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M2T-CD33
- Development stage
- Preclinical
- Lead developer
- Leukogene Therapeutics
- Modality
- Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
01
Overview
M2T-CD33 (also known as LTI-214) is a myeloid-targeted immunotherapy being developed by Leukogene Therapeutics for the treatment of acute myeloid leukemia (AML). The drug is a recombinant fusion protein utilizing the proprietary M2T platform, which consists of the extracellular domain of CD33 conjugated to a modified superantigen (SMEZ-2 M1). It functions as an antigen-presenting cell (APC) engager by binding to MHC class II (MHCII) molecules and selectively targeting CD33-positive leukemic blasts and stem cells. This interaction stimulates a potent T and B cell-mediated immune response against the tumor cells. M2T-CD33 received FDA orphan drug designation in November 2025 and has demonstrated robust anti-leukemic activity in preclinical studies without evidence of cytokine release syndrome.
- Other names
- LTI-214LTI214LTI 214
02
Targets
MHC II (Major histocompatibility complex class II receptor)CD33 (Myeloid cell surface antigen CD33)
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