Table 3.
Engineered antibody drugs in phase II, phase III clinical trials or approved.
| International drug code | Company/sponsor | Type/source | Target antigen | Progress status | Disorder(s) | Administration route |
|---|---|---|---|---|---|---|
| Nivolumab (OPDIVO) | Bristol-Myers Squibb | Human IgG4 monoclonal antibody | Programmed cell death protein 1 (PD-1) | Approved (2017) | Locally advanced or metastatic urothelial carcinoma | IV |
| Necitumumab (Portrazza) | Eli Lilly and Company | Humanized IgG1 monoclonal antibody | Epidermal Growth Factor Receptor (EGFR) | Approved (2015) | Cancer (NSCLC) | IV |
| Ramucirumab (Cyramza) | Eli Lilly and Company | Human IgG1 monoclonal antibody | Vascular endothelial growth factor receptor 2 (VEGFR2) | Approved (2015) | Cancer (NSCLC, breast, metastatic gastric adenocarcinoma) | IV |
| Raxibacumab (ABthrax) | CAT technology and Human Genome Sciences- GlaxoSmithKline | Recombinant Human IgG1λ Monoclonal Antibody | Protective antigen (PA) component of anthrax (Bacillus anthracis) | Approved (2012) | Prophylaxis, anthrax | Oral or IV |
| Ipilimumab (Yervoy) | Bristol-Myers Squibb | Human IgG1κ monoclonal antibody | Human cytotoxic T-lymphocyte antigen 4 (CTLA-4) | Approved (2011) | Melanoma, Metastatic | IV |
| Belimumab (Benlysta) | GlaxoSmithKline | Recombinant human IgG1λ monoclonal antibody | B-lymphocyte stimulator (BLyS) | Approved (2011) | Autoantibody-positive, systemic lupus | IV |
| Ecallantide (Kalbitor) | Dyax Corp. | human IgG1 monoclonal antibody | Plasma kallikrein | Approved (2009) | Hereditary angioedema | SI |
| Romiplostim (Nplate) | Amgen Inc. | Peptide-Fc fusions or peptibody | Thrombopoietin receptor (TPOR) | Approved (2008) | Immune thrombocytopenic purpura | SI |
| Ranibizumab (Lucentis) | Genentech | Recombinant humanized IgG1κ monoclonal antibody fragment | Vascular endothelial growth factor A (VEGF-A) | Approved (2006) | Neovascular (wet) age-related macular degeneration | Intravitreal injection |
| Adalimumab (Humira) | Abbott Laboratories | Recombinant human IgG1 monoclonal antibody | Tumor necrosis factor-α (TNF) | Approved (2002) | Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, crohn's disease, ulcerative colitis, plaque psoriasis | SI |
| Solofuse (Xyntha) | Wyeth Pharmaceuticals/ Pfizer | Recombinant factor VIII product | Factor VIII | Approved (2008) | Hemophilia A | IV |
| Guselkumab (CNTO 1959) | MorphoSys/Janssen Biotech | Human IgG1 monoclonal antibody | Interleukin 23 (IL-23p19) | Phase III | Psoriasis | IV or SI |
| Gantenerumab | Roche | Human IgG1 monoclonal antibody | Beta-amyloid | Phase III | Alzheimer | IV or SI |
| Trebananib (AMG 386) | Amgen Inc. | Angiopoietin 1/2-neutralizing peptibody | Angiopoietin 1 and 2 neutralizing peptibody (Ang1/2) | Phase III | Cancer (ovarian, peritoneal, fallopian tube) | IV |
| Foravirumab (CL-184) | Sanofi/Crucell | Human IgG1κ monoclonal antibody | Rabies virus glycoprotein | Phase III | Prophylaxis, inhaled anthrax | IV |
| Bimagrumab (BYM338) | Novartis Pharmaceuticals | Human IgG1λ monoclonal antibody | Activin receptor IIB (ActRIIB) | Phase IIb/III | Pathological muscle loss and weakness | IV |
