SELLAS Life Sciences Announces Presentation of Phase 2 Data of SLS009 in Combination with Azacitidine and Venetoclax in Relapsed/Refractory AML with MDS-Related Changes (AML-MR) at the 2025 American Society of Hematology (ASH) Annual Meeting
MWN-AI** Summary
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) has announced that it will present Phase 2 data on its investigational drug SLS009 at the upcoming 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, from December 6-9, 2025. This Phase 2 trial is particularly relevant for patients suffering from relapsed or refractory acute myeloid leukemia (r/r AML) with myelodysplastic syndrome-related changes (AML-MR) after prior treatment with venetoclax. SLS009 is a selective CDK9 inhibitor being studied in combination with azacitidine (AZA) and venetoclax (VEN).
Angelos Stergiou, CEO of SELLAS, emphasized the importance of this presentation, stating that it reflects a growing body of evidence supporting SLS009's potential benefits in treating complicated hematologic malignancies. Alongside the presentation, an abstract discussing SLS009's mechanism of action has been published and indicates promising cytotoxic effects in AML cell lines with mutations associated with leukemia. These findings bolster hopes that SLS009 can effectively tackle resistance encountered with BCL-2 inhibitors.
The ASH presentation, titled "Phase 2 Study of SLS009 in Combination with Azacitidine and Venetoclax for Relapsed/Refractory AML with MDS-Related Changes (AML-MR)", is scheduled for December 7, 2025. The lead author is Dr. Joshua F. Zeidner from the University of North Carolina.
Additionally, SELLAS is focused on developing novel therapeutic solutions across various cancer types, including its lead candidate GPS, which targets the WT1 protein present in multiple tumors. As the company advances its clinical programs, it highlights the potential of SLS009 as a first-in-class, lower-toxicity CDK9 inhibitor capable of addressing significant unmet medical needs in oncology.
MWN-AI** Analysis
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is on the cusp of presenting pivotal Phase 2 data for its investigational drug SLS009 at the 2025 ASH Annual Meeting. This combination therapy with azacitidine and venetoclax targets relapsed or refractory acute myeloid leukemia (r/r AML) with myelodysplastic syndrome-related changes (AML-MR), a patient group that has shown limited treatment options. The findings could significantly impact SELLAS’s market position and stock performance.
Investors should closely monitor the upcoming presentation, scheduled for December 7, 2025. If the data suggests a favorable safety profile and robust efficacy, it could catalyze a positive market reaction, potentially driving the stock price upward as analysts revise price targets and ratings. Given the dire prognosis for patients with r/r AML and the high unmet medical need, successful outcomes from this study could position SLS009 as a groundbreaking therapy in a heavily scrutinized cancer segment.
Moreover, the preclinical data published in the ASH abstract supporting SLS009's mechanism of action against resistant AML cell lines further enhances investor sentiment around the drug's potential. The emphasis on SLS009's differentiation as a highly selective CDK9 inhibitor adds to its attractiveness, particularly given the current therapeutic landscape dominated by traditional chemotherapies and broader immunotherapies.
Despite this potential, investors should remain aware of the inherent risks associated with clinical trials, including regulatory hurdles and the necessity for subsequent trials. Understanding the risk-reward profile of SLS, particularly leading up to and following the ASH presentation, is crucial. Utilizing a cautious approach may be wise until more definitive data is disclosed. Overall, SELLAS could represent an interesting opportunity, provided investors stay informed about the outcomes of the forthcoming trial data.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
NEW YORK, Nov. 03, 2025 (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 data from its ongoing Phase 2 study of SLS009 for the treatment of relapsed or refractory acute myeloid leukemia (r/r AML) will be presented at the 67 th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 6 – 9, 2025, in Orlando, Florida. The Phase 2 trial is evaluating SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment.
“Our participation at this year’s ASH Annual Meeting underscores the growing body of evidence supporting SLS009 and its potential across hematologic malignancies,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS Life Sciences. “We look forward to sharing additional data from our clinical program and continuing to advance novel therapies that may improve outcomes for patients with difficult-to-treat cancers.”
In addition, an abstract highlighting the proposed mechanism of action of SLS009 has been published on the ASH Annual Meeting website and will also be available in Blood . The published preclinical abstract describes studies demonstrating the cytotoxic effects of SLS009 in AML cell lines with leukemia-driving mutations. The findings provide additional mechanistic support for SLS009 and reinforce its potential to address resistance to BCL-2 inhibition in AML.
ASH Presentation Details:
Title: Phase 2 Study of SLS009 in Combination with Azacitidine and Venetoclax for Relapsed/Refractory AML with MDS-Related Changes (AML-MR) After Prior Venetoclax Treatment
Session Date and Presentation Time : Sunday, December 7, 2025, 6:00 – 8:00 PM EST
Session Title: 616. Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster II
Location : Orange County Convention Center (OCCC) – West Halls B3-B4
Lead Author: Joshua F. Zeidner, MD, University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC
Publication Number : 3423
Blood Abstract Publication Details:
Title: Tambiciclib (SLS009), a Novel, Potent CDK9 Inhibitor is Effective in Killing ASXL1-Mutated and TP53 Knockout Acute Myeloid Leukemia Cell Lines
Authors : Elizabeth Trull 1 , Philip Amrein 1
1 Massachusetts General Hospital, Cancer Center, Boston, MA, United States
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 the 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 SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. 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, including the REGAL study and the timing of future milestones related thereto. 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 20, 2025 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
John Fraunces
Managing Director
LifeSci Advisors, LLC
jfraunces@lifesciadvisors.com
FAQ**
What are the expected outcomes from the Phase 2 study of SELLAS Life Sciences Group Inc. SLS009 in combination with azacitidine and venetoclax for r/r AML, and how might these results impact the company's future valuation?
How does the mechanism of action of SELLAS Life Sciences Group Inc. SLS009 differentiate it from other CDK9 inhibitors currently in development or on the market?
What key milestones should investors track regarding SELLAS Life Sciences Group Inc. SLS009, and how may upcoming presentations at the ASH Annual Meeting influence investor sentiment?
Considering the potential of SELLAS Life Sciences Group Inc. SLS009 to address resistance in AML, what do analysts project as the market demand for this therapy if clinical trials demonstrate positive outcomes?
**MWN-AI FAQ is based on asking OpenAI questions about SELLAS Life Sciences Group Inc. (NASDAQ: SLS).
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