PENNINGTON, N.J. and
SAN DIEGO, April 14, 2021 /PRNewswire/ -- OncoSec Medical
Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a
biotechnology company focused on cytokine-based intratumoral
immunotherapies, today announced that it has received authorization
to CE mark its proprietary next generation go-to-market gene
delivery device, GenPulse™, a part of the OncoSec Medical System
(OMS) electroporation device platform for use in solid tumors. The
CE mark certification augments the Notified Body certification to
the International Organization for Standardization's (ISO) 13485
standard for the design, development, manufacture and distribution
of electroporation devices, which is renewed annually, subject to a
successful audit. The GenPulse is the gene electrotransfer device
which OncoSec plans to deploy commercially, both in the U.S. and
the European Union (EU).
"This CE certification is an essential regulatory milestone on
OncoSec's road to commercialization in Europe," said Robert
Ashworth, Senior Vice President, Regulatory Quality and CMC
at OncoSec. "The CE mark on our proprietary GenPulse generator
represents the culmination of years of work and demonstrates that
OncoSec has the capability to manufacture and develop a device that
meets performance, quality and safety requirements in the
EU."
A CE mark indicates the OMS electroporation device complies with
Directives of the European Commission (EC) and therefore can be
marketed within the 31-nation European Economic Area (EEA) and
Switzerland. This OMS
electroporation device applies short electric impulses to a tumor,
causing pores to open in the membrane of cancer cells,
significantly increasing the uptake of anti-cancer agents into
these cells. The CE mark certification involved a comprehensive
audit of the company's quality system, as well as thorough
evaluation and testing of the OMS electroporation device to assure
it performs safely and as designed.
About OncoSec Medical Incorporated
OncoSec Medical Incorporated (the "Company," "OncoSec," "we" or
"our") is a biotechnology company focused on developing
cytokine-based intratumoral immunotherapies to stimulate the body's
immune system to target and attack cancer. OncoSec's lead
immunotherapy investigational product candidate – TAVO™
(tavokinogene telseplasmid) – enables the intratumoral delivery of
DNA-based interleukin-12 (IL-12), a naturally occurring protein
with immune-stimulating functions. The technology, which employs
electroporation, is designed to produce a controlled, localized
expression of IL-12 in the tumor microenvironment, enabling the
immune system to target and attack tumors throughout the body.
OncoSec has built a deep and diverse clinical pipeline utilizing
TAVO™ as a potential treatment for multiple cancer indications
either as a monotherapy or in combination with leading checkpoint
inhibitors; with the latter potentially enabling OncoSec to address
a great unmet medical need in oncology: anti-PD-1 non-responders.
Results from recently completed clinical studies of TAVO™ have
demonstrated a local immune response, and subsequently, a systemic
effect as either a monotherapy or combination treatment approach
along with an acceptable safety profile, warranting further
development. In addition to TAVO™, OncoSec is identifying and
developing new DNA-encoded therapeutic candidates and tumor
indications for use with its new Visceral Lesion Applicator (VLA),
to target deep visceral lesions, such as liver, lung or pancreatic
lesions. For more information, please visit www.oncosec.com.
GenPulse™ and TAVO™ are trademarks of OncoSec Medical
Incorporated.
Risk Factors and Forward-Looking Statements
This release, as well as other information provided from time to
time by the Company or its employees, may contain forward-looking
statements that involve a number of risks and uncertainties that
could cause actual results to differ materially from those
anticipated in the forward-looking statements. Forward-looking
statements provide the Company's current beliefs, expectations and
intentions regarding future events and involve risks, uncertainties
(some of which are beyond the Company's control) and assumptions.
For those statements, we claim the protection of the safe harbor
for forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. You can identify forward-looking
statements by the fact that they do not relate strictly to
historical or current facts. These statements may include words
such as "anticipate," "believe," "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "should," "will" and "would"
and similar expressions (including the negative of these terms).
Although we believe that expectations reflected in the forward-
looking statements are reasonable, we cannot guarantee future
results, levels of activity, performance or achievements. The
Company intends these forward-looking statements to speak only at
the time they are published on or as otherwise specified, and does
not undertake to update or revise these statements as more
information becomes available, except as required under federal
securities laws and the rules and regulations of the Securities
Exchange Commission ("SEC"). In particular, you should be aware
that the success and timing of our clinical trials, including
safety and efficacy of our product candidates, patient accrual,
unexpected or expected safety events, the impact of COVID-19 on the
supply of our candidates or the initiation or completion of
clinical trials and the usability of data generated from our trials
may differ and may not meet our estimated timelines. Please refer
to the risk factors and other cautionary statements provided in the
Company's Annual Report on Form 10-K for the fiscal year ended
July 31, 2019 and subsequent periodic
and current reports filed with the SEC (each of which can be found
at the SEC's website www.sec.gov), as well as other factors
described from time to time in the Company's filings with the
SEC.
Company Contact
Brian
Leuthner
Chief Operating Officer
investors@oncosec.com
Media Contact
Patrick
Bursey
LifeSci Communications
+1-646-970-4688
pbursey@lifescicomms.com
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SOURCE OncoSec Medical Incorporated