| ZMapp | Mapp Biopharmaceutical, Inc. | Chimeric monoclonal antibody cocktail of MB-003, ZMab, c2G4 and c4G7 | Ebola virus protein sGP | Phase II | Ebola virus disease (EVD) | IV |
| GRN1005 | Angiochem Inc. | Peptide-drug conjugate | Lipoprotein receptor protein-1 | Phase II | Non-small Cell Lung Cancer (NSCLC) With Brain Metastases | IV |
| Ganitumab (AMG 479) | Amgen Inc. | Human IgG1 monoclonal antibody | Insulin-like growth factor receptor (IGF-1R) | Phase II | Cancer (pancreatic, colorectal breast, NSCLC) | IV |
| Cixutumumab (IMC-A12) | Eli Lilly and Co. | Human IgG1 monoclonal antibody | Insulin-like growth factor-1 receptor (IGF-1R) | Phase II | Cancer (NSCLC, metastatic melanoma of the eye, liver) | IV |
| MM-121 | Merrimack Pharmaceutical partner with Sanofi | Human IgG2 monoclonal antibody | ErbB3 gene | Phase II | Cancer (advanced ovarian, hormone sensitive breast cancer, NSCLC, and HER2 negative neoadjuvant breast cancer) | IV |
| BIIB 033 | Biogen Idec | Human aglycosyl IgG1 monoclonal antibody | Leucine-rich repeat and immunoglobulin-like domain containing, Nogo receptor-interacting protein (LINGO 1) | Phase II | Acute optic neuritis, MS | IV |
| Mapatumumab | GSK company | Human IgG1 monoclonal antibody | TNF-related apoptosis-inducing ligand receptor 4 (TRAIL-4) | Phase II | Cancer (NSCLC, non-Hodgkin lymphoma, liver, cervical) | IV |
| Tralokinumab (CAT-354) | AstraZeneca | Human IgG4 monoclonal antibody | Interleukin-13 | Phase IIb | Ulcerative colitis, pulmonary fibrosis, asthma | SI |
| Mavrilimumab (CAM-3001) | MedImmune | Human IgG4 monoclonal antibody | Granulocyte macrophage-colony stimulating factor receptor (GM-CSF) | Phase IIb | Rheumatoid arthritis | IV |
| Bertilimumab | Immune Pharmaceuticals | Human IgG4 monoclonal antibody | Eotaxin-1 (CCL-11 gene) | Phase II | Ulcerative colitis | IV |
| GSK3196165 (MOR103) | MorphoSys/ GSK company | Recombinant Human IgG1 monoclonal antibody | Granulocyte macrophage colony-stimulating factor (GM-CSF) | Phase II | Inflammatory diseases (rheumatoid arthritis) | IV |
| BHQ880 | Novartis Pharmaceuticals | Human IgG1 monoclonal antibody | Dickkopf-1 (DKK1 gene) | Phase II | Multiple myeloma | IV |
| Carlumab (CNTO 888) | Centocor Research & Development, Inc. | Human IgG1κ monoclonal antibody | Monocyte Chemoattractant Protein-1 (MCP-1), CCL-2 gene | Phase II | Prostate cancer | IV |
| MLDL1278A (BI-204) | Genentech/ Bioinvent | Recombinant Human IgG1 antibody | Oxidized low-density lipoprotein (LDL) | Phase II | Stable atherosclerotic vascular disease | IV or SC |
| Adecatumumab (MT201) | Amgen Inc. | Recombinant Human IgG1 monoclonal antibody | Epithelial cell adhesion molecule (EpCAM) | Phase II | Colorectal cancer (CRC), liver and breast metastases | IV |
| Fresolimumab (GC-1008) | Sanofi/Genzyme | Human IgG4 monoclonal antibody/immunomodulator | Transforming growth factor-beta (TGF-β) 1, 2, and 3 | Phase II | Primary brain tumors, primary focal segmental glomerulosclerosis, diopathic pulmonary fibrosis, cancer | IV |
| BI-505 | BioInvent | Human IgG1 monoclonal antibody | Intercellular Adhesion Molecule 1 (ICAM-1) or Cluster of Differentiation 54 (CD54) | Phase II | Cancer (multiple myeloma) | IV |
NSCLC, non-small cell lung cancer; IV, intravenous; SI, subcutaneous injection; IM-intramuscular injection.