SAR443579 — Investigational Agent
NK-Cell Engager · Phase 1/2 · Sanofi (Innate Pharma technology)
Mechanism of Action
Trifunctional natural killer (NK) cell engager (NKCE) that bridges CD123 on leukemic cells to two activating receptors on NK cells — NKp46 and CD16 (FcγRIIIa). CD123 (the IL-3 receptor alpha chain) is highly expressed on AML blasts and leukemic stem cells with limited normal-tissue expression. By co-engaging NKp46 and CD16, the molecule triggers potent, dual-signal NK-cell activation and antibody-dependent cellular cytotoxicity against CD123-positive cells while aiming to avoid the cytokine release syndrome severity typical of CD3 T-cell engagers.
Investigational Indications
- Relapsed/refractory acute myeloid leukemia (AML)
- B-cell acute lymphoblastic leukemia (B-ALL)
- High-risk myelodysplastic syndromes (MDS)
- Newly diagnosed AML in combination with azacitidine and venetoclax (exploratory)