June 20, 2025, Chicago, Texas and Fort Worth (Globe Newswire) – Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or “Company”), clinical stage biopharmaceutical companies, and clinical stage biopharmaceutical companies focused on developing treatments for the treatment of highly impactful, challenging integrated enzymes of integrated Zyase dermatosis. (GSK-3β) today presents biomarker data from a recent poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. This study demonstrated the use of machine learning and statistical models to predict overall survival (OS) based on pre-dose plasma biomarkers.
The poster described the analysis of 40 cytokines, chemokines, soluble cell receptors, and growth factors (CCSGs) from plasma samples obtained before treatment from all patients enrolled in ACTUATE-1801 Part 3B. In the analysis, seven biomarkers were identified as uniquely significant predictors of favorable survival in an Eluluglusive-treated cohort containing one CXCL2 with an inverse survival tendency compared to the GNP control arm. This indicates that high CXCL2 is unfavourable in patients not treated with el-raglusiv, but this trend is reversed with el-raglusiv treatment, highlighting the possibility that el-raglusiv may have a positive effect on the immune microenvironment.
Univariate analysis revealed strong predictive performance that has emerged as a consistent and reliable biomarker for survival across multiple cross-validation analyses. Increased levels of CXCL2 and TRAIL were associated with improved OS, whereas lower levels of CCL3, IL-1α, IL-18, TGF-β, and TRAIL R3 were similarly associated with improved survival. These signatures were combined into a multivariate machine learning model that accurately predicts patients who will survive for more than one year when treated with Eruluglusib and GNP.
“These results represent important advancements in biomarker strategies,” said Daniel Schmitt, president and CEO of Actuate. “They support the ability to potentially identify patients who are likely to benefit from Elulusive using simple, non-invasive blood-based markers. The pre-dose biomarker signatures identified in the 1801 Part 3B study, particularly high TGF-β, CCL3, and IL-18, suggest that everything is present. The effects of regulating cytotoxic T cells, NK cells, and myeloid lineages, including crosstalk between macrophages and neutrophils.
“The application of impartial mathematics and machine learning models allowed us to freely identify the strongest biomarker signals from pre-recognized concepts of Elraglusib's mechanisms. What's very exciting about this project is that it is consistent with previous mechanism research: identifying the right patients at the right time,” said Dr. Taylor Weistittel, the lead author of the study. “We look forward to applying this approach to guiding the development of Elluglusib in MPDAC and other advanced cancer indications in the future.”
The company plans to prospectively test biomarkers identified in future trials. Additional efforts will focus on optimizing continuous univariate combinations for patient stratification, refinement of multivariate machine learning models for predictive accuracy, and comparing these approaches head-on.
Actuate Therapeutics, Inc. About
Actuate is a clinical stage biopharmaceutical company focusing on developing treatments for the treatment of shocking and difficult-to-treat cancers. Elraglusib, Actuate's lead treatment (a novel GSK-3β inhibitor), targets the molecular pathways of cancer that are involved in promoting tumor growth and promoting resistance to chemotherapy through inhibition of nuclear factor Kappa-light-chain-Enhancer's activated B cells (NF-KB) and DNA damage response (DDR) (DDR). Elraglusib may also mediate antitumor immunity through multiple immune checkpoints and regulation of immune cell function. For more information, please visit the company's website: http://www.actuatetherapeutics.com.
Forward-looking statements
This press release contains forward-looking statements about us, including our and other parties' clinical trials and development plans, as well as the industry. Includes negatives that include “prediction”, “believe”, “continue”, “prospect”, “intention”, “will”, “will”, or “will”, or negativity that includes negatives of these conditions. words. All statements contained in this press release other than statements regarding current facts or current terms or historical facts are forward-looking statements. Therefore, these statements include estimates, assumptions, substantial risks, and uncertainties that may differ materially from the results expressed in them. This includes preliminary and unpublished data, including biomarker studies, following more comprehensive reviews, following more data availability and more comprehensive reviews, depending on the final analysis. Clinical and preclinical drug development involves long-term and expensive processes with uncertain timelines and outcomes, results from previous preclinical research, early clinical trials, machine learning, and predictive modeling results, and does not necessarily predict future outcomes, and Erraglusiv may not be able to obtain positive or favorable preclinical results. It is not possible to enroll additional patients or establish or advance plans for further development, including conversations with the FDA or EMA or criteria that such organizations may impose for such development. Elraglusib may be associated with side effects, adverse events, or other characteristics or safety risks that may delay or eliminate regulatory approval, which may suspend or suspend clinical trials or result in other negative outcomes. Reliance on third parties to conduct non-clinical research and clinical trials. Reliance on third-party licensors and the ability to maintain and protect intellectual property rights. Faced with important competition with other biotechnology and pharmaceutical companies. We may raise great doubt about our ability to continue as a continuing concern and require additional capital to fund our operations beyond the second quarter of 2025, so if we fail to acquire this necessary capital on our ability to fund development activities and terms of acceptability, or delay, limit, reduce or terminate our development program, commercialization efforts at all. Additionally, forward-looking statements are provided in the quarterly report for Form 10-K, which ended March 31, 2024, in the quarterly report for Form 10-Q, which was filed with the SEC on March 13, 2025 and included in the quarterly report for Form 10-Q, which ended March 31, 2025. The risk factors mentioned above should not undue rely on forward-looking statements as actual results and results may differ materially from those expressed in forward-looking statements made on our behalf or on our behalf. Additionally, forward-looking statements will only be spoken as of the date on which they are made. New factors appear occasionally, and it is not possible to predict which factors will occur. Furthermore, we cannot evaluate that the impact of each factor on our business, or combination of factors, will significantly differ from the results contained in forward-looking statements. Except as required by law, we have no obligation to publish revisions to such forward-looking statements to reflect events or circumstances beyond the date of this press release or to reflect the occurrence of unexpected events.
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President
Lifesci Advisors, LLC
mmoyer@lifesciadvisors.com
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