SAN DIEGO, Feb. 23, 2017 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company
developing DNA-based intratumoral cancer immunotherapies, today
reported new positive clinical data from a Phase II Investigator
Sponsored Trial assessing the combination of OncoSec's
investigational intratumoral therapy, ImmunoPulse® IL-12, and the
approved anti-PD- 1 therapy (pembrolizumab), in patients with
unresectable metastatic melanoma. The results of this single-arm,
open-label trial, which was led by the University of California, San Francisco (UCSF),
indicated that ImmunoPulse® IL-12 can increase response rates in
patients who are not expected to respond to anti-PD-1 therapy
alone.
The trial is evaluating the following key endpoints: best
overall response rate (BORR) by 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 (PFS); median PFS; and overall survival
(OS). The study results showed an overall response rate (ORR) at 24
weeks of 43% (9/21), and BORR of 48% by RECIST v1.1. There were 24%
(5/21) complete responders (CR), 19% (4/22) partial responders
(PR), and 9% (2/21) stable disease (SD) for a total disease control
rate of 52% (11/21). These data are consistent with, and expand
upon, previously reported preclinical and clinical data that
provide a strong rationale for combining ImmunoPulse® IL-12 with
anti-PD-1 blockade.
"Collectively, these data suggest that intratumoral IL-12 DNA
with electroporation in combination with pembrolizumab can
effectively alter the tumor microenvironment by triggering adaptive
resistance," said Alain Algazi,
M.D., the study's lead investigator, and skin cancer
specialist in the Melanoma Center at the UCSF Helen Diller Family
Comprehensive Cancer Center. "This increases the substrate for a
therapeutic PD-1/PD-L1 blockade while driving systemic anti-tumor
immunity and concordant clinical responses in patients unlikely to
benefit from anti-PD-1 monotherapy."
Dr. Algazi presented the study findings today in an oral
presentation titled, "Immune monitoring outcomes of patients with
stage III/IV melanoma treated with a combination of pembrolizumab
and intratumoral plasmid interleukin 12 (pIL-12)" (Abstract #78),
at the ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, FL.
In this trial, a biomarker that has previously been shown to be
predictive of response to checkpoint inhibitor therapy was used to
enroll 22 patients who have a low likelihood of responding to an
anti-PD-1 therapy. These patients were treated with the combination
of intravenous pembrolizumab and ImmunoPulse® IL-12 for more than
24 weeks.
The combination therapy continued to demonstrate a favorable
safety profile and was well tolerated. Importantly, of the 22
patients enrolled, nine had previous checkpoint inhibitor therapy;
ORR for this subset of patients was 33% (3/9).
Comprehensive immune monitoring of blood and tissue samples
showed that the combination of ImmunoPulse® IL-12 with
pembrolizumab produces a safe and powerful systemic immune
response. This response leads to an increase in tumor-specific CD8+
T-cells and an "adaptive immune resistance" that broadly supports
an immune-directed mechanism that is differentiated between
responders and non-responders. Analysis of the biomarker data
suggests that the combination of ImmunoPulse® IL-12 with
pembrolizumab is transforming "cold" tumors, which would be
predicted to not respond to anti-PD-1 therapy, into "hot" tumors,
thus increasing the potential for a meaningful clinical response to
the checkpoint inhibitor therapy. Moreover, an analysis of
pre-treatment samples using various analytical methods that have
also been demonstrated to predict response to anti-PD-1 therapy,
including immunohistochemistry (IHC) and RNA expression of critical
immune-related genes by NanoString®, correlate with the predictive
biomarker used to enroll patients for this study.
"OncoSec's vision to bring intratumoral gene therapies to the
oncology market continues to advance with these positive, impactful
data, which hold immense promise for cancer patients who are
unlikely to benefit from immunotherapy," said Punit Dhillon, OncoSec President and CEO. "These
results provide a strong foundation for our planned Phase II
registration trial, which will evaluate the combination of
ImmunoPulse® IL-12 and an anti-PD-1 therapy in melanoma patients
who have previously failed an approved anti-PD-1 therapy alone. We
expect to initiate this study later in 2017."
The full-text abstract is available and can be viewed on
ASCO-SITC's website at www.immunosym.org. The presentation is
available in the Publications section of OncoSec's website.
About the ASCO-SITC Clinical Immuno-Oncology Symposium
The ASCO-SITC Clinical Immuno-Oncology Symposium is a three-day
meeting focused on clinical and translational research in
immuno-oncology and the implications for clinical care. This is a
new meeting, one that will address the high level of need for
clinical education in a field where all aspects of care are
fundamentally different from traditional therapies. For more
information, please visit www.immunosym.org.
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 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. 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
"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:
Punit Dhillon
President & Chief Executive Officer
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
Media:
Laura Radocaj
Dian Griesel International
212-825-3210
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SOURCE OncoSec Medical Incorporated