SELLAS Life Sciences Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned
SELLAS Life Sciences Group (NASDAQ: SLS) reported a positive review from the Independent Data Monitoring Committee (IDMC) of its ongoing Phase 3 REGAL clinical trial for galinpepimut-S (GPS) targeting acute myeloid leukemia (AML). The IDMC assessed unblinded data and recommended the trial's continuation without modifications, also endorsing the addition of clinical sites in China. This milestone is critical as SELLAS aims for interim analysis by late 2023 or early 2024. The REGAL trial evaluates overall survival in AML patients who achieved complete remission after second-line salvage therapy. Galinpepimut-S is designed to target the WT1 protein found in various tumors, and is being developed as both monotherapy and in combination with other therapies.
- IDMC recommended continuation of REGAL trial without modifications.
- Addition of clinical sites in China expected to enhance trial reach.
- Interim analysis anticipated by late 2023 or early 2024.
- None.
Next IDMC Meeting Scheduled for Q3 2023
REGAL on Track for Interim Analysis by Late 2023/Early 2024
NEW YORK, April 18, 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 a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). The Independent Data Monitoring Committee (IDMC) performed a routine, prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC has further recommended to meet again within Q3 2023 and endorsed all clinical trial initiatives SELLAS has undertaken to advance GPS in the REGAL study, including the addition of clinical sites in China.
“This positive IDMC review marks another significant milestone in GPS development and builds on the favorable profile of our study drug, galinpepimut-S,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Enrollment continues in our global Phase 3 REGAL registrational study, which currently remains on track for interim analysis by the end of 2023 or early 2024.”
REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews for safety, efficacy, and futility in addition to the interim and final analyses.
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.
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 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.
Investor Contact
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
SELLAS@lifesciadvisors.com
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