Stem definition | Drug id | CAS RN |
---|---|---|
fusion proteins | 5513 | 1874157-95-5 |
Molecule | Description |
---|---|
Synonyms:
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Tebentafusp-tebn is a bispecific gp100 peptide-HLA-A02:01 directed T cell receptor CD3 T cell engager. The TCR arm binds to a gp100 peptide presented by human leukocyte antigen-A*02:01 (HLA¬ A02:01) on the cell surface of uveal melanoma tumor cells. In vitro, tebentafusp-tebn bound to HLA-A02:01-positive uveal melanoma cells and activated polyclonal T cells to release inflammatory cytokines and cytolytic proteins, which results in direct lysis of uveal melanoma tumor cells.
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Date | Agency | Company | Orphan |
---|---|---|---|
April 1, 2022 | EMA | IMMUNOCORE IRELAND LIMITED | |
Jan. 25, 2022 | FDA | IMMUNOCORE LTD |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Cytokine release syndrome | 110.97 | 86.22 | 18 | 53 | 14296 | 63474655 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Cytokine release syndrome | 57.77 | 55.77 | 12 | 49 | 22865 | 34934005 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Cytokine release syndrome | 138.85 | 61.13 | 26 | 89 | 35972 | 79708301 |
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Source | Code | Description |
---|---|---|
ATC | L01XX75 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
FDA MoA | N0000175617 | CD3-directed Antibody Interactions |
FDA MoA | N0000175618 | CD3 Receptor Agonists |
FDA EPC | N0000193989 | Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager |
FDA MoA | N0000193994 | Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Unresectable uveal melanoma | indication | ||
Metastatic uveal melanoma | indication |
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Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
T-cell surface glycoprotein CD3 | Surface antigen | BINDING AGENT | Kd | 7.42 | DRUG LABEL | DRUG LABEL | |||
gp100 peptide‐HLA‐A*02:01 complex | Surface antigen | BINDING AGENT | Kd | 10.62 | DRUG LABEL | DRUG LABEL |
ID | Source |
---|---|
CHEMBL4297990 | ChEMBL_ID |
C000719808 | MESH_SUPPLEMENTAL_RECORD_UI |
7378 | IUPHAR_LIGAND_ID |
DB15283 | DRUGBANK_ID |
018939 | NDDF |
4041128 | VANDF |
4041129 | VANDF |
C5139666 | UMLSCUI |
CHEMBL2109434 | ChEMBL_ID |
D12296 | KEGG_DRUG |
10664 | INN_ID |
2590743 | RXNORM |
355621 | MMSL |
40399 | MMSL |
d09847 | MMSL |
N658GY6L3E | UNII |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
KIMMTRAK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80446-401 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | BLA | 29 sections |
KIMMTRAK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80446-401 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | BLA | 29 sections |