SAN DIEGO, Feb. 27, 2017
/PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec")
(NASDAQ: ONCS), a company developing DNA-based intratumoral cancer
immunotherapies, received Fast Track designation from the U.S. Food
and Drug Administration (FDA) for its ImmunoPulse® IL-12, a
potentially first-in-class, Intratumoral anti-cancer gene therapy
that expresses interleukin-12 (IL-12) for the treatment of
metastatic melanoma, following progression on pembrolizumab or
nivolumab.
"With the number of melanoma patients now being treated with
either pembrolizumab or nivolumab in either the first- or
second-line settings, there will be an increasing number of
patients who will not respond to therapy. Thus, there is a clear
need for treatments that can rescue these patients and help them
benefit from these immunotherapies," said Punit Dhillon, OncoSec President and CEO. "With
the recent presentation of our interim data from our ongoing
combination study with pembrolizumab in patients predicted not to
respond to single-agent anti-PD-1 therapy, we are increasingly
confident in ImmunoPulse® IL-12 to potentially convert 'cold'
tumors to 'hot' tumors to effectively and safely improve the
response rates of these patients."
"This Fast Track designation by the FDA serves as an additional
validation for OncoSec's clinical development program," said
Sharron Gargosky, Ph.D., Chief Clinical and Regulatory Officer. "As
we launch our upcoming Phase 2b PISCES clinical trial, we look
forward to collaborating closely with the FDA at this important
stage of our clinical program."
The PISCES (Anti-PD-1 IL-12 Stage III/IV
Combination Electroporation Study) will
be a Phase 2b, Simon 2-stage, non-comparative, open-label,
single-arm, multicenter study of ImmunoPulse® IL-12 (intratumoral
pIL-12 plus electroporation) in combination with an intravenous
anti-PD-1 antibody in patients with histological diagnosis of
melanoma with progressive locally advanced or metastatic disease
defined as Stage III or Stage IV. Eligible patients will be those
with Stage III/IV metastatic melanoma who are progressing or have
progressed according to RECIST v1.1 guidelines on, or within, 24
weeks of receiving approved anti-PD-1 antibodies on either
pembrolizumab or nivolumab treatment (either as monotherapy or in
combination with another approved checkpoint inhibitor). The
primary endpoint for this registration-directed trial will be
overall response rate (ORR) at 24 weeks with secondary endpoints of
best overall response rate (BORR), duration of response (DOR),
median progression-free survival (PFS) and overall survival (OS).
This clinical trial is planned to initiate in the first half of
2017.
The FDA established the Fast Track program to facilitate the
development and expedite the review of new drugs that are intended
to treat serious or life-threatening conditions, and demonstrate
the potential to address unmet medical needs. Drugs that receive
this designation benefit from more frequent communications and
meetings with the FDA, to review the drug's development plan
including the design of the proposed clinical trials, use of
biomarkers, and the extent of data needed for approval. Fast
Track designated drugs may qualify for expedited FDA review, and a
rolling Biologics License Application (BLA), if certain criteria
are met.
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. In Phase I and II clinical trials,
ImmunoPulse® IL-12 has demonstrated a favorable
safety profile and evidence of anti-tumor activity in the treatment
of various solid tumors as well as a systemic immune response.
OncoSec's lead program, ImmunoPulse® IL-12, is currently in
clinical development for several indications, including 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 non-responsive to anti-PD-1/PD-L1
therapies. In addition to ImmunoPulse® IL-12, 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.
CONTACTS:
Investor Relations:
OncoSec Medical Incorporated
Phone: 855-662-6732
investors@oncosec.com
Media:
Laura Radocaj
DGI Comm
Phone: 212-825-3210
media@oncosec.com
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SOURCE OncoSec Medical Incorporated