UC San Francisco and OncoSec Medical Collaborate to Evaluate Investigational Combination of ImmunoPulse and Anti-PD-1 Treatment
November 25 2014 - 3:01AM
Business Wire
Investigator Sponsored Trial Led by Dr. Alain
Algazi and Supported by OncoSec and Merck Will Evaluate Combination
of KEYTRUDA® and ImmunoPulse in Metastatic Melanoma
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, has entered a
clinical collaboration with the University of California, San
Francisco (UCSF), to evaluate the safety, tolerability and efficacy
of the combination of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1
therapy, and OncoSec’s ImmunoPulse (intratumoral IL-12) in
metastatic melanoma.
Recent data suggest that patients who are PD-L1 positive and
have increased tumor-infiltrating lymphocytes (TILs) are more
likely to respond to anti-PD-1/PD-L1 mAbs compared to patients who
are PD-L1 negative. Therefore, therapies that promote TIL
generation and PD-L1 positivity may play an important role in
augmenting the clinical efficacy of these agents.
Interleukin-12 (IL-12) is an inflammatory cytokine believed to
be a master regulator of the immune system, promoting up-regulation
of both the innate and adaptive immune responses. More
specifically, IL-12 stimulates the production of another cytokine,
interferon gamma (IFN-γ), which results in the stimulation of
antigen processing and presentation machinery, leading to increased
TILs and anti-tumor cytotoxic T-cell (CTL) activity.
ImmunoPulse, an investigational intratumoral immunotherapy, uses
plasmid DNA that encodes for IL-12 and delivers it directly into
the tumor using a proprietary electroporation device. Preclinical
and clinical data suggest that local delivery and expression of
IL-12 with ImmunoPulse promotes tumor immunogenicity and increases
TILs without the toxicities associated with systemic IL-12
administration. Recent interim data from OncoSec’s ongoing Phase II
study have demonstrated that plasmid IL-12 electroporation
treatment increases IFN-γ production and increased expression of
genes related to antigen processing and presentation, including the
expression of PD-L1.
Punit Dhillon, President and CEO of OncoSec, said, “This
collaboration with Dr. Algazi and UCSF with support from Merck
marks the first clinical trial to evaluate the combination of an
anti-PD-1 antibody with an intratumoral therapy using
electroporation. Over the course of the last year, OncoSec has
continually stated the need to evaluate intratumoral therapies that
have the ability to convert the anti-PD-1 non-responder population
to responders. The design of this clinical trial will assess this
hypothesis, and we believe the combination of
OncoSec’s intratumoral immunotherapies and checkpoint
inhibitors holds significant promise for the treatment of melanoma
and other cancers. We look forward to sharing the results
from this clinical trial in the future."
Dr. Robert Pierce, Chief Scientific Officer of OncoSec, said,
“There is a strong rationale for combining a treatment like
ImmunoPulse, which increases TILs, with a T cell checkpoint therapy
like pembrolizumab, which then acts on those TILs. This study is
designed to test whether this combination increases patients’ TILs
and improves anti-tumor efficacy in low-TIL melanoma patients.”
Dr. Alain Algazi, principal investigator at UCSF, said, “The
PD-1 antibody pembrolizumab takes the brakes off of the
anti-melanoma immune responses. ImmunoPulse with IL-12 has the
potential to bring immune cells and signals into the tumor so that,
when pembrolizumab takes the brakes off the immune response, the
results could be devastating for the tumor and great for our
patients.”
This Phase II clinical trial will be conducted as a multicenter
Investigator Sponsored Trial (IST), with UCSF and Dr. Alain Algazi
as the sponsor. Merck will supply pembrolizumab, and OncoSec will
provide electroporation devices and plasmid IL-12. Enrollment is
expected to begin in Q1 2015.
About OncoSec Medical
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 without the systemic toxicities associated
with other treatments. OncoSec's lead program evaluating
ImmunoPulse for the treatment of metastatic melanoma is currently
in Phase 2 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.
UC Disclaimer
The information stated above was prepared by OncoSec Medical
Inc. 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.
Investor Relations:OncoSec Medical Inc.Jordyn Kopin,
855-662-6732investors@oncosec.comorPublic Relations:Dian Griesel
Int’l.Laura Radocaj, 212-825-3210lradocaj@dgicomm.com
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