SELLAS Life Sciences to Present In Vivo Preclinical Data Demonstrating Statistically Significant Survival Benefit of SLS009 in T-Cell Prolymphocytic Leukemia at the European Society for Medical Oncology (ESMO) Congress 2025
MWN-AI** Summary
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) recently announced its intention to present impactful preclinical data at the upcoming European Society for Medical Oncology (ESMO) Congress 2025, taking place in Berlin from October 17 – 21, 2025. The data showcases the efficacy of SLS009, a highly selective CDK9 inhibitor, in treating T-cell prolymphocytic leukemia (T-PLL), an aggressive form of leukemia with limited treatment options.
The findings will be highlighted using an in vivo patient-derived xenograft (PDX) model that accurately reflects key human clinical and pathological characteristics of T-PLL. In this study, SLS009 demonstrated significant monotherapy activity, and was even more effective when combined with venetoclax, a BCL2 inhibitor. The results indicated that patients receiving SLS009 alone experienced an average overall survival of 7.4 weeks, while those on the combination therapy saw survival extend to 7.9 weeks. Both treatments significantly outperformed venetoclax alone, which had an average survival of 4.4 weeks, with differences deemed statistically significant (p<0.05).
Dr. Dragan Cicic from SELLAS expressed optimism about these results, highlighting the potential of SLS009 to enhance treatment protocols for T-PLL and broaden therapeutic applicability across various hematological malignancies. Furthermore, Dr. Francisco Vega from MD Anderson Cancer Center emphasized the robustness of the PDX model, which facilitates swift and meaningful clinical translation for promising therapies like SLS009.
In conclusion, the preclinical results for SLS009 represent a significant advancement in the fight against T-PLL, and the upcoming ESMO Congress presentation is anticipated to generate considerable interest within the oncology community.
MWN-AI** Analysis
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is poised to capture investor interest with the upcoming presentation of preclinical data demonstrating statistically significant survival benefits of its CDK9 inhibitor, SLS009 (tambiciclib), in T-Cell Prolymphocytic Leukemia (T-PLL) at the European Society for Medical Oncology (ESMO) Congress 2025. The results from the patient-derived xenograft (PDX) model reveal that SLS009, both as a monotherapy and in combination with venetoclax, extended patient survival significantly more than venetoclax alone.
These results are crucial, especially considering the limited treatment options for T-PLL, which is known for its aggressive nature. The compelling data suggests not only the efficacy of SLS009 but also positions it as a potential game-changer in the management of this rare leukemia. The combination regimen was shown to be well-tolerated, an essential factor in securing broader acceptance in clinical settings.
Investors should monitor SELLAS closely in light of these developments. Positive outcomes from the ESMO presentation may lead to increased interest from institutional investors and analysts focusing on novel oncology treatments. Moreover, successful translation of these preclinical findings into clinical settings could catalyze discussions regarding strategic partnerships to expedite SLS009’s development.
While the potential upside is significant, investors should remain wary of the inherent risks associated with oncology drug development, including regulatory hurdles and market competition. Given the volatility typically associated with biopharmaceutical stocks, current shareholders might consider leveraging the momentum post-presentation for strategic buy or sell decisions.
In conclusion, SELLAS Life Sciences is at a pivotal moment with SLS009, and its market performance will likely reflect the excitement surrounding its ESMO congress presentation. Investors should keep an eye on upcoming catalysts for informed investment decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
NEW YORK, Oct. 13, 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 preclinical efficacy of its highly selective CDK9 inhibitor, SLS009 (tambiciclib), as a monotherapy and in combination with venetoclax in T-cell prolymphocytic leukemia (T-PLL), will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17 – 21, 2025, in Berlin, Germany.
The results highlight an in vivo patient-derived xenograft (PDX) model of relapsed/refractory T-PLL that reproduced key human clinicopathological features of the disease. In this model, SLS009 demonstrated meaningful single-agent activity as well as in combination with the BCL2 inhibitor venetoclax. Both SLS009 monotherapy and the combination prolonged overall survival (7.4 weeks and 7.9 weeks, respectively) compared to venetoclax alone (4.4 weeks), a difference that was statistically significant (p<0.05), and SLS009 achieved better control of circulating T-PLL cells in the peripheral blood relative to other treatments. The combination regimen was also well tolerated in the study.
“These results are highly encouraging and provide important preclinical evidence that selective CDK9 inhibition with SLS009 may play a critical role in the treatment of T-PLL, an aggressive leukemia with very limited treatment options,” said Dr. Dragan Cicic, Senior Vice President, Chief Development Officer at SELLAS. “Notably, SLS009 alone and in combination with venetoclax prolonged survival more effectively than venetoclax monotherapy, while demonstrating favorable tolerability. This reinforces the potential of SLS009 to improve outcomes in T-PLL and broadens its therapeutic relevance across additional hematologic malignancies that require novel treatment approaches.”
“The T-PLL patient-derived xenograft model we developed is highly robust and closely mirrors the behavior and progression of the disease in humans,” said Dr. Francisco Vega, Professor and Head of the Lymphoma Section in the Department of Hematopathology at the University of Texas MD Anderson Cancer Center (MDACC) and lead author of the study. “This breakthrough allows for more rapid and meaningful translation into the clinic, greatly accelerating drug development by enabling us to evaluate novel therapies with strong clinical potential, such as SLS009, without waiting years for early clinical trial results.”
Poster Presentation Details:
Title: CDK9 Inhibition Enhances Venetoclax Activity and Prolongs Survival in a T-PLL Patient-Derived Xenograft Model
Session Date and Time : Saturday, October 18, 2025, 12:00 PM – 12:45 PM CEST; poster on display from 9:00 AM – 5:00 PM CEST
Session Title: Haematological Malignancies
Location : Poster Area Hall 25
Lead Author: Francisco Vega, MD, PhD, Hematopathology Department, University of Texas MD Anderson Cancer Center, Houston, TX
Abstract # : FPN: 1284P
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
FAQ**
What are the anticipated key outcomes from the presentation on the efficacy of SLS009 at the ESMO Congress 2025, and how might this impact SELLAS Life Sciences Group Inc. SLS's stock performance?
Given the promising results for SLS009 in treating T-PLL, what potential market opportunities do you foresee for SELLAS Life Sciences Group Inc. SLS in the oncology sector?
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**MWN-AI FAQ is based on asking OpenAI questions about SELLAS Life Sciences Group Inc. (NASDAQ: SLS).
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