Table 2.
Bispecific antibody candidates under clinical evaluation.
| Format | Strategy | Target | Clinical development phase | Disease | Company | |
|---|---|---|---|---|---|---|
| bsAb/bsAb Fragment | ||||||
| Catumaxomab | Triomab | Quadroma | EpCAM × CD3 | Approved by European Medicines Agency Phase-2 (NCT00189345) Phase-2 (NCT01504256) Phase-2 (NCT01246440) |
EpCAM+ tumor; malignant ascites Platinum refractory epithelial ovarian carcinoma Gastric adenocarcinoma Ovarian cancer |
Neovii Biotech AGO Study Group AIO-Studien-gGmbH Grupo Espanol de Investigacion en Cancer de Ovario |
| Ertumaxomab | Triomab | Quadroma | HER2 × CD3 | Phase-1/2 (NCT01569412) Phase-2 (NCT00351858) Phase-2 (NCT00452140) Phase-2 (NCT00522457) |
Her2/Neu+ advanced solid tumor Advanced metastatic breast cancer |
Krankenhaus Nordwest Neovii Biotech |
| FBTA05 | Triomab | Quadroma | CD20 × CD3 | Phase-1/2 (NCT01138579) | CLL | Technische Universitat Munchen |
| RO695688 | Crossmab | Knobs-in-holes (KiH) | CEA × CD3 | Phase-1 (NCT02324257) | Advanced metastatic CEA+ solid tumors | Hoffmann-La Roche |
| RO5520985 | Crossmab | KiH | Ang2 × VEGFA | Phase-1 (NCT01688206) | Advanced or metastatic solid tumors | Hoffmann-LA Roche |
| RO5520985 | Crossmab | KiH | Ang2 × VEGFA | Phase-2 (NCT01688206) Phase-2 (NCT02484690) |
Advanced or metastatic solid tumors AMD |
Hoffmann-La Roche Hoffmann-La Roche |
| RG7813 | scFv-IgG | NA | CEA × IL-2 | Phase-1 (NCT02004106) | Advanced metastatic CEA+ solid tumors | |
| MM-141 | scFv-IgG | NA | IGF × HER3 | Phase-1 (NCT01733004) Phase-2 (NCT02399137) |
Advanced solid tumor Metastatic pancreatic cancer |
Merrimack Pharmaceuticals Merrimack Pharmaceuticals |
| MOR209/ES414 | scFv-IgG | NA | PSMA × CD3 | Phase-1 (NCT02262910) | Metastatic prostate cancer | Aptevo Therapeutics |
| LY3164530 | Ortho-Fab IgG | Structural optimization | MET × EGFR | Phase-1 (NCT02221882) | Metastatic neoplasm | Eli Lilly and Company |
| ALX-0061 | Nanobody | NA | IL-6R × HSA | Phase-2 (NCT01284569) | Rheumatoid arthritis | Ablynx |
| ATN-103 | Nanobody | NA | TNF × HSA | Phase-2 (NCT01063803) | Rheumatoid arthritis | Ablynx |
| Blinatumomab | Bispecific T-cell engager BiTE | NA | CD3 × CD19 | Approved by Food and Drug Administration Phase-1 (NCT00274742) Phase-2 (NCT01207388) Phase-2 (NCT01209286) Phase-1 (NCT02568553) Phase-2 (NCT02143414) Phase-3 (NCT02003222) |
ALL Relapsed NHL Residual ALL Relapsed/refractory ALL Relapsed NHL ALL BCR-ABL−/− B-cell lineage ALL |
Amgen GmbH Amgen GmbH Amgen GmbH Amgen GmbH National Cancer Institute National Cancer Institute National Cancer Institute |
| Solitomab | BiTE | NA | CD3 × EpCAM | Phase-1 (NCT00635596) | Advanced solid tumors | Amgen GmbH |
| AMG330 | BiTE | NA | CD33 × CD3 | Phase-1 (NCT02520427) | AML | Amgen GmbH |
| MT112 (BAY2010112) | BiTE | NA | PSMA × CD3 | Phase-1 (NCT01723475) | Castration resistant prostate cancer | Bayer |
| MT111 (MEDI-565) | BiTE | NA | CEA × CD3 | Phase-1 (NCT01284231) | Advanced gastrointestinal adenocarcinoma | Medimmune LLC |
| AFM11 | Tandem diabody (Tandab) | NA | CD19 × CD3 | Phase-1 (NCT02106091) | CD19+ B-cell NHL | Affimed GmbH |
| AFM13 | Tandab | NA | CD30 × CD16A | Phase-2 (NCT02321592) | Relapsed/refractory Hodgkin’s lymphoma | Affimed GmbH |
| rM28 | Tandab | NA | CD28 × MAPG | Phase-2 (NCT00204594) | Metastatic melanoma | University Hospital, Tuebingen |
| MGD006 | Dual-affinity-retargeting (DART) | NA | CD3 × CD123 | Phase-1 (NCT02152956) | Relapsed/refractory AML | MacroGenics |
| MGD007 | DART | NA | CD3 × gpA33 | Phase-1 (NCT02248805) | Metastatic colorectal carcinoma | MacroGenics |
| MGD010 | DART | NA | CD32B × CD79B | Phase-1 (NCT02376036) | Healthy subjects | MacroGenics |
Abbreviations: CLL, chronic lymphocytic leukemia; AMD, age-related macular degeneration; CEA, carcinoembryonic antigen; ALL, acute lymphocytic leukemia; NHL, non-Hodgkin’s lymphoma; AML, acute myeloid leukemia; NA, information not available.
Source: https://clinicaltrials.gov/ct2/home.