SAN DIEGO and PENNINGTON, N.J., Dec.
11, 2018 /PRNewswire/ -- OncoSec Medical Incorporated
(OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer
immunotherapies, announced today the presentation of new data that
suggests treatment with TAVO™ (tavokinogene telseplasmid) has the
ability to improve immune responses in heavily pretreated,
inoperable and locally advanced triple negative breast cancers by
increasing tumor infiltrating lymphocyte (TIL) density, increasing
effector cytokines, and upregulating immune-related gene
expression, factors associated with long-term response to anti-PD1
antibodies.
The now completed Pilot
TNBC study, OMS-140 (NCT02531425), was designed to determine
whether a single cycle of TAVO™ monotherapy could enhance
anti-tumor immune responses in a TNBC salvage setting.
Specifically, a comparative analysis of patient's pre-TAVO™ tumor
and blood samples to the post-TAVO™ tumor and blood samples
demonstrated that, with only a single cycle of TAVO™, a
treatment-related increase of CD8+ TIL was observed in
four of 10 patients, while also demonstrating a relative decrease
in immune suppressive cells.
Nanostring analysis (a novel platform for quantification of gene
expression) of the tumor microenvironment revealed a meaningful
increase of immune-related transcripts while on treatment.
The investigator also evaluated the peripheral blood through
a longitudinal analysis of PBMCs (peripheral blood mononuclear
cells), and, in doing so, noted an increase of both effector and
partially exhausted T cells, which complements the reduced
frequency of immune-suppressive MDSC (myeloid-derived suppressor
cells) reported earlier this year at AACR.
These data, along with increased effector cytokines noted in
serum, demonstrate both local and systemic immune responses with
only one cycle of TAVO™ in this difficult to treat patient
population. Additionally, as observed in other clinical trials with
TAVO™, this study showed that TAVO™ is safe and well tolerated in
this patient population.
These data, as well as other clinical and immunological data,
were presented at the 2018 San Antonio Breast Cancer Symposium
(SABCS) taking place December 4-8 in
San Antonio, Texas.
"The immunological signatures described here, including
conversion of non-immunogenic tumors into immunologically active
lesions, are very encouraging, especially when considering that
patients with very advanced disease received only one cycle of
TAVO™," said Dr. Christopher Twitty,
Chief Scientific Officer of OncoSec. "Late-stage triple
negative breast cancer patients have very few treatment options,
and those that are available, come with serious toxicities and
limited effectiveness. Recent data suggest that some patients
with triple negative tumors will benefit from treatment with PD-1
checkpoint inhibitors, but only if the patient's tumor is
immunologically active," continued Dr. Twitty. "This study represents the potential of a
safe and effective immunotherapy to turn non-immunogenic tumors
into an immunologically active tissue, expanding the benefits of
PD-1 checkpoint inhibitors to a much broader subset of women with
triple negative breast cancer, which would be an important advance
for the treatment of these patients."
As previously reported, a subset of patients that completed a
single cycle of TAVO in this study, were sequentially treated with
an anti-PD-1 checkpoint therapy (nivolumab). Importantly,
some of these patients, one with prior disease progression on
anti-PD-L1 antibody monotherapy, experienced robust clinical
responses beyond the TAVO treated lesions. One of these
patients continues to be treated with TAVO under a
compassionate use protocol.
Based on these findings, OncoSec and Merck initiated a second
TAVO Phase 2 study in TNBC, KEYNOTE-890, to evaluate the
combination of TAVO with Merck's anti-PD-1 therapy KEYTRUDA®
(pembrolizumab) in approximately 25 patients with
treatment-refractory, inoperable or metastatic triple negative
breast cancer (NCT03567720).
Since KEYNOTE-890 opened in October, investigators have already
enrolled five patients into the trial. The KEYNOTE-890 study is
testing the combination in patients with inoperable locally
advanced or metastatic TNBC who have progressed on more than one
line of prior therapy. Patients will be treated with the
combination of TAVO with pembrolizumab. The primary endpoint is to
assess efficacy as measured by objective response rate (ORR) based
on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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 plasmid encoded IL-12
(tavokinogene telseplasmid 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.
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:
Will O'Connor
Stern Investor Relations
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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