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FDA Grants Approval to IGM Biosciences for Clinical Studies of Imvotamab in Lupus and Rheumatoid Arthritis

Thursday, June 01, 2023

IGM Biosciences, a clinical-stage biotechnology company focused on IgM antibodies, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for two Investigational New Drug (IND) applications for imvotamab. Imvotamab is an IgM-based CD20 X CD3 bispecific antibody T cell engager. This clearance allows IGM Biosciences to initiate Phase 1b studies in 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.

According to Dr. Mary Beth Harler, President of IGM Autoimmunity and Inflammation, treating autoimmune diseases with T cell engagers is an exciting area of therapeutic research. Imvotamab has the potential to lead and transform treatment in this field. Previous clinical studies of imvotamab in non-Hodgkin's lymphoma have shown its ability to deplete CD20 expressing B cells, including rapidly growing lymphoma cells, with a favorable safety profile compared to other CD20 x CD3 antibodies. There is growing evidence that deep B cell depletion may reset the immune system in certain autoimmune diseases. IGM Biosciences looks forward to initiating Phase 1b clinical trials for SLE and RA patients and fully exploring the potential of imvotamab and other IgM-based T cell engagers in autoimmune diseases.

The primary objectives of the Phase 1b clinical trials for SLE and RA will include evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of imvotamab in patients with severe forms of these diseases who have not responded to multiple prior therapies. Preclinical studies have demonstrated that imvotamab can achieve deep B cell depletion within tissues, which may be critical for long-term clinical benefits in autoimmune diseases. In vitro studies have also indicated that imvotamab is more effective in depleting B cells with low levels of CD20 expression compared to rituximab. Moreover, recent results from Phase 1 and Phase 2 studies in non-Hodgkin's lymphoma have shown a lower incidence of cytokine release syndrome (CRS) compared to other CD20 x CD3 bispecific antibodies used in similar clinical studies.

Imvotamab (IGM-2323) is a novel IgM-based CD20 x CD3 bispecific antibody T cell engager (TCE). It is believed to offer advantages over IgG bispecific antibodies, particularly in terms of its binding power to CD20 expressing cells, even when CD20 expression levels are low.

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