SAN DIEGO, Nov. 8, 2016 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, announced today
that new clinical data are being presented from a Phase II
Investigator Sponsored Trial led by the University of California, San Francisco (UCSF).
This single-arm, open-label trial assessed the combination of
OncoSec's investigational intratumoral therapy,
ImmunoPulse® IL-12, and Merck's KEYTRUDA®
(pembrolizumab) in patients with unresectable metastatic melanoma.
A predictive biomarker was used to enroll patients that have a low
likelihood of response to an anti-PD1 agent alone, and the purpose
of the trial is to assess whether the addition of
ImmunoPulse® IL-12 can increase response rates in these
patients. The data will be presented at an oral poster presentation
(#466) by Dr. Alain Algazi at the
Society for Immunotherapy of Cancer ("SITC") Annual Meeting in
National Harbor, MD on November 11,
2016 at 12:50 PM EST.
In August 2016, OncoSec announced
the publication of a research assay in the Journal of Clinical
Investigation that might be used as a predicative biomarker in
melanoma patients. The assay shows that patients with a low
frequency of a certain phenotype of CD8 T cells, pre-disposes them
to low response rates to PD-1 inhibitor therapy alone. The Company
is using this biomarker assay to select patients considered to be
PD-1 non responders for this ongoing combination study. The key
endpoints of the study include: best overall response rate by the
Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and
immune-related Response Criteria; safety and tolerability; duration
of response; 24-week landmark progression-free survival; median
progression-free survival; and overall survival.
Results
Interim efficacy and safety data are available
on 15 patients. In patients considered unable to respond to PD-1 we
measured an overall response rate of 40% (6 /15), consisting
of 4 complete responses and 2 partial responses by RECISTv1.1
criteria. Additionally, the therapy has an acceptable safety
profile and was well tolerated. Analysis of tumor biopsies and
blood correlated with patients' responsiveness and demonstrated
correlative immunological changes including an increased number of
CD8+ tumor-infiltrating lymphocytes, tumoral RNA
signatures and concordant immune phenotypes in the periphery.
Investigators concluded that the combination of
ImmunoPulse® IL-12 with pembrolizumab in patients with
an anti-PD-1 non-responsive phenotype enables an effective
anti-PD-1 response.
Punit Dhillon, CEO of OncoSec,
stated: "These results validate our therapeutic hypothesis for the
ability of ImmunoPulse® IL-12 to improve response rates
in advanced melanoma. We wish to thank the investigators and
patients for their continued participation in this study. We are
working diligently to advance this agent towards
registration-enabling studies, and we look forward to providing
additional details regarding the Company's operations and strategy
at our upcoming Investor and Analyst Day on November 17, 2016."
Alain Algazi, M.D., Principal
Investigator from UCSF, stated: "Although this open-label study is
still ongoing and data are maturing, I am encouraged by the
meaningful interim response rates that the combination of
ImmunoPulse® IL-12 and pembrolizumab has been able to
achieve in a patient population otherwise expected to respond
poorly to pembrolizumab alone. While checkpoint inhibition has
conferred meaningful clinical benefit for advanced melanoma
patients, there remains an urgent need to increase these agents'
efficacy through the rational combination with other
immunotherapies. I look forward to the continued maturation of this
data and to further reporting on the trial's progress."
For more information about this trial, please visit:
https://clinicaltrials.gov/ct2/show/NCT02493361?term=pIL-12&rank=3
About the SITC Annual Meeting
The Society for
Immunotherapy of Cancer (SITC) is a non-profit medical
professional society of influential scientists, academicians,
researchers, clinicians, government representatives, and industry
leaders from around the world dedicated to improving cancer patient
outcomes by advancing the science and application of cancer
immunotherapy. Currently, SITC has nearly 1,600 members
representing 17 medical specialties and are engaged in research and
treatment of at least a dozen types of cancer. The 31st SITC
Annual Meeting & Associated Programs will take place
November 11-13, 2016 at the
Gaylord National Hotel & Convention Center in National Harbor,
MD. For more information, please go to
http://www.sitcancer.org/2016.
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 solid tumors 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,
head and neck cancer, and triple-negative breast cancer. The
program's current focus is on the significant unmet medical need in
patients with melanoma who are refractory or non-responsive to
anti-PD-1/PD-L1 therapies. 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.
University of California
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 "will," "can," 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
Sophia Ononye,
PhD MPH MBA
Associate Director, Investor Relations and Corporate
Communications
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
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SOURCE OncoSec Medical Incorporated