Drug intelligence / Profile preview

TOL101

Development stage
Phase 2
Lead developer
Tolera Therapeutics
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

TOL101 is a murine IgM monoclonal antibody that specifically targets the human αβ T cell receptor (TCR) on T cells. It acts by binding reversibly to the αβ-TCR, resulting in rapid downmodulation of the CD3 receptor complex on αβ-TCR+ T cells without causing their depletion or inducing significant cytokine release. This non-depletional modulation leads to inactivation of targeted T cells and may induce operational tolerance. The drug has been investigated primarily as an induction therapy to prevent acute rejection in solid organ transplantation, particularly kidney transplants. Clinical studies have shown that it is well-tolerated and effective at modulating CD3+ cells at appropriate dosing levels[1][5][6][8]. The developer is Tolera Therapeutics[7].

Other names
murine IgM monoclonal antibody specific for the human alpha, beta T cell receptor
02

Targets

γδ TCR (T-cell receptor)

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