ublituximab   Click here for help

GtoPdb Ligand ID: 8920

Synonyms: Briumvi® | LFB-R603 | TG-1101 | TGTX-1101 | ublituximab-xiiy
Approved drug Immunopharmacology Ligand
ublituximab is an approved drug (FDA (2022), EMA (2023))
Compound class: Antibody
Comment: Ublituximab is a novel third-generation anti-CD20 monoclonal antibody, CD20 being the B lymphocyte cell surface glycoprotein encoded by the MS4A1 gene. This chimeric antibody has been glycoengineered (namely, having a low fucose content in its Fc region) to optimise FcγRIIIA (CD16a) binding, to enhance antibody-dependent cell-mediated cytotoxicity [1-2]. It is being investigated for its immunomodulatory potential.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.
Ublituximab shows similar specificity and a similar glycosylation pattern to the anti-CD20 mAb EMAB-6 [1].
No information available.
Summary of Clinical Use Click here for help
Ublituximab was advanced to clinical trials for B lymphoid malignancies. In 2009 the EMA granted orphan designation for ublituximab as a treatment for chronic lymphocytic leukaemia (CLL). A number of clinical trials in B cell malignancies were terminated, althoug te phase 1 study NCT04806035 appears to be active (Jan 2023). Ublituximab was repositioned as a treatment for multiple sclerosis (MS), with first approval being issued by the FDA in December 2022, for the treatment of relapsing forms of MS.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02656303 An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304 Phase 2 Interventional TG Therapeutics, Inc.
NCT03381170 An Extension of the TG1101-RMS201 Trial Phase 2 Interventional TG Therapeutics, Inc.
NCT04130997 An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis Phase 3 Interventional TG Therapeutics, Inc.
NCT04806035 Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia Phase 1 Interventional TG Therapeutics, Inc. In this study ublituximab is being combined with the anti-CD47/CD19 bispecific monoclonal TG-1801. TG-1801 targets CD47 selectively on CD19 +ve B cells, thus sparing red blood cells and platelets.