SAN DIEGO, Dec. 14, 2017 /PRNewswire/ -- OncoSec Medical
Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company
developing intratumoral cancer immunotherapies, today announced the
initiation of patient dosing in PISCES/KEYNOTE-695, the company's
global, multi-center, registration-directed open-label Phase
2b clinical trial. The trial will
evaluate the combination of ImmunoPulse® IL-12 (intratumoral pIL-12
[tavokinogene telseplasmid or "tavo"] with electroporation), and
pembrolizumab in patients with unresectable metastatic melanoma who
have progressed or are progressing on an anti-PD-1 therapy.
"There remains a significant unmet medical need in oncology for
patients in whom the existing PD-1 therapies do not work. Based on
the encouraging data we presented at SITC, we believe the
combination of ImmunoPulse IL-12 and pembrolizumab may offer a
differentiated approach to reshaping the tumor microenvironment by
converting immunologically cold tumors to hot," said Sharron
Gargosky, Chief Clinical and Regulatory Officer of OncoSec. "We
look forward to the continued advancement of this trial and to
sharing data in 2018."
The Phase 2b, multicenter study of
intratumoral tavo with electroporation in combination with
intravenous pembrolizumab will enroll approximately 48 patients
with a 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).
The Company's prior Phase 2 OMS I-102 combination study of
ImmunoPulse® IL-12 and pembrolizumab in 22 patients unlikely to
respond to anti-PD-1 therapy demonstrated a 50% best overall
response rate and a 41% complete response rate. In addition, the
trial showed a 57% progression free survival (PFS) rate at 15
months (median PFS not yet reached) and 100% (11/11) duration of
response. In clinical studies to date, intratumoral tavo has
demonstrated a favorable safety profile and has been well
tolerated.
PISCES/KEYNOTE-695 is the second combination study conducted
with pembrolizumab and, if successful, could form
the basis for a BLA under the accelerated approval
pathway.
To learn more about the trial, visit www.oncosec.com.
Additional details can also be found at www.clinicaltrials.gov via
NCT03132675.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in skin cells
called melanocytes. As the cancer progresses, melanoma becomes more
difficult to treat once it spreads beyond the skin, such as the
lymphatic system (metastatic disease). Given its occurrence in
young individuals, the potential years of life lost to melanoma can
be higher when compared with other cancers. Although melanoma is a
rare form of skin cancer, it accounts for over 75% of skin cancer
deaths. The American Cancer Society estimates that approximately
87,000 new melanoma cases and 10,000 deaths from the disease will
occur in the United States in
2017. Additionally, the World Health Organization estimates that
approximately 132,000 new cases of melanoma are diagnosed around
the world every year.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination
Electroporation Study)/KEYNOTE-695
PISCES/KEYNOTE-695 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).
To learn more about the trial, visit www.oncosec.com. Additional
details can also be found at www.clinicaltrials.gov via
NCT03132675.
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, 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. In some cases, you can identify
forward-looking statements by terminology such as "may", "should",
"expects", "plans", "anticipates", "believes", "estimates",
"predicts", "potential" or "continue" or the negative of these
terms or other comparable terminology.
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: the status, progress and results of clinical programs;
ability to obtain regulatory approvals for, and the level of market
opportunity for, OncoSec's product candidates; OncoSec's business
plans, strategies and objectives, including plans to pursue
collaboration, licensing or other similar arrangements or
transactions; expectations regarding OncoSec's liquidity and
performance, including expense levels, sources of capital and
ability to maintain operations as a going concern; the competitive
landscape of OncoSec's industry; and general market, economic and
political conditions; and the other factors discussed in OncoSec's
filings with the Securities and Exchange Commission, including its
annual report on Form 10-K for the year ended July 31, 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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SOURCE OncoSec Medical Incorporated