OncoSec Reports Positive Top-Line Six-Month Primary Endpoint Data from Phase II Melanoma Trial of ImmunoPulse Monotherapy
December 05 2014 - 11:40AM
Business Wire
Best Overall Response Rate of 31 Percent
Complete Response Rate of 14 Percent
Disease Control Rate of 48 Percent
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
DNA-based intratumoral cancer immunotherapies, released top-line
six-month data from the first Phase II trial of its investigational
intratumoral plasmid IL-12 electroporation (pIL-12 EP) monotherapy
(ImmunoPulse IL-12) in patients with Stage III and IV metastatic
melanoma. Dr. Robert H. Pierce, Chief Scientific Officer at
OncoSec, a co-author of the study, presented these data today in an
abstract at the Melanoma Bridge 2014 conference in Naples,
Italy.
In this Phase II study, 30 patients with stage III-IV melanoma
received up to four cycles of pIL-12 EP into superficial cutaneous,
subcutaneous and nodal lesions on Days 1, 5 and 8 of each 12-week
cycle. Tumor responses were evaluated using modified RECIST
criteria for cutaneous lesions. The primary endpoint of the study
was best overall response rate (bORR) by modified RECIST. In the 29
response-evaluable patients, bORR was 31 percent (9/29), with 14
percent (4/29) of patients achieving a complete response (CR).
Regression of at least one non-injected, non-electroporated lesion
was observed in 50 percent (13/26) of patients.
Dr. Mai H. Le, Chief Medical Officer, stated, “Along with the
Phase I long-term survival analysis presented yesterday, these data
continue to support the use of pIL-12 EP as a treatment for
metastatic melanoma. Importantly, our observation that non-treated
lesions regress in approximately half of the patients suggests that
local, intratumoral pIL-12 EP successfully induces a more global
anti-tumor immune-mediated response.”
The most common treatment-related adverse event (AE) reported
was transient Grade 1/2 pain at the treatment site, reported in 87
percent (26/30) of patients. The reports of pain were directly
associated with the procedure and the median duration of pain was
one minute. Only one Grade 3 adverse event of pain was reported. No
other Grade 3 or worse adverse events were observed and there were
no reports of any treatment-related serious adverse events
(SAEs).
Analysis of tissue samples from patients treated with pIL-12 EP
showed a gene expression pattern consistent with generation of an
inflammatory response with increased CD8+ TILs (tumor-infiltrating
lymphocytes) and the induction of key immune co-stimulatory
molecules. These findings were corroborated by the results of
preliminary preclinical experiments testing pIL-12 EP in the
B16.F10 mouse melanoma model, which also indicated the presence of
CD8+ TILs (tumor-infiltrating lymphocytes) and the induction of
adaptive resistance mechanisms in distant tumors.
Dr. Pierce said, “We are pleased to see such good concordance
between our findings from patient biopsy samples and the B16.F10
mouse model. This gives us confidence that we can use this
experimental model to deepen our understanding of how ImmunoPulse
re-programs the immune system to drive a systemic anti-cancer
immune response. Taken together, these clinical and preclinical
data provide further evidence for combining this approach with
checkpoint inhibitors such as anti-PD-1.”
Punit Dhillon, President and Chief Executive Officer, added,
“Induction of systemic anti-tumor immune responses in metastatic
melanoma with a local IL-12 therapy, like ImmunoPulse, may provide
an important and convenient therapeutic option for treating this
devastating disease, particularly with other therapies that block
immune checkpoints. In light of this data, we are excited about our
recently announced combination trial of ImmunoPulse IL-12 with
Merck's recently approved PD-1 inhibitor, Keytruda®, in a Phase IIb
study.”
About OncoSec Medical
OncoSec Medical Inc. is a biopharmaceutical company developing
its investigational ImmunoPulse intratumoral cancer immunotherapy.
OncoSec Medical's core technology is designed to
enhance the local delivery and uptake of DNA IL-12 and
other DNA-based immune-targeting agents. Clinical studies of
ImmunoPulse have demonstrated an acceptable safety profile and
preliminary evidence of anti-tumor activity in the treatment of
various skin cancers, as well as the potential to initiate a
systemic immune response without the systemic toxicities associated
with other treatments. OncoSec's lead program evaluating
ImmunoPulse for the treatment of metastatic melanoma is currently
in Phase 2 development, and is being conducted in collaboration
with several prominent academic medical centers. As the company
continues to evaluate ImmunoPulse in its current indications, it is
also focused on identifying and developing new immune-targeting
agents, investigating additional tumor indications, and evaluating
combination-based immunotherapy approaches. For more information,
please visit www.oncosec.com.
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements 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. Some of the
potential risks and uncertainties that could cause actual results
to differ from those predicted include our ability to raise
additional funding, our ability to acquire, develop or
commercialize new products, uncertainties inherent in pre-clinical
studies and clinical trials, unexpected new data, safety and
technical issues, competition, and market conditions. These and
additional risks and uncertainties are more fully described in
OncoSec Medical’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
Medical 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.
Investor Relations:OncoSec Medical Inc.Jordyn Kopin,
855-662-6732investors@oncosec.comorPublic Relations:Dian Griesel
Int’l.Laura Radocaj, 212-825-3210lradocaj@dgicomm.com
OncoSec Medical (NASDAQ:ONCS)
Historical Stock Chart
From Apr 2024 to May 2024
OncoSec Medical (NASDAQ:ONCS)
Historical Stock Chart
From May 2023 to May 2024