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Tebotelimab (previously known as MGD013) is an investigational, bispecific DART® molecule designed to independently or coordinately block PD-1 and LAG-3 checkpoint molecules to sustain or restore the function of exhausted T cells for the treatment of cancer. Monoclonal antibodies that target the immune checkpoints Lymphocyte-activation gene 3 (LAG-3) and PD-1 may have enhanced clinical activity when given in combination. Tebotelimab has been engineered to bind PD-1 and LAG-3 concomitantly or independently and disrupt these non-redundant inhibitory pathways to further restore exhausted T-cell function.
MacroGenics has also reported (ASCO 2020 Virtual Scientific Program) that LAG-3 expression on immune effector cells was shown to be enhanced by margetuximab, MacroGenics’ investigational Fc-engineered monoclonal antibody targeting HER2. Given the early signal of activity and acceptable safety profile observed in an initial, small expansion cohort of patients, the Company is evaluating the combination of tebotelimab and margetuximab in patients with HER2-positive tumors. The Company believes that combining Fc-engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments.
Tebotelimab is currently being evaluated in a Phase 1 study in which the dose and schedule have been established. Monotherapy dose expansion is ongoing in select tumor types with unresectable, locally advanced or metastatic solid tumors or hematologic malignancies. A separate cohort is also being conducted to evaluate the combination of tebotelimab and margetuximab in subgroups with HER2-postive cancers.
MacroGenics is collaborating on the development and commercialization of tebotelimab with Zai Lab in Greater China. MacroGenics retains full development and commercialization rights in all other territories.
Relevant Publications and Presentations can be found at https://www.macrogenics.com/publications/.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.