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Mipletamig is a recombinant, bispecific T-cell engaging antibody developed by Aptevo Therapeutics. It targets both CD123 and CD3, redirecting the patient’s immune system to destroy leukemia cells expressing the surface antigen CD123. The drug is designed using Aptevo's ADAPTIR platform and features a unique CRIS-7 derived CD3 binding domain intended to reduce the likelihood and severity of cytokine release syndrome (CRS), a common complication with other bispecific antibodies. Mipletamig is administered intravenously and has received orphan drug designation for acute myeloid leukemia (AML). It is being investigated primarily as frontline therapy in combination with venetoclax and azacitidine for AML, but also in myelodysplastic syndromes (MDS) and other leukemias. Clinical trials have shown high remission rates with an improved safety profile compared to standard therapies[1][2][5][7][8].
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