Drug intelligence / Profile preview

theralizumab

Development stage
Phase 2
Lead developer
TeGenero Immuno Therapeutics
Modality
Recombinant Proteins and Enzymes, IgG Antibodies → Naked Antibodies → Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Theralizumab is a humanized IgG4 monoclonal antibody that acts as a superagonist of the CD28 receptor on T cells. It was originally developed for the treatment of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus (SLE), as well as B-cell chronic lymphocytic leukemia and other cancers. Theralizumab directly stimulates T cells by binding to the CD28 co-receptor and can induce strong immunomodulatory effects. The drug became widely known after its first-in-human trial in 2006 resulted in severe cytokine release syndrome ("cytokine storm") and multiple organ failure in healthy volunteers. Development was initially halted but later resumed under the name TAB08 with lower dosing strategies aimed at selectively activating regulatory T cells (Tregs) to suppress inflammation without triggering dangerous systemic immune activation[1][2][3][5][10].

Other names
theralizumabTGN1412TGN-1412TGN 1412TAB08TAB-08TAB 08TABO8TABO-8TABO 8CD28-SuperMABCD-28-SuperMABCD 28-SuperMAB
02

Targets

CD28 (Cluster of Differentiation 28)

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