Ublituximab is a novel glycoengineered monoclonal antibody that targets a unique epitope on
CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological
reactions (including antibody-dependent cellular cytotoxicity [ADCC] and complement dependent
cytotoxicity [CDC]), leading to destruction of the cell. Additionally, ublituximab is uniquely designed
to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a
process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the
ADCC activity.
Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the
management of B-cell malignancies and autoimmune disorders, both diseases driven by the abnormal growth
or function of B-cells.
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Azercabtagene zapreleucel (“azer-cel”) is an investigational, anti-CD19 allogeneic chimeric antigen receptor (CAR) T-cell therapy being developed for the treatment of B-cell mediated autoimmune conditions. Azer-cel targets CD19, a well-characterized surface antigen broadly expressed across B-cell lineages, making it an established and clinically validated target for autoimmune disorders characterized by dysregulated B-cell activity.
Unlike autologous CAR T-cell therapies, which are individually manufactured from each patient’s own T cells, azer-cel is an allogeneic, or “off-the-shelf,” therapy derived from healthy donor T cells. These donor cells are modified using proprietary gene-editing technology to express a CD19-directed CAR while minimizing the risk of graft-versus-host disease (GvHD).
The allogeneic approach is designed to enable rapid availability, consistent product quality, and scalable manufacturing, addressing key limitations of autologous CAR T-cell therapies. Azer-cel is currently in a Phase 1 clinical trial designed to establish the safety, tolerability, and preliminary clinical activity in patients with multiple sclerosis and other select immune mediated neurologic conditions.
Ublituximab is a novel glycoengineered monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. When ublituximab binds to the B-cell it triggers a series of immunological reactions (including antibody-dependent cellular cytotoxicity [ADCC] and complement dependent cytotoxicity [CDC]), leading to destruction of the cell. Additionally, ublituximab is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, has been shown to enhance the potency of ublituximab, especially the ADCC activity.
A subcutaneous (SUB-Q) formulation of ublituximab is currently being studied in a phase 3 clinical trial for adults with relapsing forms of multiple sclerosis (RMS).
Click here to learn more about the Phase 2 trial evaluating subcutaneous ublituximab.
CD20 IV
CD19 CAR-T
