ACTU News & Events

Actuate Therapeutics announced plans to initiate a Phase 1/2 clinical program evaluating the oral tablet dosage form of elraglusib in patients with advanced cancer. The phase 1 portion of the planned Phase 1/2 program aims to determine the maximum tolerated dose or maximum administered dose and dose-limiting toxicities of elraglusib tablets administered once daily and will investigate the pharmacokinetics of elraglusib tablets as well as the preliminary anti-tumor activity of elraglusib when administered as tablets. The goal of the phase 1 portion of the program will be to establish the recommended dose of elraglusib tablets for expansion in subsequent development

Actuate Therapeutics announced that new additional and promising patient survival and biomarker data from treatment with elraglusib for metastatic pancreatic cancer were featured in oral and poster presentations at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium on January 9, 2026. The presentations highlighted new, expanded data from the company's Phase 2 clinical program evaluating elraglusib in combination with gemcitabine/nab-paclitaxel, a first-line chemotherapy regimen for metastatic pancreatic cancer, providing additional evidence that suggests that elraglusib combined with GnP is associated with improved survival when compared with GnP alone. The primary efficacy endpoints were met in this study: The median overall survival showed significant benefit in the elraglusib/GnP vs GnP alone arms; 12-month survival rate doubled to 44.4% vs 22.3%; 24-month survival rate increased fivefold to 12.9% in the elraglusib/GnP arm compared to 2.6% in the GnP arm, emphasizing the potential for long-term clinical benefit. The safety and tolerability profile of elraglusib was consistent with previously reported data at the 9.3 mg/kg dose, and no new safety signals were identified: Serious TEAE were similar between the elraglusib/GnP and the GnP alone arm, TEAE resulting in death were similar between treatment arms: elraglusib/GnP and GnP alone; Grade-3 or higher TEAE leading to stoppage of any study drug: elraglusib/GnP and GnP alone.

Actuate Therapeutics announced results from the phase 1 portion of its phase 1/2 clinical study evaluating elraglusib as a monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or with cyclophosphamide plus topotecan in pediatric patients with refractory malignancies. The Actuate-1902 trial was an open-label, multicenter phase 1/2 study evaluating the safety and efficacy of elraglusib in 40 pediatric patients ages 3 - 21 with relapsed/refractory cancers, including Ewing sarcoma, neuroblastoma, Central Nervous System tumors, non-EWS sarcomas, and other refractory pediatric malignancies. Summary: Two Complete Metabolic Responses observed in patients with relapsed/refractory metastatic Ewing sarcoma and one Complete Response observed in a patient with relapsed/refractory metastatic neuroblastoma; Clinical responses and disease control observed in 15 of 40 patients with difficult-to-treat refractory pediatric cancers, including 10 of 19 patients treated with elraglusib plus cyclophosphamide/topotecan; Data support advancing clinical development of elraglusib in Ewing sarcoma and potentially neuroblastoma in 2026; Company has been granted Rare Pediatric Designations from the FDA for both indications

Actuate Therapeutics announced the publication of new data in Clinical Cancer Research from a Phase II study evaluating elraglusib in combination with carboplatin or cisplatin in patients with advanced, metastatic salivary gland cancers, including adenoid cystic carcinoma and other subtypes. The peer-reviewed paper is entitled "Elraglusib, a Glycogen Synthase Kinase 3beta Inhibitor, plus Chemotherapy with or without Immunotherapy in Patients with Recurrent, Metastatic Salivary Gland Carcinoma,". Elraglusib is a small-molecule inhibitor of GSK-3beta 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 and non-ACC subtypes, with one cohort receiving sequential immune checkpoint inhibitor priming. A key finding in this study was that nuclear GSK-3beta expression was significantly higher in responders than non-responders. 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. Key Highlights and Readouts: Both adenoid cystic carcinoma and non-ACC patients were enrolled, with a total enrollment of 32 patients, in partnership with the Center for Head and Neck Oncology at Dana-Farber Cancer Institute in Boston, Massachusetts. Median OS was 18.6 months. At 1 year, 58% of patients were alive; at 2 years, 40% remained alive. Non-ACC patients had a median OS of 27.8 months. Median PFS was 6.4 months; 27% of patients remained progression-free at 1 year. Historical PFS for this population is estimated at 4-9 months for ACC and less than6 months for non-ACC. Three patients, all of whom were non-ACC and had PD-L1 scores less than1%, had Partial Responses, indicating responses occurred despite low tumor immunogenicity. The median duration of response was 6.9 months. Two of three responders had CDKN2A/B and MTAP co-deletion, a molecular profile that typically predicts poor response to chemotherapy and immunotherapy-suggesting elraglusib may provide added benefit in this subgroup. Median nuclear GSK-3beta expression was 50% in responders vs. 2% in non-responders. Patients with above-median nGSK-3beta expression had longer median PFS and numerically longer OS. The combination was well tolerated: no treatment-related deaths occurred, and only 6% were discontinued due to toxicity. The most common treatment-related adverse events were anemia, nausea, and neutropenia.