SAN DIEGO and PENNINGTON, N.J., Jan.
7, 2019 /PRNewswire/ -- OncoSec Medical Incorporated
(OncoSec) (NASDAQ:ONCS), a company developing novel cancer
immunotherapies, today announced it has established a collaboration
with the GOG Foundation, Inc., (GOG Foundation), to conduct a
registration-enabled study of TAVO™ (tavokinogene telseplasmid) in
women with recurrent/persistent cervical cancer
(OMS-150).
In June, 2018, KEYTRUDA® (pembrolizumab) received accelerated
approval from the FDA for the treatment of advanced
cervical cancer with disease progression during or after
chemotherapy based on data from a single-arm 98 patient study that
showed a 14% overall response rate (ORR). Previous data in
other advanced solid tumors demonstrate that TAVO combined with
KEYTRUDA can induce objective responses in patients who do not
respond to anti-PD-1 antibody monotherapy.
In this registration-directed clinical trial, OncoSec and GOG
will evaluate the combination of TAVO and commercially available
KEYTRUDA with the goal of achieving a clinically meaningful
response rate greater than what has already been demonstrated with
KEYTRUDA alone (14%). OncoSec and the GOG Foundation plan to enroll
approximately 80 to 100 patients, who qualify for standard of care
treatment with KEYTRUDA, in this single-arm study with TAVO. The
trial will be open to patients with surface or subcutaneous lesions
that are accessible via TAVO's current delivery system.
Patient enrollment is expected to begin in the first half of
2019. Importantly, should a clinically meaningful increase be
observed in patients receiving the TAVO beyond that which they
receive from KEYTRUDA alone, OncoSec plans to seek accelerated
approval of TAVO in this patient population.
"KEYTRUDA is only the second drug in 30 years to be approved for
the treatment of cervical cancer and, though it represents
significant progress, the number of patients who can benefit is
limited. Our goal is to improve upon the 14% KEYTRUDA
response rate with the addition of TAVO," said Daniel J. O'Connor, President and Chief
Executive Officer of OncoSec. "We believe that TAVO, our
proprietary intratumoral plasmid-based IL-12, is an excellent
complement for expanding the clinical benefit of anti-PD-1
therapies, especially for those patients that are resistant to
anti-PD-1 therapies. Given that KEYTRUDA is already approved
and reimbursed for this indication, this study fits perfectly with
our strategy of identifying opportunities to conduct small,
relatively low-cost single-arm clinical studies that have the
potential to offer a rapid path to drug approval and
commercialization."
The study will be conducted within GOG Foundation's
network under OncoSec's investigational new drug (IND)
application for TAVO. The GOG Foundation is a world-renowned
non-profit organization with the purpose of conducting clinical
research for the prevention and treatment of all gynecologic
cancers, such as ovarian cancer, cervical cancer, endometrial
cancer, vulvar cancer, and vaginal cancer. Its members make up a
multi-disciplinary group, consisting of gynecologic oncologists,
medical oncologists, pathologists, radiation oncologists, nurses,
statisticians, and basic scientists.
"Conducting research that can lead to promising new therapies
for women facing cervical cancer and other gynecological
malignancies is central to our mission, and this collaboration is
an exciting opportunity to bring our esteemed network and expertise
in quality scientific research to the table," said Larry J. Copeland, MD, GOG Foundation President.
"We're grateful to play a role in this trial and look forward to
advancing this therapy through the clinic."
About OncoSec Medical Incorporated
OncoSec is a
clinical-stage biotechnology company focused on developing
cytokine-based intratumoral immunotherapies to stimulate the body's
immune system to target and attack cancer. OncoSec's lead
immunotherapy platform – TAVO (tavokinogene telseplasmid) – enables
the intratumoral delivery of DNA-based interleukin-12 (IL-12), a
naturally occurring protein with immune-stimulating functions. The
technology, which employs electroporation, is designed to produce a
controlled, localized expression of IL-12 in the tumor
microenvironment, enabling the immune system to target and attack
tumors throughout the body. OncoSec has built a deep and
diverse clinical pipeline utilizing TAVO as a potential treatment
for multiple cancer indications either as a monotherapy or in
combination with leading checkpoint inhibitors; with the latter
potentially enabling OncoSec to address a great unmet medical need
in oncology: anti-PD-1 non-responders. Results from recently
completed clinical studies of TAVO have demonstrated a local immune
response, and subsequently, a systemic effect as either a
monotherapy or combination treatment approach. In addition to TAVO,
OncoSec is identifying and developing new DNA-encoded therapeutic
candidates and tumor indications for use with its ImmunoPulse®
platform. For more information, please visit www.oncosec.com.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
ImmunoPulse® is a registered trademark of OncoSec Medical
Incorporated, San Diego, CA,
USA.
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:
Stern Investor Relations
Will O'Connor
Phone: (212) 362-1200
will@sternir.com
Media Relations:
Michael Lampe
Scient Public Relations, Inc.
(484) 575-5040
michael@scientpr.com
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SOURCE OncoSec Medical Incorporated