ENGLUMAFUSP ALFA
UNII U4T9GD9GR9

Substance Identification & Data

This profile provides standardized clinical and technical data for Englumafusp Alfa, uniquely identified by the FDA Unique Ingredient Identifier (UNII) U4T9GD9GR9.

Technical mappings include the Chemical Abstracts Service (CAS) Registry Number 2417199-08-5 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

U4T9GD9GR9

CAS Registry Number

2417199-08-5

RxNorm Concept ID

N/A

Detailed Substance Profile

Preferred Name

ENGLUMAFUSP ALFA

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

NCI Thesaurus

C169052

National Cancer Institute reference terminology for clinical and research data.

INN ID

11793

Sequential identifier assigned via the WHO International Nonproprietary Name program.

USAN ID

KL-61

Identifier assigned by the United States Adopted Names Council.

Substance Type

Englumafusp Alfa

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

Synonyms and Nomenclature

This section provides a complete list of nomenclature and identifier mappings for Englumafusp Alfa. 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

ENSOMAFUSP ALFA

Englumafusp Alfa

Common Names & Synonyms

71-248-4-1BB ligand (human precursor) fusion protein with peptide linker (GGGGS)2 fusion protein with 71-248-4-1BB ligand (human precursor) peptide linker (GGGGS)2 fusion protein with human κ-chain C region fusion protein with immunoglobulin G1 [497-alanine,498-alanine,592-glycine] (human γ1-chain C-region C-terminal fragment), disulfide with 71-248-4-1BB ligand (human precursor) fusion protein with peptide linker (GGGGS)2 fusion protein with human γ1-chain CH1 region, (489→230'),(492→233'),(617→353')-tris(disulfide) with immunoglobulin G1 [238-alanine,239-alanine,333-glycine] anti-(human CD19 antigen) (human monoclonal 8B8-2B11 γ1-chain) disulfide with human monoclonal 8B8-2B11 κ-chain

ENGLUMAFUSP ALFA [USAN]

ENSOMAFUSP ALFA [USAN]

Englumafusp alfa [WHO-DD]

englumafusp alfa [INN]

humanized immunoglobulin G1-kappa anti-(human B-lymphocyte antigen CD19) modified heterodimer where the heavy and light chain variable regions of one arm have been substituted by three subunits of human 4- 1BB ligand (tumor necrosis factor ligand superfamily member 9, TNFSF9) with the following structural arrangement: human 4-1BB ligand fragment (71-248, 1-178 in the current sequence) fused via peptidyl linker 179GGGGSGGGGS188 to human 4-1BB ligand fragment (71-248, 189-366 in the current sequence), fused via peptidyl linker 367GGGGSGGGGS376 to immunoglobulin G1 kappa light chain constant region (377-483) variant (E392>R, Q393>K), which is linked to immunoglobulin G1 heavy chain constant region (484-710) variant (L497>A, L498>A, P592>G, S617>C T629>W) and 483-291'-disulfide with human 4-1BB ligand fragment (71- 248, 1'-178' in the current sequence) fused via peptidyl linker 179'GGGGSGGGGS188' to the immunoglobulin G1 heavy chain constant region (189'-291') variant (K218>E K284>E), heterodimer with humanized immunoglobulin G1 anti- (human CD19) heavy chain (1''-452'') variant (L238>A, L239>A, P333>G, Y353>C, T370>S, L372>A, Y411>V), (224''-219''')-disulfide with immunoglobulin G1 anti-(human CD19) kappa light chain (1'''-219'''), produced in Chinese hamster ovary (CHO) cells, glycoform alfa; fusion protein with three copies of an extracellular domain fragment of the human 4-1BB ligand (tumor necrosis factor ligand superfamily member 9, TNFSF9), replacing the heavy chain and light chain variable regions of one arm of a modified humanized anti-[CD19 (Blymphocyte antigen CD19, B-lymphocyte surface antigen B4, T-cell surface antigen Leu-12)] immunoglobulin G1 (IgG1) kappa: 4-1BB ligand (71-248)-peptide (1-178) / (G4S)2 linker (179-188) / 4-1BB ligand (71-248)-peptide (189-366) / (G4S)2 linker (367-376) / IgG1 kappa light chain constant region (377-483) [Homo sapiens IGKC*01 (E392>R, Q393>K)] / IgG1 heavy chain constant region (484- 710) [Homo sapiens IGHG1*01; hinge: 484-493; CH2: 494-603 (L497>A, L498>A, P592>G), CH3: 604-708 (S617>C, T629>W); CHS: 709-710] fusion protein, (483- 291')-disulfide with 4-1BB ligand (71-248)-peptide (1'- 178') / (G4S)2 linker (179'-188') / IgG1 gamma-1 heavy chain constant region (189'-291') [Homo sapiens IGHG1*01; CH1: 189-286 (K218>E, K284>E)] fusion protein; heterodimer (489- 230'':492-233'':617-353K284>E)] fusion protein; heterodimer (489-230'':492- 233'':617-353'')- trisdisulfide with humanized anti-CD19 IgG1 heavy chain (1''-452'') [Homo sapiens IGHV1-2*02; Homo sapiens IGHJ4*01; Homo sapiens IGHG1*01; VH: 1-121; CH1: 122-219; hinge: 220-234; CH2: 235-344 (L238>A, L239>A, P333>G); CH3: 345-449 (Y353>C, T370>S, L372>A, Y411>V); CHS: 450-451; CDR Kabat H1: DYIMH (31-35); CDR Kabat H2: YINPYNDGSKYTEKFQG (50-66); CDR Kabat H3: GTYYYGPQLFDY (99- 110)], (224''-219''')-disulfide with humanized anti-CD19 IgG1 kappa light chain (1'''-219''') [Homo sapiens IGKV2- 29*02; Homo sapiens IGKJ2*01; Homo sapiens IGKC*01; VL: 1-112;

