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| 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 |
|---|---|---|---|
| Jan. 25, 2022 | FDA | IMMUNOCORE LTD | |
| April 1, 2022 | EMA | IMMUNOCORE IRELAND LIMITED |
| 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 | 145.67 | 69.16 | 27 | 133 | 27946 | 90600341 |
| 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 | 95.68 | 65.84 | 24 | 146 | 44503 | 42576662 |
| 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 | 185.35 | 64.17 | 40 | 206 | 70266 | 110518787 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01XX75 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| MeSH PA | D000970 | 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 |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| 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 |
|---|---|
| CHEBI:757417 | CHEBI |
| CHEMBL4297990 | ChEMBL_ID |
| C000719808 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7378 | IUPHAR_LIGAND_ID |
| DB15283 | DRUGBANK_ID |
| 1025311000122109 | SNOMEDCT_US |
| 4041128 | VANDF |
| 4041129 | VANDF |
| C5139666 | UMLSCUI |
| CHEMBL2109434 | ChEMBL_ID |
| D12296 | KEGG_DRUG |
| 10664 | INN_ID |
| 355621 | MMSL |
| 40399 | MMSL |
| d09847 | MMSL |
| 018939 | NDDF |
| N658GY6L3E | UNII |
| 2590743 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| KIMMTRAK | HUMAN PRESCRIPTION DRUG LABEL | 1 | 80446-401 | INJECTION, SOLUTION, CONCENTRATE | 100 ug | INTRAVENOUS | BLA | 27 sections |