China-based IASO Bio has announced that the US Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) filing for its pipeline candidate, IASO-782. This injectable drug candidate will be assessed in US clinical trials for the treatment of various autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).
IASO-782: A Fully Human Monoclonal Antibody Targeting CD19
IASO-782 is a fully human monoclonal antibody that targets human CD19, with Fc mutations designed to enhance Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) function while leaving other Fc functions, such as Antibody-Dependent Cellular Phagocytosis (ADCP), Complement-Dependent Cytotoxicity (CDC), and FcRn binding, unaffected. The B cell surface antigen CD19 is expressed throughout B cell development, from pre-B cells through plasmablasts and in some plasma cells.
Potential Impact on Autoimmune Diseases
Many autoimmune diseases, such as ITP and AIHA, are primarily mediated by auto-reactive antibodies produced by pathogenic B and plasma cells. IASO-782 can efficiently deplete CD19+ B cells, plasmablast cells, and some plasma cells in humans, thereby reducing or completely eliminating auto-reactive antibodies produced by these cells. This mechanism of action positions IASO-782 as a potential treatment for a range of autoimmune diseases associated with auto-reactive antibodies.-Fineline Info & Tech
