SELLAS Life Sciences Launches Expanded Access Program for Galinpepimut-S
April 26 2022 - 8:30AM
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the
“Company”), a late-stage clinical biopharmaceutical company focused
on the development of novel therapies for a broad range of cancer
indications, today announced that the Company has launched a
Pre-Approval Access/Expanded Access Program (“EAP”) with SELLAS’
lead asset, GPS, for treating patients suffering from acute myeloid
leukemia (AML).
GPS is an immunotherapeutic that targets the
Wilms Tumor 1 (WT1) protein. The Company is currently testing GPS
as a monotherapy in a pivotal Phase 3 clinical trial (the REGAL
trial) in patients with AML who have achieved second complete
remission, as well as in combination with PD1 inhibitors in earlier
stage clinical trials.
“After receiving multiple requests from
physicians who have been following GPS and its results to date, it
became clear, particularly under the 21st Century Cures Act, that
we needed to initiate an EAP quickly to help patients around the
world with AML, an aggressive form of cancer that progresses
rapidly without the proper treatment,” said Angelos Stergiou, MD,
ScD. h.c., President and CEO, SELLAS. “SELLAS is firmly committed
to its mission to improve clinical outcomes for these patients and
their families who want to consider all possible therapeutic
options, as well as ensuring that we are bringing a new, safe and
potentially effective treatment option to physicians and patients
in need.”
For more information on the GPS EAP, please
visit the PIPELINE page at www.sellaslifesciences.com. If you are a
physician who would like to request GPS access for your patient,
please email ExpandedAccessRequests@sellaslife.com.
About SELLAS Life Sciences Group,
Inc. SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a
late-stage clinical biopharmaceutical company focused on the
development of novel therapeutics for a broad range of cancer
indications. SELLAS’ lead product candidate, GPS, is licensed from
Memorial Sloan Kettering Cancer Center and targets the WT1 protein,
which is present in an array of tumor types. GPS has potential as a
monotherapy or in combination with other therapies to address a
broad spectrum of hematologic malignancies and solid tumor
indications. The Company is also developing GFH009, a small
molecule, highly selective CDK9 inhibitor, which is licensed from
GenFleet Therapeutics (Shanghai), Inc., for all therapeutic and
diagnostic uses in the world outside of Greater China.
For more information on SELLAS, please
visit www.sellaslifesciences.com.
Forward-Looking Statements This
press release contains forward-looking statements. All statements
other than statements of historical facts are “forward-looking
statements,” including those relating to future events. In some
cases, forward-looking statements can be identified by terminology
such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,”
“should,” “project,” “believe,” “estimate,” “predict,” “potential,”
“intend,” or “continue” and other words or terms of similar
meaning. These statements include, without limitation, statements
related to the clinical development of GPS, including an expanded
access program for GPS with AML patients. These forward-looking
statements are based on current plans, objectives, estimates,
expectations, and intentions, and inherently involve significant
risks and uncertainties. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the COVID-19 pandemic and its impact
on the Company’s clinical plans, risks and uncertainties associated
with oncology product development and clinical success thereof, the
uncertainty of regulatory approval, and other risks and
uncertainties affecting SELLAS and its development programs as set
forth under the caption “Risk Factors” in SELLAS’ Annual Report on
Form 10-K filed on March 31, 2022 and in its other SEC filings.
Other risks and uncertainties of which SELLAS is not currently
aware may also affect SELLAS’ forward-looking statements and may
cause actual results and the timing of events to differ materially
from those anticipated. The forward-looking statements herein are
made only as of the date hereof. SELLAS undertakes no obligation to
update or supplement any forward-looking statements to reflect
actual results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
Investor Contact Allison Soss
KCSA Strategic Communications Email: SELLAS@kcsa.com Phone:
212.896.1267
Media Contacts Raquel Cona /
Michaela Fawcett KCSA Strategic Communications Email:
SELLAS@kcsa.com Phone: 212.896.1276
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