SAN DIEGO, May 10, 2017 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, has entered a
clinical trial collaboration and supply agreement with Merck (known
as MSD outside the United States
and Canada) to evaluate the
combination of OncoSec's ImmuoPulse® IL-12 with Merck's anti-PD-1
therapy KEYTRUDA® (pembrolizumab) in a Phase II clinical trial,
referred to as PISCES. The planned clinical trial will
evaluate the safety and efficacy of the combination in patients
with metastatic melanoma following disease progression on previous
treatment with an anti-PD-1 therapy.
"We are honored to collaborate with Merck – one of the world's
leading cancer immuno-oncology companies – to help bring innovative
cancer treatments to patients with unmet medical needs," said
Punit Dhillon, CEO and President of
OncoSec. "This collaboration is supported by our recent clinical
data demonstrating the potential ability of ImmunoPulse®
IL-12 to rescue patients who do not initially respond to anti-PD-1
therapy in melanoma. In addition to our recent Fast Track
Designation for this population, OncoSec is uniquely positioned to
meaningfully impact clinical outcomes for patients who do not
currently have any other options. By working with innovative
immuno-oncology leaders, this alliance underpins OncoSec's strategy
to combine our ImmunoPulse® IL-12 program with
checkpoint inhibitor therapies to advance the care of
patients."
Eligible patients for this Phase II study will be those with
Stage III/IV metastatic melanoma who are progressing, or have
progressed, on previous treatment with an anti-PD-1 therapy. The
collaboration agreement is between OncoSec Medical Incorporated and
Merck, through a subsidiary. Under the agreement, OncoSec will
sponsor and fund the study and Merck will provide KEYTRUDA®.
Additional details of the collaboration were not disclosed.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
ImmunoPulse® is a registered trademark of OncoSec
Medical Incorporated, San Diego,
CA, USA.
About PISCES
PISCES (Anti-PD-1 IL-12 Stage III/IV
Combination Electroporation Study) will be a
Phase II multicenter study of ImmunoPulse® IL-12 in combination
with KEYTRUDA® in patients with histological diagnosis of melanoma
with progressive locally advanced or metastatic disease defined as
Stage III or Stage IV. Eligible patients will be those with Stage
III/IV metastatic melanoma who are progressing or have progressed
on an approved anti-PD-1 therapy. The primary endpoint for this
registration-directed trial will be best overall response rate
(BORR).
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 clinical and immune
response. OncoSec's lead program, ImmunoPulse® IL-12, is currently
in clinical development for 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.
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:
Investor Relations:
OncoSec Medical Incorporated
855-662-6732
investors@oncosec.com
Media Relations :
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
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SOURCE OncoSec Medical Incorporated