SAN DIEGO and PENNINGTON, N.J., May
23, 2019 /PRNewswire/ -- OncoSec Medical Incorporated
(OncoSec) (NASDAQ: ONCS), a late-stage cancer biotechnology company
developing intratumoral gene-delivery immunotherapies, today
announced that the first patient has been dosed in TRIFECTA, a
triple combination clinical trial of OncoSec's TAVO™, an IDO1 drug
(epacadostat) and KEYTRUDA® in patients with unresectable squamous
cell carcinoma head and neck (SCCHN) cancer. The study is
being led by Dr. Chase Heaton, M.D.,
a leading oncologic head and neck surgeon at UCSF, and was
developed in collaboration with Dr. Alain
Algazi, leader of the Head and Neck Medical Oncology Program
at UCSF and Clinical Strategic Advisor to OncoSec.
Preliminary data from the TRIFECTA study is anticipated later this
year.
The TRIFECTA study capitalizes on findings from a 2017 plot
study of TAVO in head and neck cancer patients, which demonstrated
impressive clinical and biological results including evidence of
synergy between TAVO™, and PD-1 antibodies in the disease.
One of the patients in the 2017 pilot study, who experienced
a remarkable tumor response following TAVO™ treatment, was featured
in a LA Times in an article entitled, "I have terminal cancer
and I know my friends want to ask, 'Aren't you dead
yet?'"
A link to the LA Times article can be found here:
https://www.latimes.com/opinion/op-ed/la-oe-welsh-cancer-immunotherapy-20160717-snap-story.html.
The triple combination of IL-12, IDO1 and anti-PD-1 monoclonal
antibody is a first-of-its-kind clinical trial and is seeking to
exploit individual anti-tumor properties of each modality.
The goal of the study is to evaluate this three-way combination in
SCCHN cancer and, if promising, to potentially evaluate the triple
combination in other tumor types.
TRIFECTA is an investigator-initiated, single-arm, open-label
clinical trial in which 35 evaluable SCCHN patients will receive
TAVO™, pembrolizumab, and epacadostat. The primary endpoint
of the study is overall response rate (ORR) by RECIST v1.1 and will
be compared to historical data for pembrolizumab monotherapy in
SCCHN and to existing data regarding the combination of
pembrolizumab and epacadostat. The study is being conducted
by the UCSF Helen Diller Family Comprehensive Cancer
Center.
"Despite advancements in the field of immunotherapy, patients
with unresectable SCCHN have had limited success when treated with
anti-PD-1 antibodies as a monotherapy. Given TAVO's ability
to reverse anti-PD-1 resistance in patients with a variety of tumor
types, we are hopeful this triplet combination will benefit this
vulnerable patient population," said Daniel
O'Connor, President and CEO of OncoSec. "The start of this
investigator-initiated clinical trial marks an important milestone
for OncoSec and we look forward to reporting preliminary data from
this study later this year."
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 investigational product
candidate – 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 new
Visceral Lesion Applicator (VLA), to target deep visceral lesions,
such as liver, lung or pancreatic lesions. For more information,
please visit www.oncosec.com.
TAVO™ trademark of OncoSec Medical Incorporated.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
CONTACT
Investor Relations:
Will O'Connor
Stern Investor Relations
(212) 362-1200
will@sternir.com
Media Relations:
Katie Dodge
JPA Health Communications
(617) 657-1304
kdodge@jpa.com
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SOURCE OncoSec Medical Incorporated