Table 3.
Current status of innovative antibody, Fc fusion protein, and chimeric antigen receptor (CAR) drug candidates*
| Antibody format | Stage of development | Totals | ||
|---|---|---|---|---|
| Phase I/II | Phase III | Approved for marketing at some point** | ||
| Naked IgG | 30 | 51 | 52 | 493 |
| Naked antibody fragments | 7 | 2 | 4 | 13 |
| Immunocytokines | 9 | 2 | 0 | 11 |
| Fc fusion proteins | 23 | 3 | 11 | 37 |
| Bispecific antibodies | 58 | 1 | 2 | 61 |
| • IgG-like | • (41) | • (1) | • (1) | • (43) |
| • Fragment-based | • (14) | • (0) | • (1) | • (15) |
| • Nanoparticle*** | • (03) | • (0) | • (0) | • (03) |
| Antibody-drug conjugates# | 75 | 9 | 3 | 87 |
| Radioimmunoglobulins | 13 | 2 | 2 | 17 |
| Antibodies only | 575 | 70 | 74 | 719 |
| T or NK cells expressing CAR antibodies | 145 | 0 | 0 | 145 |
| Totals | 720 | 70 | 74 | 864 |
Abbreviations: IgG, immunoglobulin G; CAR, chimeric antigen receptor
* From BiStro Biotech Consulting database on clinical stage biologics. Database lock for these data was April 30, 2017
** Innovative antibodies and Fc fusion proteins approved for marketing in a major market (US, EU, Japan)
Five (Raptiva®, 2009; Mylotarg®, 2010; Orthoclone OKT3®, 2011; Bexxar®, 2014; Removab®, 2017) have been withdrawn from marketing, and two others were withdrawn and subsequently were re-approved for new indications under different trade names
*** Bispecific EGFR x Escherichia coli O-polysaccharide tandem single chain, Fragment variable (scFv) antibodies that target minicell-derived nanoparticles to tumors
# The 87 antibody-drug conjugates are comprised of 68 small molecule cytotoxic drugs, 10 proteins, and 9 not described