Drug intelligence / Profile preview

FDC101

Development stage
Phase 2
Lead developer
MediGene
Modality
Dendritic Cell Vaccines → Immune Effector Cells → Other Cell Types → Cell Therapies
Administration
Intradermal
01

Overview

FDC101 is an investigational **dendritic cell vaccine** composed of autologous dendritic cells loaded with the tumor-associated antigens WT1 (Wilms tumor 1) and PRAME (Preferentially Expressed Antigen in Melanoma). It is developed for **acute myeloid leukemia (AML)** and administered to stimulate the patient’s immune response against residual leukemia cells, aiming to improve overall survival, progression-free survival, and control of minimal residual disease in AML patients following standard therapy[1]. The vaccine is administered as a maintenance or consolidation immunotherapy over a 2-year period in a clinical trial setting.

Other names
WT1 and PRAME RNA-loaded dendritic cell vaccineWT-1 and PRAME RNA-loaded dendritic cell vaccineWT 1 and PRAME RNA-loaded dendritic cell vaccine
02

Targets

PRAME (Preferentially expressed antigen in melanoma)γδ TCR (T-cell receptor)WT1 (Wilms tumor protein)

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