Ublituximab is a novel 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 (SubQ) 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.
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. In contrast to autologous CAR T cell therapies which are made
individually from a patient’s own cells, azer-cel is an allogeneic or “off-the-shelf” therapy made from
donor-derived T cells, modified using a proprietary gene editing technology. Azer-cel recognizes
the well characterized B cell surface protein CD19 and is designed to avoid graft-versus-host disease, a
significant complication associated with other donor-derived, cell-based therapies.
Ublituximab is a novel, glycoengineered monoclonal antibody designed to selectively target a unique epitope on CD20-expressing B cells. CD20 is a well-validated therapeutic target found on the surface of pre-B and mature B lymphocytes, which play a central role in the pathogenesis of multiple autoimmune diseases and B-cell malignancies.
Ublituximab is currently approved as an intravenous (IV) infusion for adults with relapsing forms of multiple sclerosis (RMS) (Click here for more information).
A subcutaneous (SUB-Q) formulation of ublituximab is currently being evaluated in a Phase 3 clinical trial for adults with RMS. The Phase 3 clinical trial is assessing a once-every-other month and once-per quarter SUB-Q injection. The target product profile is a self-administered SUB-Q auto-injector which can be self-administered at home. If successful, subcutaneous self-administration may offer greater flexibility for patients and healthcare providers, potentially reducing treatment burden and infusion-related resource utilization.
Click here to learn more about the Phase 3 trial evaluating subcutaneous ublituximab.
CD20 IV
CD20 SUB-Q
