UMITRELIMORGENE AUTODENCEL

UNII:	N4PY4N58R9
Type:	INGREDIENT SUBSTANCE
Formula:
Preferred Substance Name:	UMITRELIMORGENE AUTODENCEL
GSRS Full Record:	N4PY4N58R9 i

Umitrelimorgene Autodencel
autologous dendritic cells (DCs) derived from peripheral blood mononuclear cells (PBMCs) obtained from newly diagnosed glioblastoma multiforme patients by apheresis, loaded with two messenger ribonucleic acids (mRNA) encoding (i) human lysosome-associated membrane protein 1 (LAMP 1) fused in frame to codon-optimised human cytomegalovirus (hCMV) 65 kDa matrix protein (pp65) (LAMP:pp65) and (ii) amino acids 21-261 of codon-optimised CD-40 ligand (CD-40L M21). Each mRNA also contains a 5' cap (cap 0), a Kozak sequence and a 3' polyadenylation tail and The cells are expanded in selective growth media containing granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin 4 (IL-4). Prior to the electroporation, the cells are briefly cultured in a maturation media containing TNF-alpha, interferon-gamma (IFN-γ) and prostaglandin E 2 (PGE2). The cell suspension contains ≥60% dendritic cells (HLA-DR) and ≤10% each of T lymphocytes (CD3), B lymphocytes (CD19), natural killer cells (CD56) and monocytes (CD14). In a co-culture assay with T lymphocytes from the same patient the cells release IFN-γ
umitrelimorgene autodencel [INN]

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UNIIs are generated based on scientific identity characteristics using ISO 11238 data elements. UNII availability does not imply any regulatory review or approval. Synonyms and mappings are based on the best public information available at the time of publication. Please report any problems/errors associated with this data to FDA-SRS@fda.hhs.gov.

UMITRELIMORGENE AUTODENCEL

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