OncoSec Medical Presents Positive Phase 2 Interim Data Evaluating ImmunoPulse in Melanoma
June 02 2014 - 9:31AM
Business Wire
Data Presented at 2014 ASCO Annual Meeting
Suggest ImmunoPulse is Well-Tolerated and Has a Systemic Anti-Tumor
Response
OncoSec Medical Inc. (OTCQB: ONCS), a company developing
its ImmunoPulse DNA-based intratumoral cancer immunotherapy,
announced interim data from its Phase 2 melanoma study at the
American Society of Clinical Oncology’s (ASCO) 50th Annual Meeting
in Chicago. The abstract, titled “Systemic anti-tumor effect and
clinical response in a Phase 2 trial of intratumoral
electroporation of plasmid interleukin-12 in patients with advanced
melanoma” (ASCO Abstract #9025), was presented by Adil Daud, M.D.,
OncoSec’s Chief Clinical Strategist and Principal Investigator of
the Phase 2 melanoma study, and selected for discussion during a
poster highlights session for melanoma/skin cancers led by Axel
Hauschild, M.D., Ph.D.
Data from the multicenter, open-label, single-arm study
confirmed the safety of OncoSec’s lead product candidate,
ImmunoPulse, which delivers the anti-tumor agent pIL-12 directly
into the tumor via in-vivo electroporation (EP), with no
treatment-related serious adverse events or deaths having been
reported. Regression of treated and non-treated tumors suggests
successful induction of systemic anti-tumor response.
To date, 30 patients have been enrolled and have received at
least one cycle of treatment. At the time of this interim analysis,
28 patients were evaluable for objective response rate (ORR) at
24-week primary time point. Best ORR was evaluated per modified
RECIST1.1 criteria, and provided in Table 1 below.
Table 1: Best ORR at 24 Weeks of First Treatment (Modified
RECIST)
Number of Evaluable Patients Objective
Response (%) Complete Response (%) 28
9/28 (32%) 3/28 (11%)
In addition to best overall response, an assessment of best
local response in treated lesions was conducted (Table 2). Complete
response was defined as complete regression of a treated lesion.
Partial response was defined as >30 percent reduction in the
longest diameter of the tumor, while stable disease was defined as
≤30 percent reduction and <20 percent increase in the longest
diameter of the tumor.
Table 2: Treated Lesion Best Local Response
Number of Evaluable Treated Lesions Stable
Disease (%) Partial Response (%)
Complete Response (%) 85 26/85 (31%)
7/85 (8%) 38/85 (45%)
Importantly, intratumoral treatment with IL-12 EP resulted in
the development of a systemic anti-tumor effect in the majority of
patients. Twenty-two of the enrolled patients presented with
baseline lesions that were left untreated in order to evaluate the
induction of a systemic response. Regression was documented in at
least one non-injected tumor in 59 percent (13/22) of patients
(Table 3). These results suggest that intratumoral therapy with
IL-12 can induce systemic anti-tumor responses while avoiding the
toxicities observed with systemic recombinant IL-12 therapy.
Table 3: Systemic Anti-tumor Response (Untreated
lesions)
Number of Evaluable Patients Response (at
least 30% decrease) in at least 1 untreated lesion 22
13/22 (59%)
Correlative data were also presented, including gene expression
in a subset of eight patients, where adequate paired pre- and
post-treatment biopsy samples were available. Utilizing
NanoString®’s nCounter technology, a focused analysis of
immunomodulatory cell types and pathways supported the hypothesis
that IL-12 electroporation leads to induction of interferon- and
downstream interferon--inducible genes, including key modulators
of antigen presentation and processing machinery and chemokines.
Additional genes of interest were also up-regulated, including
PD-1, PD-L1 and T cell markers, confirming the Phase 1 data,
indicating that treatment results in T cell infiltration.
OncoSec’s Chief Medical Officer, Robert H. Pierce, M.D.,
commented: “Taken together, these data—the systemic clinical
responses, the gene expression pattern in the treated lesions in
patients and our analysis of treated and untreated tumors in B16
mouse model—form a coherent picture of IL-12’s mechanism of action
as a potent enhancer of tumor immunogenicity. In summary,
intratumoral IL-12 appears to ‘de-cloak’ the tumor, allowing the
immune system to see the tumor as ‘foreign’ and generate the CD8 T
cells needed to mount an attack. These findings are incredibly
important given the emerging understanding that a prerequisite for
response to T cell checkpoint therapies such as anti-PD-1 mAbs is
the presence of the PD-1+ CD8 T cells.”
“To establish our leadership, we have been strongly investing in
our R&D infrastructure and these efforts are paying off, and we
expect OncoSec to be the most innovative and scientifically driven
intratumoral immunotherapy company in the industry” said Punit
Dhillon, President and CEO of OncoSec. “The more we understand
IL-12’s mechanism of action, the better positioned we are to expand
our development into other targets as well as drive rational
combinations in the clinic, and that’s OncoSec’s development path
forward.”
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing
its ImmunoPulse DNA-based intratumoral cancer immunotherapy.
OncoSec Medical's core technology leverages a proprietary
electroporation platform to enhance the local delivery
and uptake of IL-12 and other DNA-based immune-modulating 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 for
a systemic immune response without the systemic toxicities
associated with other treatments. OncoSec's clinical programs
currently include three Phase 2 trials targeting metastatic
melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma
respectively
(http://clinicaltrials.gov/ct2/results?term=oncosec&Search=Search).
As the company continues to evaluate ImmunoPulse in these
indications, it is also investigating additional indications and
combination-based 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.Veronica Vallejo, CFO,
855-662-6732 investors@oncosec.com
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