SELLAS Life Sciences Launches Expanded Access Program for Galinpepimut-S
SELLAS Life Sciences Group (NASDAQ: SLS) has launched a Pre-Approval Access Program for its lead immunotherapy asset, Galinpepimut-S (GPS), targeting patients with Acute Myeloid Leukemia (AML). This initiative responds to demand from physicians under the 21st Century Cures Act. GPS, which targets the WT1 protein, is currently in pivotal Phase 3 trials and has shown promise as a monotherapy and in combination with PD1 inhibitors. SELLAS aims to improve outcomes for AML patients seeking novel therapeutic options.
- Launch of Pre-Approval Access Program for GPS to treat AML patients.
- GPS is currently in pivotal Phase 3 clinical trials, indicating advanced development stage.
- Positive feedback from physicians requesting access to GPS for their patients.
- None.
Physicians To Have Pre-Approval/Expanded Access to Galinpepimut-S (GPS) for Treatment of Patients with Acute Myeloid Leukemia (AML)
NEW YORK, April 26, 2022 (GLOBE NEWSWIRE) -- 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
FAQ
What is the purpose of SELLAS Life Sciences Group's Pre-Approval Access Program for GPS?
How is Galinpepimut-S (GPS) relevant to Acute Myeloid Leukemia (AML)?
What is the significance of the 21st Century Cures Act for SELLAS Life Sciences Group?
What phase are the clinical trials for GPS currently in?
What type of cancer does Galinpepimut-S (GPS) target?
