efgitasialase alfa

Efgitasialase alfa is a first-in-class engineered human sialidase fusion protein designed to enzymatically remove immunosuppressive sialoglycans from cell surfaces to enhance immune-mediated clearance of pathogenic cells in cancer and autoimmune disease. It consists of an engineered human sialidase (Neu2) fused to a human IgG1 Fc domain, enabling prolonged circulation and engagement with Fc receptor–mediated effector mechanisms such as antibody-dependent cellular phagocytosis and complement-dependent cytotoxicity.[3][7] By desialylating tumor cells and pathogenic immune subsets, efgitasialase alfa enhances T-cell activation and potentiates the activity of B-cell–targeting antibodies (e.g., anti-CD20 and anti-CD19), leading to improved depletion of CD27+ memory B cells and reduction of profibrotic M2-like macrophages that contribute to fibrosis and organ damage in chronic inflammatory and autoimmune settings.[2][3] The drug is being developed primarily by Palleon Pharmaceuticals, with Shanghai Henlius Biotech (HLX79) as a regional partner, and is in Phase 1/2 oncology trials (GLIMMER-01) in combination with anti–PD-1 therapy and Phase 2 trials in China in combination with rituximab biosimilar for glomerulonephritis, including lupus nephritis and idiopathic membranous glomerulonephritis.[1][3][6]

Other names

E-602E602E 602HLX79HLX-79HLX 79Bi-SialidaseSialidase Fc fusion protein