humanized immunoglobulin G1-kappa anti-(human B-lymphocyte antigen CD19) modified heterodimer where the heavy and light chain variable regions of one arm have been substituted by three subunits of human 4- 1BB ligand (tumor necrosis factor ligand superfamily member 9, TNFSF9) with the following structural arrangement: human 4-1BB ligand fragment (71-248, 1-178 in the current sequence) fused via peptidyl linker 179GGGGSGGGGS188 to human 4-1BB ligand fragment (71-248, 189-366 in the current sequence), fused via peptidyl linker 367GGGGSGGGGS376 to immunoglobulin G1 kappa light chain constant region (377-483) variant (E392>R, Q393>K), which is linked to immunoglobulin G1 heavy chain constant region (484-710) variant (L497>A, L498>A, P592>G, S617>C T629>W) and 483-291'-disulfide with human 4-1BB ligand fragment (71-248, 1'-178' in the current sequence) fused via peptidyl linker 179'GGGGSGGGGS188' to the immunoglobulin G1 heavy chain constant region (189'-291') variant (K218>E K284>E), heterodimer with humanized immunoglobulin G1 anti- (human CD19) heavy chain (1''-452'') variant (L238>A, L239>A, P333>G, Y353>C, T370>S, L372>A, Y411>V), (224''-219''')-disulfide with immunoglobulin G1 anti-(human CD19) kappa light chain (1'''-219'''), produced in Chinese hamster ovary (CHO) cells, glycoform alfa; fusion protein with three copies of an extracellular domain fragment of the human 4-1BB ligand (tumor necrosis factor ligand superfamily member 9, TNFSF9), replacing the heavy chain and light chain variable regions of one arm of a modified humanized anti-[CD19 (B-lymphocyte antigen CD19, B-lymphocyte surface antigen B4, T-cell surface antigen Leu-12)] immunoglobulin G1 (IgG1) kappa: 4-1BB ligand (71-248)-peptide (1-178) / (G4S)2 linker (179-188) / 4-1BB ligand (71-248)-peptide (189-366) / (G4S)2 linker (367-376) / IgG1 kappa light chain constant region (377-483) [Homo sapiens IGKC*01 (E392>R, Q393>K)] / IgG1 heavy chain constant region (484-710) [Homo sapiens IGHG1*01; hinge: 484-493; CH2: 494-603 (L497>A, L498>A, P592>G), CH3: 604-708 (S617>C, T629>W); CHS: 709-710] fusion protein, (483-291')-disulfide with 4-1BB ligand (71-248)-peptide (1'- 178') / (G4S)2 linker (179'- ENSOMAFUSP ALFA March 30, 2022 N22/49 Page 2 of 3 188') / IgG1 gamma-1 heavy chain constant region (189'-291') [Homo sapiens IGHG1*01; CH1: 189-286 (K218>E, K284>E)] fusion protein; heterodimer (489-230'':492-233'':617-353K284>E)] fusion protein; heterodimer (489-230'':492-233'':617-353'')- trisdisulfide with humanized anti-CD19 IgG1 heavy chain (1''-452'') [Homo sapiens IGHV1-2*02; Homo sapiens IGHJ4*01; Homo sapiens IGHG1*01; VH: 1-121; CH1: 122-219; hinge: 220-234; CH2: 235-344 (L238>A, L239>A, P333>G); CH3: 345-449 (Y353>C, T370>S, L372>A, Y411>V); CHS: 450-451; CDR Kabat H1: DYIMH (31-35); CDR Kabat H2: YINPYNDGSKYTEKFQG (50-66); CDR Kabat H3: GTYYYGPQLFDY (99- 110)], (224''-219''')-disulfide with humanized anti-CD19 IgG1 kappa light chain (1'''-219''') [Homo sapiens IGKV2-29*02; Homo sapi