Actuate Therapeutics provides update on clinical trial of elraglusib

Actuate Therapeutics provided an update on its Phase 1/2 trial of elraglusib in relapsed/refractory Ewing Sarcoma. The ongoing Phase 1/2 Trial is an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS and EWS-related pediatric small round cell sarcomas. To date, the study has enrolled 6 patients with relapsed/refractory EWS; one patient with a desmoplastic small round cell tumor, an ultra-rare, highly aggressive pediatric sarcoma; and one patient with a CIC rearrangement. All patients were treated with elraglusib in combination with cyclophosphamide/topotecan. Two patients with recurrent /refractory EWS are experiencing ongoing complete responses, two patients achieved stable disease, and two patients withdrew from the study before their tumor response could be assessed. The patient with Desmoplastic Small-Round-Cell Tumor achieved a partial response with a 52% reduction in tumor size but withdrew from the study and is now being followed for survival. The 1902 study remains open only to patients with recurrent EWS, who will be treated with the combination of elraglusib with cyclophosphamide/topotecan. The study will enroll up to 12 total EWS patients to provide additional rationale for moving the elraglusib/cyclophosphamide/topotecan combination into a phase 2 study in patients with recurrent EWS. Actuate plans to meet with the FDA to discuss the design of a phase 2 study and options for accelerating the development path for elraglusib to commercial registration for the treatment of EWS.