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NEW YORK, May 25, 2023 (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 a trial in progress poster for the Phase 3 REGAL study of galinpepimut-S (GPS) in acute myeloid leukemia (AML) will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6, 2023 in Chicago.
“We are pleased to present an overview of our ongoing Phase 3 REGAL registrational study at the 2023 ASCO meeting,” said Dragan Cicic, MD, Senior Vice President, Head of Clinical Development of SELLAS. “We are proud of our continued advancement of GPS as a novel treatment for patients with AML in need of better therapies. Our independent data monitoring committee will meet again in Q3, and we currently expect the interim analysis for our Phase 3 REGAL study by the end of this year or early 2024. We have agreement with the FDA on all of our study parameters, including the biostatistical design and relevant hazard ratios and assumptions, for the interim and final analyses. We are grateful to all of our dedicated research physicians, study nurses and participating patients and families in the REGAL study.”
Abstract: TPS7074 Poster Bd: 203b
Abstract Title: A randomized, open-label study of the efficacy and safety of galinpepimut-S (GPS) maintenance monotherapy compared to investigator’s choice of best available therapy (BAT) in patients with acute myeloid leukemia (AML) who have achieved complete remission (CR) after second-line salvage therapy
Clinical Trial Registration Number: NCT04229979
Presenter: Omer Jamy, M.D., Principal Investigator of REGAL study at University of Alabama Birmingham
Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Date and Time: Monday, June 5, 2023, 9:00 AM – 12:00 PM EST
The poster will be available on both the ASCO and SELLAS websites following the session.
About SELLAS Life Sciences Group, Inc.
SELLAS 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 and 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.
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 GPS clinical development program. 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 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 16, 2023 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.
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