SAN DIEGO, Oct. 10, 2017 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a
company developing intratumoral cancer immunotherapies, today
announced that it has initiated its phase 2b registration directed
trial, PISCES/KEYNOTE-695. The PISCES/KEYNOTE-695 study is a
global, multicenter phase 2b trial of OncoSec's investigational
therapy, ImmunoPulse® IL-12 (intratumoral pIL-12 [tavokinogene
telseplasmid or "tavo"] with electroporation), combined with
KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy marketed
by Merck (known as MSD outside the US and Canada), in
patients with unresectable metastatic melanoma who have progressed
or are progressing on an anti-PD-1 therapy.
"Patients with metastatic melanoma who are progressing or have
progressed on anti-PD-1 therapy have limited treatment options. We
believe the combination of ImmunoPulse IL-12 and pembrolizumab
offers a potentially transformative approach for these patients
given the absence of approved therapies," said Punit Dhillon, CEO and President at OncoSec.
"The advancement of the PISCES trial marks an important milestone
for the Company."
The phase 2b, Simon 2-stage multicenter study of intratumoral
tavo with electroporation in combination with intravenous KEYTRUDA
will enroll approximately 48 patients with histological diagnosis
of melanoma with progressive locally advanced or metastatic disease
defined as Stage III or Stage IV. The primary endpoint will be the
Best Overall Response Rate (BORR).
"ImmunoPulse IL-12 and pembrolizumab are immunotherapies
designed to modulate the patient's own immune response to fight
cancer," said Sharron Gargosky Ph.D., Chief Clinical and Regulatory
Officer at OncoSec. "We are pleased with the progress of the
ongoing PISCES trial, which has benefitted from our clinical trial
collaboration and supply agreement with Merck."
The collaboration agreement, which was announced in May 2017, 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.
To learn more about the trial, visit www.oncosec.com. Additional
details can also be found at www.clinicaltrials.gov via
NCT03132675.
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 Metastatic Melanoma1
Melanoma is a type of skin cancer that begins in skin cells
called melanocytes. As the cancer progresses, melanoma becomes more
difficult to treat once it spreads beyond the skin, such as the
lymphatic system (metastatic disease). Given its occurrence young
individuals, the potential years of life lost to melanoma can be
higher when compared with other cancers. Although melanoma is a
rare form of skin cancer, it accounts for over 75% of skin cancer
deaths. The American Cancer Society estimates that approximately
87,000 new melanoma cases and 10,000 deaths from the disease will
occur in the United States in
2017. Additionally, the World Health Organization estimates that
approximately 132,000 new cases of melanoma are diagnosed around
the world every year.
1 American Cancer Society
(https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html);
World Health Organization
(http://www.who.int/uv/faq/skincancer/en/index1.html)
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination
Electroporation Study)
PISCES is a global, multicenter phase 2b, open-label trial of
intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or
"tavo") delivered by electroporation in combination with
intravenous pembrolizumab in patients with stage III/IV melanoma
who have progressed or are progressing on either pembrolizumab or
nivolumab treatment. The Simon 2-stage study of intratumoral tavo
plus electroporation in combination with pembrolizumab will enroll
approximately 48 patients with histological diagnosis of melanoma
with progressive locally advanced or metastatic disease defined as
Stage III or Stage IV. The primary endpoint will be the 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 (tavokinogene telseplasmid
[pIL-12] or "tavo"). In Phase 1 and 2 clinical trials,
ImmunoPulse® IL-12 has demonstrated a favorable safety
profile, evidence of anti-tumor activity in the treatment of
various solid tumors, and the potential to reach beyond the site of
local treatment to initiate a systemic 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 have
relapsed on anti-PD-1 therapies. In addition to tavo, 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, including statements about OncoSec's business strategies,
including advancement of its lead melanoma program and its broader
clinical portfolio and plans to pursue collaborations with industry
partners, as well as the potential contributions and impact of new
directors on these strategies. 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 OncoSec's 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 substantial time, costs and
unpredictability of such studies and trials, the ability to enroll
patients in clinical trials and the risk of adverse events;
unexpected new data, safety and technical issues; OncoSec's 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, including its quarterly report
on Form 10-Q for the quarter ended April 30,
2017.
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
Phone: 855-662-6732
investors@oncosec.com
Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com
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SOURCE OncoSec Medical Incorporated