SAN DIEGO and PENNINGTON, N.J, Dec.
12, 2018 /PRNewswire/ -- OncoSec Medical Incorporated
(OncoSec) (NASDAQ:ONCS), a company developing novel cancer
immunotherapies, today announced an update regarding tumor
responses in its KEYNOTE-695 global, multicenter Phase 2b, open-label trial of intratumoral delivery of
TAVO™ (tavokinogene telseplasmid / IL-12) with intravenous
KEYTRUDA® (pembrolizumab) in patients with unresectable, advanced
melanoma. The Company previously reported at the Society for
Immunotherapy of Cancer's 33rd Annual Meeting (SITC) that, of the
first nine patients to complete 12 weeks of treatment and reach
initial tumor evaluation (by RECIST v1.1), two patients had a
partial response. The Company now reports that both responses
have been confirmed by blinded independent review at the first
assessment timepoint. Further, in both cases, response
duration has now reached six months. Importantly, one of
these previously assessed partial responses has now become a
complete response per investigator assessment at the six-month
tumor evaluation timepoint. Enrollment is ongoing and the Company
expects to complete the study next year.
"Complete responses in this patient population are rare.
One of the first partial responses to be observed in this study now
being assessed by the investigator at six months as a complete
response is exciting. Durable responses reaching the
six-month mark demonstrate that the benefits of TAVO are clinically
meaningful," said Daniel J.
O'Connor, President and CEO of OncoSec. "The evidence
of the potential of TAVO™ in conjunction with PD-1 inhibition to
improve outcomes in this patient population is mounting and we look
forward to providing updates as necessary regarding the progress of
this trial."
KEYNOTE-695 enrollment criteria with respect to
anti-PD-1 checkpoint failure is highly restrictive. In order to be
considered an anti-PD-1 checkpoint failure, all patients must have
Stage III/IV metastatic melanoma progressive disease after at least
four prior cycles of either KEYTRUDA® or OPDIVO®.
Literature suggests that retreatment with a PD-1 therapy following
failure of a PD-1 therapy offers approximately a 5% response
rate1. Disease progression is determined according
to RECIST v1.1, measured by radiologic assessment, with
confirmation of progression by second assessment.
"It's becoming clear that TAVO™ can reverse PD-1 resistance in
refractory metastatic melanoma patients. This is important
because the majority of melanoma patients do not respond to PD-1
treatment," said Adil Daud, MD, HS
Clinical Professor, Department of Medicine (Hematology/Oncology),
UCSF; Director, Melanoma Clinical Research, UCSF Helen Diller
Family Comprehensive Cancer Center and Lead Principle Investigator
of KEYNOTE-695. "Patients in KEYNOTE-695 have unequivocally
failed all approved anti-PD-1 therapies. The tumor responses seen
in this trial, now independently verified by a blinded review at
the first assessment, deepening and continuing for months, gives us
confidence in the potential of this treatment combination for
patients who are non-responsive to anti-PD-1 therapy."
Eligible patients in KEYNOTE-695 had refractory, locally
advanced or metastatic disease defined as unresectable Stage III/IV
metastatic melanoma that had definitively progressed on a
full-course of anti-PD-1 treatment with KEYTRUDA® (pembrolizumab)
or OPDIVO® (nivolumab). As previously reported, TAVO™ was
well-tolerated, with primarily Grade 1 adverse advents associated
with injection site or procedural pain. One TAVO™ related
Grade 3 SAE of cellulitis was reported and resolved.
KEYNOTE-695 is expected to be completed in 2019. Based
on the outcome of the study, the Company plans to file for
accelerated approval by end of 2019 or early 2020.
TAVO™ has received both Orphan Drug and Fast-Track
Designation by the U.S. Food & Drug
Administration.
1 Long GV, Weber JS, Larkin J et al. Nivolumab
for patients with advanced melanoma treated beyond progression:
analysis of 2 Phase 3 clinical trials. JAMA Oncol. 3(11),
1511–1519 (2017).
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.
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:
David Schemelia / Jason Rando
Tiberend Strategic Advisors, Inc.
Phone: 212-827-0020
dschemelia@tiberend.com
jrando@tiberend.com
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SOURCE OncoSec Medical Incorporated