IGM Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared two Investigational New Drug (IND) applications for imvotamab, an IgM-based CD20 X CD3 bispecific antibody T cell engager, enabling the initiation of Phase 1b studies in both severe systemic lupus
erythematosus (SLE) and severe rheumatoid arthritis (RA). The Company plans to begin patient enrollment in both multicenter clinical studies in the third quarter of 2023. The data from non-Hodgkin's lymphoma clinical studies indicate that imvotamab can deplete CD20 expressing B cells, even rapidly growing lymphoma
cells, with a favorable safety profile as compared with other T cell engaging CD20 x CD3 antibodies. Emerging data with cell-based therapies suggest that deep B cell depletion may have the potential to reset the immune system in patients with certain autoimmune diseases. Imvotamab has also demonstrated in preclinical in vitro studies that it can be more effective in depleting B cells with low levels of CD20 expression as compared to rituximab.