Omidubicel

Omidubicel is a nicotinamide (NAM) modified allogeneic hematopoietic progenitor cell therapy derived from cord blood used as an allogeneic stem cell donor source. Omidubicel is manufactured utilizing a proprietary NAM based technology producing enriched HPCs.

NAM technology overcomes the induction of accelerated proliferation, differentiation, cellular stress and signaling pathways that are typically activated when HPCs are removed from their natural environment.

Ex-vivo culturing of cord blood derived HPCs in the presence of NAM leads to preservation of their stemness, homing to the bone marrow (BM) and retained engraftment capacity as demonstrated by rapid neutrophil engraftment and multi lineage immune reconstitution as observed in the clinical trials with omidubicel.

Transplantation with omidubicel resulted in rapid and broad immune reconstitution of dendritic cells, monocytes, Natural Killer (NK), CD4+ T cells and CD8+ T cells as early as one-week post-transplantation, and B cells 28 days post transplantation and all lineages throughout the one-year follow-up period. Robust positive linear correlations between the CD34( + ) cell content in the omidubicel, and the reconstitution of T-cells and NK cells were identified. Additionally, dose-response analyses demonstrated a strong correlation between the total CD34+ cell counts and dose/kg for omidubicel with the kinetics of neutrophil recovery. The model demonstrated that days to neutrophil recovery decreased with an increase in omidubicel CD34( + ) cell dose.

Omidubicel is a cryopreserved nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood. The nature of omidubicel is such that conventional pharmacokinetic studies on absorption, distribution, metabolism, and excretion are not applicable.