elraglusib oral tablet / Actuate Therap - LARVOL DELTA

Actuate Therapeutics Announces FDA Clearance of IND for Oral Elraglusib and Strategic Initiatives to Advance the Elraglusib Development Program (GlobeNewswire) - "FDA cleared IND for Phase 1/2 study of oral elraglusib in advanced cancer patients, with focus on metastatic melanoma, NSCLC, colorectal, and pancreatic cancers with initiation planned for 2H 2026; Elraglusib plus RAS inhibitor preclinical results expected in mid-2026."

IND • New P1/2 trial • Preclinical • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer • Pancreatic Cancer

Actuate Therapeutics Announces Plans to Expand Clinical Pipeline, Advancing Elraglusib Tablet into a Phase 1/2 Clinical Program in Refractory Cancers (GlobeNewswire) - "Initiation of phase 1 portion of the trial planned in 2H 2026; Phase 2 portion of the trial will initiate development of the elraglusib tablet in specific indications, including refractory melanoma and additional target solid tumor and hematologic cancers...To support the broader development of the oral tablet formulation of elraglusib, Actuate also anticipates including additional targeted histologies in the final design of the Phase 1/2 study, including select hematologic malignancies where GSK3β inhibition has demonstrated activity and the potential for clinical benefit."

Clinical protocol • New P1/2 trial • Hematological Malignancies • Melanoma • Solid Tumor