Actuate Therapeutics Announces Publication Of New Data In Clinical Cancer Research From A Phase II Study; Reports Phase II Results Of Elraglusib With Platinum Chemotherapy Shows Median Survival Of 18.6 Months In Refractory Salivary Gland Cancer

Promising data show a median overall survival of 18.6 months, with 40% of patients alive at 2 years.

Results suggest that nuclear GSK-3β expression may help identify patients

most likely to respond to treatment of a historically difficult-to-treat refractory disease

CHICAGO and FORT WORTH, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ:ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the publication of new data in Clinical Cancer Research from a Phase II study (NCT05010629) evaluating elraglusib in combination with carboplatin or cisplatin (with or without sequential pembrolizumab priming) in patients with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma and other subtypes. The peer-reviewed paper (PMID: 41065505), entitled "Elraglusib, a Glycogen Synthase Kinase 3β Inhibitor, plus Chemotherapy with or without Immunotherapy in Patients with Recurrent, Metastatic Salivary Gland Carcinoma," is available here.

Despite decades of research, there are no approved systemic cytotoxic or targeted therapies available for the treatment of recurrent and metastatic salivary gland cancer. While some treatments have shown modest activity in certain molecular subgroups, such as HER2 (Human Epidermal Growth Factor Receptor 2)-overexpressing, androgen receptor-overexpressing, or NTRK (Neurotrophic Tyrosine Receptor Kinase)-fused tumors, most patients lack actionable therapeutic targets. Exploring new treatment options and novel therapeutic combinations represents a significant priority in salivary gland cancer.   This study represents one of the first clinical trials in advanced salivary gland cancer to explore sequential therapy and systemic treatments with varied therapeutic mechanisms in which single-agent approaches have so often yielded limited antitumor activity.

Elraglusib (9-ING-41) is a small-molecule inhibitor of GSK-3β with immune-modifying properties that disrupts multiple cellular signaling pathways, inhibits tumor growth, and increases sensitivity to chemotherapy. This phase II clinical trial evaluated elraglusib combined with platinum chemotherapy in patients with advanced, metastatic salivary gland cancer, including both adenoid cystic carcinoma (ACC) and non-ACC subtypes, with one cohort receiving sequential immune checkpoint inhibitor priming. A key finding in this study was that nuclear GSK-3β (glycogen synthase kinase 3β) expression was significantly higher in responders than non-responders (50% vs. 2%). Across the 32-patient study population, median progression-free survival was 6.4 months, with 27% of patients progression-free at 1 year. Additionally, median overall survival reached 18.6 months for the entire cohort and 27.8 months among non-ACC patients, with 40% of all patients alive at 2 years.