SAN DIEGO, Oct. 19, 2017 /PRNewswire/ -- OncoSec
Medical Incorporated ("OncoSec" or "Company") (NASDAQ:ONCS), a
company developing DNA-based intratumoral cancer immunotherapies,
today announced updated Phase 2 clinical and immune monitoring data
from patients treated with its investigational therapy,
ImmunoPulse® IL-12 as a monotherapy versus the combination
of ImmunoPulse IL-12 and the approved anti-PD-1 therapy
pembrolizumab. These data were presented today in an oral
presentation at the 2017 9th World Congress of Melanoma – A Joint
Meeting with the Society for Melanoma Research, and continue to
support the rationale for the Company's recently initiated global,
open-label, Phase 2b registration directed trial,
PISCES/KEYNOTE-695.
The Phase 2 OMS-I100 monotherapy and Phase 2 OMS-I102
combination with pembrolizumab studies included 51 and
22* patients, respectively, with metastatic melanoma.
The combination study patients were selected based on their
baseline biomarker data, which predicted that patients would not
respond to anti-PD-1 therapy. Monotherapy patients were treated
with ImmunoPulse IL-12 alone and patients in the combination study
also received pembrolizumab every 3 weeks per protocol. Fewer than
10% of patients in both studies reported treatment related serious
adverse events (9.8% in the monotherapy and 8.7% in the combination
studies). Data also demonstrate that ImmunoPulse IL-12 can trigger
key immunologic events driving a cellular response leading to an
inflamed tumor with increased TIL frequency whether as a
monotherapy or combined with pembrolizumab, converting "cold"
tumors to "hot", which were further enhanced with the addition of
an anti-PD1 antibody.
*Includes one CR with
non-evaluable RECIST lesions
|
Key Findings
OMS-I102 Combination with Pembrolizumab
50% (11/22) BORR observed at 24 weeks (42.9% [9/21] achieved
RECIST v1.1 BORR).
41% (9/22) complete responders (CR), 9% (2/22) partial
responders (PR), and 9% (2/22) stable disease (SD) for a total
disease control rate of 59% (38.1% [8/21] achieved RECIST v1.1
durable CR).
Data demonstrate that the combination of ImmunoPulse IL-12 and
pembrolizumab prime a coordinated innate and adaptive immune
response, suggesting a synergistic relationship with anti-PD-1.
OMS-I100 Monotherapy
25-34.6% best overall response rate (BORR) by a modified "skin"
RECIST.
Favorable safety profile (no life threatening or grade 4
AE).
In patients (n=26) treated with ImmunoPulse IL-12 on a 90-day
cycle, there were 19.2% (5/26) complete responders (CR), 15.4%
(4/26) partial responders (PR), and 34.6% (9/26) stable disease
(SD) for a total disease control rate of 69.2%.
In the protocol addendum where patients (n=20) were treated with
ImmunoPulse IL-12 on a 6-week cycle, there were 0 complete
responders (CR), 25% (5/20) partial responders (PR), and 40% (8/20)
stable disease (SD) for a total disease control rate of 65%.
"We are encouraged by the data from these analyses, which
continue to show that ImmunoPulse IL-12 can prime the immune system
to help improve patient response to anti-PD-1," said Dr.
Alain Algazi, Lead Trial
Investigator, Associate Professor, Department of Medicine
(Hematology/Oncology), at the University of
California San Francisco (UCSF) Helen Diller Family
Comprehensive Cancer Center. "The complete response rates observed
in the Phase 2 study assessing the combination of ImmunoPulse IL-12
and pembrolizumab in the predicted anti-PD-1 non-responder patient
population provide compelling early evidence that the combination
could lead to a clinically meaningful impact on patient
outcomes."
"Collectively, these study findings reinforce the combination of
ImmunoPulse IL-12 and pembrolizumab to address a significant unmet
medical need in melanoma patients who are unlikely to respond to
anti-PD-1 therapies," said Punit
Dhillon, CEO and President of OncoSec. "We look forward to
presenting additional data from our ongoing Phase 2 combination
study at the upcoming 2017 Society for Immunotherapy of Cancer
Annual Meeting, in addition to our global, open-label, registration
directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we
anticipate reporting initial data in mid-2018."
The full-text abstract is available and can be viewed on the
World Melanoma Congress – Joint Meeting with the Society of
Melanoma Research website at https://worldmelanoma2017.com/. The
presentation is available in the Publications section of OncoSec's
website.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination
Electroporation Study)
PISCES is a global, multicenter phase 2b, open-label trial of
intratumoral plasma encoded IL-12 (tavokinogene telseplasmid or
"tavo") delivered by electroporation in combination with
intravenous pembrolizumab in patients with stage III/IV melanoma
who have progressed or are progressing on either pembrolizumab or
nivolumab treatment. The Simon 2-stage study of intratumoral tavo
plus electroporation in combination with pembrolizumab will enroll
approximately 48 patients with histological diagnosis of melanoma
with progressive locally advanced or metastatic disease defined as
Stage III or Stage IV. The primary endpoint will be the Best
Overall Response Rate (BORR).
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 IL-12 (tavokinogene telseplasmid
[pIL-12] 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, including statements about OncoSec's business strategies,
including advancement of its lead melanoma program and its broader
clinical portfolio and plans to pursue collaborations with industry
partners, as well as the potential contributions and impact of new
directors on these strategies. 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 OncoSec's 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 substantial time, costs and
unpredictability of such studies and trials, the ability to enroll
patients in clinical trials and the risk of adverse events;
unexpected new data, safety and technical issues; OncoSec's 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, including its quarterly report
on Form 10-Q for the quarter ended April 30,
2017.
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:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
Media Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
media@oncosec.com
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