SAN DIEGO, June 6, 2016 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
announced that its collaborators at the University of California San Francisco (UCSF)
presented results at the American Society of Clinical Oncology
(ASCO) Annual Meeting, demonstrating the utility of a T-cell
exhaustion marker to predict response to anti-PD-1 monotherapies.
Authors of this poster discussion session from UCSF include
Adil Daud, MD, Alain Algazi, MD, and Michael Rosenblum, MD, PhD. This "low-tumor
infiltrating lymphocyte" (TIL) marker is currently being used to
select patients for the ongoing Phase II investigator-sponsored
clinical trial evaluating the combination of OncoSec's
investigational therapy, ImmunoPulse™ IL-12, and the approved
anti-PD-1 therapy, pembrolizumab, in patients with unresectable
metastatic melanoma.
Using samples from prior trials, authors presented results from
a total of 53 patients evaluable for both response and the T-cell
exhaustion marker (TEx). Fifteen patients were treated with a
combination of ipilimumab and nivolumab, and 38 with monotherapy
anti-PD-1. Patients determined to be "low-TIL" (TEx ≤20%) had 0/12
(0%) responses to anti-PD-1 therapy, while patients who were
"high-TIL" (TEx >20%) had 21/26 (81%) responses. Median TEx was
40.3% for responders and 16% for non-responders. Using a threshold
of TEx at 20%, the negative predictive value for response was 100%
and the positive predictive value was 81%. For patients treated
with the combination of ipilimumab and nivolumab, the TEx threshold
predictive of response was much lower. The authors concluded that
this novel T-cell exhaustion marker (% TEx) is an accurate
predictor of response to monotherapy, but not response to
combination therapy with ipilimumab and nivolumab.
OncoSec is currently enrolling patients into the Phase II
clinical trial led by UCSF to assess the anti-tumor activity,
safety, and tolerability of the combination of ImmunoPulse™ IL-12
and pembrolizumab. This multi-center, open-label, single-arm trial
is the first study to select patients for "low-TIL" status using
UCSF's T-cell exhaustion marker assay. The study will test the
hypothesis as to whether the addition of ImmunoPulse™ IL-12 to
pembrolizumab can increase the response rate in low-TIL melanoma
patients, who have a low likelihood of responding to monotherapy
with anti-PD-1 blockade. The key endpoints of the study include:
best overall response rate (BORR) by RECIST v1.1 and immune-related
Response Criteria (irRC); safety and tolerability; duration of
response; 24-week landmark progression-free survival; median
progression-free survival; and overall survival.
"We are delighted that our collaborators are presenting data at
ASCO demonstrating the utility of the flow cytometric TIL assay,"
said Robert H. Pierce, MD, Chief
Scientific Officer at OncoSec. "Our ongoing investigator-sponsored
combination trial of ImmunoPulse™ IL-12 and pembrolizumab hinges on
the strong predictive value for poor treatment outcomes from this
assay. Given these data, we are confident that we will be able to
robustly identify a combination efficacy signal in our ongoing
single-arm trial."
For more information about this trial, please visit:
http://oncosec.com/clinical-pipeline/.
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 as well as the potential 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.
UC Disclaimer
The information stated above was prepared by OncoSec Medical
Incorporated and reflects solely the opinion of the corporation.
Nothing in this statement shall be construed to imply any support
or endorsement of OncoSec, or any of its products, by The Regents
of the University of California, its
officers, agents and employees.
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," "hypothesis," "look forward to,"
"potential," 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
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