Sellas Life Sciences completes Phase I trial dose escalation of GFH009

SELLAS Life Sciences announced completion of the safety evaluation stage of the highest dose cohort of patients with acute myeloid leukemia, AML, who relapsed after or were refractory to available antileukemic therapies in its Phase 1 dose escalation clinical trial of GFH009. No further dose escalations are planned in the AML group, while dose escalation continues in the lymphoma group with the addition of a 75 mg once-a-week dose cohort, which is planned to be the highest dose level for that group. The Company is finalizing the comprehensive data analysis to determine the recommended Phase 2 dose in AML, which will be announced following review by the U.S. Food and Drug Administration. SELLAS plans to commence a Phase 2a clinical trial during the second quarter of 2023 with GFH009 in combination with venetoclax and azacitidine in patients with AML who relapsed after or are refractory to treatment with venetoclax based therapies. The trial will be a single arm open label dose ranging study with one dose level at the RP2D and one dose below RP2D. Primary endpoints will be complete response composite rate and safety, and secondary endpoints will include duration of response, event free survival, overall survival and proportion of patients proceeding to transplant. Topline data from this study are expected in the fourth quarter of 2023.