identified by words
such as "can," "may," "will," "suggest," "look forward to,"
"potential," "understand," and similar references to future
periods.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they 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.
Potential risks and uncertainties that could cause actual results
to differ from those predicted include, among others, the
following: uncertainties inherent in pre-clinical studies and
clinical trials, such as the ability to enroll patients in clinical
trials and the risk of adverse events; unexpected new data, safety
and technical issues; our ability to raise additional funding
necessary to fund continued operations; and the other factors
discussed in OncoSec'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
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.
CONTACT:
Mary
Marolla
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
Logo -
http://photos.prnewswire.com/prnh/20120905/LA68078LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/oncosec-presents-preliminary-findings-from-head-and-neck-phase-ii-clinical-trial-at-eurogin-2016-conference-300285668.html
SOURCE OncoSec Medical Incorporated