Ublituximab

CD20, an antigen expressed by various B and T cells, is an attractive therapeutic target in various cancers and autoimmune conditions. Monoclonal antibodies for B cell depletion rely on their binding affinity and ability to clear bound cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), mediated by interactions between an antibody and Fcγ receptors on natural killer cells or macrophages. Ublituximab is a chimeric anti-CD20 IgG1κ antibody produced in the rat YB2/0 cell line to target a unique epitope and enhance ADCC compared to other approved anti-CD20 antibodies such as rituximab, ofatumumab, obinutuzumab, and ocrelizumab.

Ublituximab was initially developed by LFB Group but was licensed to TG Therapeutics in 2012. It has been investigated for use in numerous B cell-dependent conditions, including chronic lymphocytic leukemia, non-Hodgkin's lymphoma, and relapsing multiple sclerosis. In December 2022, ublituximab was approved by the US FDA for the treatment of relapsing forms of multiple sclerosis, becoming the first and only anti-CD20 monoclonal antibody for multiple sclerosis allowing for administration in a one-hour infusion twice-a-year following the starting dose. The next year, June 2023, ublituximab was also approved by the EMA for the treatment of relapsing forms of multiple sclerosis in adult patients.

Ublituximab is indicated in adult patients for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease by the FDA. It is also indicated by the EMA to treat relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.