Core Insights - Actuate Therapeutics has completed the Phase 1 study of elraglusib in pediatric patients, showing promising results in treating refractory Ewing Sarcoma (EWS) [1][2][3] - The company plans to advance to a Phase 2 trial for elraglusib in children, adolescents, and adults with relapsed/refractory EWS due to the observed complete responses [1][3] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers, specifically through the inhibition of glycogen synthase kinase-3 beta (GSK-3β) [1][6] - Elraglusib, the company's lead investigational drug, targets molecular pathways involved in tumor growth and resistance to conventional cancer treatments [6] Clinical Study Details - The Phase 1/2 trial (NCT 04239092), known as Actuate-1902, is an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS [2][3] - The study enrolled ten patients with relapsed/refractory EWS, with two patients achieving complete responses and two others showing stable disease [3] Future Plans - The company is planning to initiate a Phase 2 trial in 2026, subject to funding availability, and will engage with regulators to discuss the potential registration path for elraglusib [3][1] - Actuate is collaborating with key opinion leaders and consortiums to ensure the upcoming study design meets patient needs and regulatory expectations [3]
Actuate Therapeutics Advances Clinical Program in Ewing Sarcoma After Positive Phase 1 Trial Demonstrates Complete and Partial Responses in Difficult-to-Treat Pediatric Sarcomas