- Actuate Therapeutics (ACTU, Financial) reports positive Phase 1 trial results for Ewing Sarcoma.
- Complete responses achieved in 2 of 10 patients; partial response observed in DSRCT patient.
- Plans for a Phase 2 trial in 2026 contingent on funding.
Actuate Therapeutics (ACTU) has announced promising results from its Phase 1 trial of elraglusib, targeting pediatric patients with refractory malignancies, particularly Ewing Sarcoma (EWS). In this study, 2 out of 10 EWS patients achieved complete responses, while another 2 maintained stable disease. Furthermore, a patient with a desmoplastic small-round-cell tumor (DSRCT) exhibited a partial response.
The drug, elraglusib, acts on glycogen synthase kinase-3 beta (GSK-3?), demonstrating potential as a first-in-class therapy for EWS, an area with no existing approved targeted therapies. Actuate plans to progress to a Phase 2 trial involving children, adolescents, and adults with relapsed/refractory EWS, projected to begin in 2026, pending financial backing.
Currently, the treatment landscape for EWS is challenging, with patients having limited options beyond chemotherapy and typically facing low survival rates. Elraglusib's promising early results offer hope for improved outcomes in this difficult-to-treat cancer. Actuate's strategic plan includes collaborating with key stakeholders to ensure the forthcoming trial meets both patient needs and regulatory requirements.
