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RGI-2001
- Development stage
- Phase 2
- Lead developer
- REGiMMUNE
- Modality
- Small Molecules, Liposomes → Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Administration
- Intravenous
01
Overview
RGI-2001 is a liposomal formulation of an alpha-galactosylceramide (alpha-GalCer) analog, specifically a synthetic derivative related to KRN7000. It acts as a ligand for the CD1d receptor on antigen-presenting cells and invariant natural killer T (iNKT) cells. By binding to CD1d, RGI-2001 activates iNKT cells, which in turn promote the expansion of regulatory T cells (Tregs). This mechanism induces immune tolerance and is being developed primarily for the prophylaxis of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic cell transplantation. The drug is currently in Phase 3 planning after positive results from Phase 2b studies showing efficacy in reducing clinically significant aGVHD when added to standard-of-care immunosuppression regimens such as tacrolimus/methotrexate[1][2][3][6][8].
- Brand names
- ToleroVax
- Other names
- alpha-galactosylceramide analogKRN7000 analogKRN-7000 analogKRN 7000 analog
02
Targets
CD1D (Tumor-associated macrophage/myeloid-derived suppressor cell CD1d complex)
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