The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to AK117 (ligufalimab) for the treatment of acute myeloid leukemia (AML).
Ligufalimab is a humanized IgG4 monoclonal antibody developed by biopharmaceutical company Akeso. The therapy binds to CD47 on tumor cells, blocking its interaction with the SIRPα receptor, according to a press release from Akeso.
Clinical trials show a complete remission rate of 50% and composite complete remission rate of 55% at the target dose, with ligufalimab well tolerated up to 45 mg/kg and no significant safety differences, according to the press release from the company.
A phase 2 study is underway evaluating the safety and efficacy of ligufalimab in combination with venetoclax and azacitidine for first-line AML patients ineligible for intensive chemotherapy, the company reported.
