UMITRELIMORGENE AUTODENCEL
UNII N4PY4N58R9

Substance Identification & Data

This profile provides standardized clinical and technical data for Umitrelimorgene Autodencel, uniquely identified by the FDA Unique Ingredient Identifier (UNII) N4PY4N58R9.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number N/A and the RxNorm Concept ID (RxCUI) N/A. Explore the sections below for detailed nomenclature and a complete directory of NDC-listed products containing this ingredient.

FDA UNII Code

N4PY4N58R9

CAS Registry Number

N/A

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

UMITRELIMORGENE AUTODENCEL

Official standardized name for this substance within the FDA UNII nomenclature system.

NCI Thesaurus

C203189

National Cancer Institute reference terminology for clinical and research data.

INN ID

12276

Sequential identifier assigned via the WHO International Nonproprietary Name program.

Substance Type

Umitrelimorgene Autodencel

ISO 11238 classification category (e.g., Chemical, Polymer, Protein).

ITIS TSN

180092

Taxonomic Serial Number for species identified in the Integrated Taxonomic Information System.

NCBI Taxonomy

9606

Unique numeric identifier used to specify biological species in the NCBI database.

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Umitrelimorgene Autodencel. Identifiers are organized into official regulatory terms, commercial trade names, and technical systematic synonyms used to ensure accurate identification across clinical pharmaceutical databases, regulatory filings, and electronic health records.

FDA Official Name

Umitrelimorgene Autodencel

Common Names & Synonyms

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]

External Clinical & Regulatory Resources

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