adargiminase

NEI-01 (adargiminase) is a novel arginine-depleting enzyme designed for cancer therapy. It incorporates an albumin-binding domain, allowing it to bind to human serum albumin and thereby extend its circulating half-life. NEI-01 targets tumors that are auxotrophic for arginine—specifically those with low or absent expression of argininosuccinate synthase 1 (ASS1), such as certain acute myeloid leukemias (AML) and solid tumors. By depleting extracellular arginine, NEI-01 induces cell-cycle arrest and apoptosis in ASS1-deficient cancer cells, demonstrating potent anticancer activity in preclinical models including xenografts of AML and pancreatic cancer[1][3][4]. Early-phase clinical trials are ongoing in patients with advanced solid tumors and relapsed/refractory AML[2].