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| Stem definition | Drug id | CAS RN |
|---|---|---|
| rat origin | 5706 | 2119595-80-9 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Teclistamab is a full-size, IgG4-PAA bispecific antibody that targets the CD3 receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. With its dual binding sites, teclistamab is able to draw CD3+ T cells in close proximity to BCMA+ cells, resulting in T cell activation and subsequent lysis and death of BCMA+ cells, which is mediated by secreted perforin and various granzymes stored in the secretory vesicles of cytotoxic T cells. This effect occurs without regard to T cell receptor specificity or reliance on major histocompatibility complex (MHC) Class 1 molecules on the surface of antigen presenting cells.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 23, 2022 | EMA | JANSSEN-CILAG INTERNATIONAL N.V. | |
| Oct. 25, 2022 | FDA | JANSSEN BIOTECH |
| 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 | 906.94 | 42.96 | 187 | 1657 | 27786 | 90598817 |
| Immune effector cell-associated neurotoxicity syndrome | 411.16 | 42.96 | 75 | 1769 | 5693 | 90620910 |
| Hypogammaglobulinaemia | 70.78 | 42.96 | 20 | 1824 | 10654 | 90615949 |
| Progressive multifocal leukoencephalopathy | 67.40 | 42.96 | 21 | 1823 | 15634 | 90610969 |
| Intervertebral discitis | 61.57 | 42.96 | 15 | 1829 | 4505 | 90622098 |
| Respiratory tract infection | 58.40 | 42.96 | 27 | 1817 | 59051 | 90567552 |
| COVID-19 | 57.09 | 42.96 | 38 | 1806 | 168805 | 90457798 |
| Death | 56.32 | 42.96 | 57 | 1787 | 456494 | 90170109 |
| 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 | 737.44 | 41.98 | 213 | 2273 | 44314 | 42574535 |
| Immune effector cell-associated neurotoxicity syndrome | 241.59 | 41.98 | 64 | 2422 | 9397 | 42609452 |
| IVth nerve paralysis | 133.25 | 41.98 | 24 | 2462 | 567 | 42618282 |
| IgA nephropathy | 131.67 | 41.98 | 30 | 2456 | 2344 | 42616505 |
| COVID-19 | 128.01 | 41.98 | 81 | 2405 | 115867 | 42502982 |
| Device related sepsis | 69.90 | 41.98 | 20 | 2466 | 3867 | 42614982 |
| Ureteric haemorrhage | 49.53 | 41.98 | 9 | 2477 | 223 | 42618626 |
| Hepatitis fulminant | 48.55 | 41.98 | 16 | 2470 | 4943 | 42613906 |
| Hypogammaglobulinaemia | 48.00 | 41.98 | 20 | 2466 | 11871 | 42606978 |
| Pneumonia | 45.68 | 41.98 | 85 | 2401 | 422064 | 42196785 |
| COVID-19 pneumonia | 42.26 | 41.98 | 22 | 2464 | 21591 | 42597258 |
| 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 | 1274.76 | 34.77 | 327 | 3702 | 69979 | 110515291 |
| Immune effector cell-associated neurotoxicity syndrome | 466.50 | 34.77 | 108 | 3921 | 14674 | 110570596 |
| COVID-19 | 163.89 | 34.77 | 105 | 3924 | 244955 | 110340315 |
| IVth nerve paralysis | 141.87 | 34.77 | 24 | 4005 | 635 | 110584635 |
| IgA nephropathy | 136.99 | 34.77 | 30 | 3999 | 3143 | 110582127 |
| Hypogammaglobulinaemia | 109.07 | 34.77 | 37 | 3992 | 20039 | 110565231 |
| COVID-19 pneumonia | 86.92 | 34.77 | 37 | 3992 | 37106 | 110548164 |
| Pneumonia | 84.20 | 34.77 | 129 | 3900 | 876585 | 109708685 |
| Progressive multifocal leukoencephalopathy | 75.91 | 34.77 | 30 | 3999 | 24926 | 110560344 |
| Device related sepsis | 65.80 | 34.77 | 20 | 4009 | 7627 | 110577643 |
| Pyrexia | 64.39 | 34.77 | 116 | 3913 | 898149 | 109687121 |
| Adverse reaction | 61.12 | 34.77 | 27 | 4002 | 29567 | 110555703 |
| Ureteric haemorrhage | 57.50 | 34.77 | 9 | 4020 | 144 | 110585126 |
| Sepsis | 54.11 | 34.77 | 63 | 3966 | 327283 | 110257987 |
| Intervertebral discitis | 50.53 | 34.77 | 16 | 4013 | 6974 | 110578296 |
| Plasma cell myeloma | 49.53 | 34.77 | 30 | 3999 | 62906 | 110522364 |
| Hepatitis fulminant | 47.35 | 34.77 | 16 | 4013 | 8544 | 110576726 |
| Respiratory tract infection | 45.97 | 34.77 | 30 | 3999 | 71587 | 110513683 |
| Death | 43.37 | 34.77 | 85 | 3944 | 698784 | 109886486 |
| Plasmacytoma | 42.03 | 34.77 | 13 | 4016 | 5249 | 110580021 |
| Cytomegalovirus infection reactivation | 42.00 | 34.77 | 18 | 4011 | 18315 | 110566955 |
| Plasma cell myeloma refractory | 39.30 | 34.77 | 10 | 4019 | 1991 | 110583279 |
| Bacterial sepsis | 36.90 | 34.77 | 14 | 4015 | 10412 | 110574858 |
| Tachypnoea | 36.83 | 34.77 | 21 | 4008 | 39374 | 110545896 |
| Campylobacter test positive | 36.30 | 34.77 | 6 | 4023 | 137 | 110585133 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX24 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| MeSH PA | D000074322 | Antineoplastic Agents, Immunological |
| MeSH PA | D000970 | Antineoplastic Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsed or refractory multiple myeloma | indication | 109989006 | DOID:9538 |
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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 | ANTIBODY BINDING | Kd | 7.55 | DRUG LABEL | DRUG LABEL | |||
| Tumor necrosis factor receptor superfamily member 17 | Tumour-associated antigen | ANTIBODY BINDING | Kd | 9.74 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757981 | CHEBI |
| CHEMBL4594505 | ChEMBL_ID |
| C000731928 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12233 | IUPHAR_LIGAND_ID |
| DB16655 | DRUGBANK_ID |
| 278171000202105 | SNOMEDCT_US |
| 4041792 | VANDF |
| 4041793 | VANDF |
| C5235398 | UMLSCUI |
| 10928 | INN_ID |
| D12177 | KEGG_DRUG |
| 362676 | MMSL |
| 41040 | MMSL |
| d09938 | MMSL |
| 019216 | NDDF |
| 54534MX6Z9 | UNII |
| 2619425 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TECVAYLI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-449 | INJECTION | 10 mg | SUBCUTANEOUS | BLA | 31 sections |
| TECVAYLI | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-450 | INJECTION | 90 mg | SUBCUTANEOUS | BLA | 31 sections |