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NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ:SLS), a clinical-stage biotech company with a market capitalization of $159 million, announced Thursday that the Independent Data Monitoring Committee (IDMC) has recommended continuing the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) without modifications. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The IDMC completed a pre-specified analysis of the trial and concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct. Wall Street analysts maintain an optimistic outlook, with price targets ranging from $6 to $7.50, suggesting significant potential upside from current levels.
The REGAL trial, which completed enrollment in April 2024 with 126 randomized patients, is evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Study sites in the U.S. and Europe accounted for approximately 75% of enrolled patients, with U.S.-based sites representing the highest enrollment by country.
As a survival-driven study, the final analysis will be triggered once 80 events (deaths) have occurred. According to the company, this threshold has not yet been reached.
The IDMC is an independent group of medical, scientific, and biostatistics experts responsible for reviewing patient safety and efficacy data, as well as monitoring the overall conduct of the REGAL trial.
GPS targets the WT1 protein, which is present in various tumor types. The company is also developing SLS009 (tambiciclib), a CDK9 inhibitor for cancer treatment.
The information in this article is based on a company press release statement.
In other recent news, SELLAS Life Sciences Group, Inc. has presented promising preclinical data for its drug SLS009 at the American Society of Clinical Oncology Annual Meeting. The data highlighted the drug’s efficacy in colorectal cancer cell lines with ASXL1 mutations, showing significant anti-proliferative activity. In addition, SELLAS has initiated treatment for the first pediatric patient in a Phase 2 trial of SLS009 for relapsed/refractory acute myeloid leukemia, focusing on patients with limited treatment options. In other developments, SELLAS will be added to the Russell 3000 and Russell 2000 Indexes as part of the 2025 Russell indexes annual reconstitution. The company has also expanded its Scientific Advisory Board with the addition of experts Philip C. Amrein, MD, and Alex Kentsis, MD, PhD, and more recently, Linghua Wang, MD, PhD, from MD Anderson Cancer Center. These appointments reflect SELLAS’s preparation for significant milestones in its clinical programs.
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