ALX Oncology Holdings Inc. announced the presentation of clinical data from the Phase 1a dose escalation part of the ASPEN-05 trial evaluating evorpacept in combination with azacitidine and venetoclax for the treatment of patients with relapsed or refractory ("r/r") or newly diagnosed ("ND") acute myeloid leukemia ("AML"). The new results, shared in a poster at the 64(th) American Society of Hematology ("ASH") Annual Meeting [Abstract #4076], show that the combination of evorpacept with azacitidine and venetoclax is active and generally well tolerated. As of October 3, 2022, 14 patients with either r/r or ND AML have been treated with evorpacept in the Phase 1 dose escalation part of the study, administered at 20 mg/kg or 30 mg/kg once every 2 weeks ("Q2W") or 60 mg/kg once every 4 weeks ("Q4W") together with standard dosing of azacitidine and venetoclax.

Evoacepept in combination with azacitidine and venetoclax was generly well tolerated (N=14) with no maximumum tolerated dose identified and a maximum administered dose of 60 mg/kg Q4W. In 10 relapsed or refractory AML response-evaluable patients, including 8 that had progressed after prior venetoclax treatment, all experienced a reduction in bone marrow blasts, and 4 achieved a response. In 3 newly diagnosed AML response-evaluable patients, all 3 achieved a response, including 1 complete response ("CR"), 1 CR with incomplete hematologic recovery ("CRi"), and 1 morphologic leukemia free state ("MLFS").