SAN DIEGO, April 16, 2018 /PRNewswire/ -- OncoSec Medical
Incorporated (OncoSec) (NASDAQ: ONCS), a company developing
intratumoral cancer immunotherapies, today provided highlights from
its Research Reception held on Sunday, April
15, 2018, during the American Association of Cancer Research
(AACR) Annual Meeting 2018.
The Research Reception was organized to provide industry experts
gathered at the AACR with a comprehensive overview of OncoSec's
ongoing and anticipated clinical programs involving
ImmunoPulse® IL-12 (or
Intratumoral tavo-EP) in metastatic melanoma and
triple-negative breast cancer (TNBC), including an overview of a
poster presented at AACR regarding a Phase 1 pilot study of
ImmunoPulse IL-12 in TNBC ("Intratumoral
plasmid IL-12 and electroporation in pre-treated inoperable
locally advanced or recurrent triple-negative breast cancer
(TNBC)" - Poster 055 / Abstract CT022).
ImmunoPulse IL-12 is currently being used in several ongoing
clinical trials, with the technology demonstrating evidence of
anti-tumor activity in the treatment of various solid tumors, the
potential to initiate a systemic immune response, and a favorable
safety profile. ImmunoPulse IL-12 combines intratumoral plasmid
IL-12 with electroporation to produce a controlled, localized
expression of IL-12 in the tumor microenvironment, which in turn,
enables the immune system to target and attack tumors throughout
the body.
The full webcast and presentation slides from the Research
Reception can be accessed via OncoSec's website:
http://www.oncosec.com.
The following is a recap of key highlights from the event:
Melanoma Data Update: OMS-I100 Monotherapy Study &
OMS-I102 Pembrolizumab Combination Study
Led by
Alain Algazi, MD of the UCSF Helen
Diller Family Comprehensive Cancer Center, the first presentation
provided data from the OMS-I100 Phase 2 clinical trial, which
demonstrated that ImmunoPulse IL-12 delivered as a monotherapy
promoted innate and adaptive immune responses, importantly driving
increased CD8+ TIL frequency.
- Updated clinical data from the OMS-I100 study demonstrated
that, in addition to peripheral immune responses, regression of
distal, non-treated lesions were observed on average in 45% of the
patients
- Also, the treatment-related reshaping of the tumor
microenvironment points to amplification of the IFN-γ/IL-12
feedforward loop, which in addition to supporting anti-tumor
immunity, triggers adaptive immune resistance (PD-L1 expression)
and provides the basis for a combination with IL-12 and anti-PD-1
therapy
- Updated data from the OMS-I102 Phase 2 clinical trial
(ImmunoPulse IL-12 in combination with pembrolizumab) demonstrated
a 57% progression free survival (PFS) rate at 21 months with 100%
(11/11) duration of response and median PFS/OS not yet reached
OMS-I140 Protocol; Review of Intratumoral IL-12 Data in TNBC
Presented at AACR
Led by Melinda
Telli, MD of the Stanford
University Medical Center, the following presentation
provided a review of the OMS-I140 Phase 1 pilot study of
ImmunoPulse IL-12 in TNBC, including an analysis of initial
findings from the study, which were presented as a poster during
AACR. The Phase 1 pilot study was designed to determine
whether intratumoral plasmid IL-12 with electroporation
(ImmunoPulse IL-12) would elicit a pro-inflammatory molecular and
histological signature in treated as well untreated sites.
Following administration of ImmunoPulse IL-12 on Days 1, 5 and 8 of
a single 28-day cycle, data was obtained from five patients of the
10-patient study.
- Treatment-related increase in CD8+ TIL density
was observed by intratumoral chromogenic staining in 2 of 5 patient
tumors (1 treated /1 untreated tumor)
- NanoString analysis suggests that 1 cycle of Intratumoral
tavo-EP did not globally impact intratumoral immune-related gene
expression
- Evidence of a treatment-related productive systemic immune
response was seen in reduced gMDSCs and increased SLECs in the
peripheral blood
- Reported treatment-related adverse events included transient
pain associated with electroporation and fatigue (both grade
1)
- These results suggest that Intratumoral tavo-EP is a safe and
tolerable TIL-stimulating therapy of skin and subcutaneous TNBC
tumors
- Further study of this therapy in combination with anti-PD-1
antibody therapy is warranted
OMS-I141 Protocol; Upcoming Anti-PD-1 Combination Clinical
Trial in TNBC
A presentation given by Pamela Munster, MD of the UCSF Helen Diller
Family Comprehensive Cancer Center, provided a review of OncoSec's
proposed Phase 2 trial in TNBC involving a combination of
ImmunoPulse IL-12 (intratumoral tavo-EP) and an anti-PD-1 antibody
therapy. The future Phase 2 trial will be a Simon 2-stage minimax
design, non-comparative, open-label, single-arm, multicenter study
of ImmunoPulse IL-12 plus an anti-PD-1 antibody therapy.
- The study is expected to enroll approximately 25 patients (15
in Stage 1, and, if appropriate, 10 in Stage 2) with TNBC and
electroporation accessible cutaneous / subcutaneous tumors
- The proposed primary endpoint is to assess efficacy as measured
by objective response rate (ORR) by independent central review
(ICR) based on Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1 of intratumoral tavo-EP in combination with an
anti-PD-1 antibody therapy in subjects with inoperable locally
advanced or metastatic TNBC
- OncoSec expects to initiate this proposed study in
2018
PISCES/KEYNOTE-695 Operational Update
Led by
OncoSec's Chief Clinical and Regulatory Officer, Sharron Gargosky, PhD, the final presentation
offered an operational assessment of PISCES/KEYNOTE-695, a global,
multicenter Phase 2b, open-label
trial of ImmunoPulse IL-12 in combination with pembrolizumab in
patients with stage III/IV melanoma who have progressed or are
progressing on either pembrolizumab or nivolumab
treatment. OncoSec expects to report preliminary data at an
upcoming medical meeting in 2018.
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.
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:
Janine McCargo / David
Schemelia
Tiberend Strategic Advisors, Inc.
Phone: 212-827-0020
jmccargo@tiberend.com dschemelia@tiberend.com
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SOURCE OncoSec Medical Incorporated