Table 3.
Summary of biological activity results from the analytical similarity assessment of ABP 654 and ustekinumab (US and EU)
| Analytical testing/attribute | ABP 654 [range (n)] | Ustekinumab US [range (n)] | Ustekinumab EU [range (n)] |
|---|---|---|---|
| Inhibition of IL-23-mediated signaling (%)a | 89–116 (22) | 83–129 (16) | 94–124 (31) |
| IL-23 receptor-ligand binding (%)a | 88–120 (22) | 86–120 (16) | 85–124 (31) |
| Lack of binding to receptor bound IL-23 on cell surface | No binding (1) | No binding (1) | No binding (1) |
| IL-23 binding kinetics and affinity (KD, pM) | 103–104 (3) | 90–95 (3) | 95–99 (3) |
| Inhibition of IL-12-mediated signaling (%)a | 86–120 (22) | 86–121 (15) | 91–123 (31) |
| IL-12 receptor-ligand binding (%)a | 95–115 (22) | 98–122 (15) | 94–114 (31) |
| Lack of binding to receptor-bound IL-12 on cell surface | No binding (1) | No binding (1) | No binding (1) |
| IL-12 binding kinetics and affinity (KD, pM) | 61–62 (3) | 61–62 (3) | 60 (3) |
| Binding specificity against cytokines related to IL-23/IL-12 | No binding (1) | No binding (1) | No binding (1) |
| Binding to FcRn (%)a | 87–112 (22) | 78–106 (18) | 94–108 (33) |
| Lack of ADCC activity | No activity (1) | No activity (1) | No activity (1) |
| FcγRIIIa binding (%) | 74–109 (22) | 120–151 (7) | 115–158 (23) |
| Lack of CDC activity | No activity (1) | No activity (1) | No activity (1) |
| C1q binding (%)a | 91–110 (21) | 92–115 (10) | 86–107 (27) |
| Lack of ADCP activity | No activity (1) | No activity (1) | No activity (1) |
| FcγRIa binding (%) | 101–111 (3) | 104–110 (3) | 100–108 (3) |
| FcγRIIa binding (%) | 98–103 (3) | 87–114 (3) | 100–106 (3) |
| FcγRIIb binding (%) | 95–100 (3) | 84–104 (3) | 96–105 (3) |
| FcγRIIIb binding (%) | 101–109 (3) | 104–133 (3) | 116–127 (3) |
ADCC antibody-dependent cell-mediated cytotoxicity, ADCP antibody-dependent cellular phagocytosis, C1q the first subcomponent of the C1 complex of the classical pathway of complement activation, CDC complement-dependent cytotoxicity, EU European Union, FcRn neonatal Fc receptor, FcγR Fc gamma receptor, FcγRIa FcγR type Ia, FcγRIIa FcγR type IIa, FcγRIIb FcγR type IIb, FcγRIIIb FcγR type IIIb, IL interleukin, n number of lots tested, PFS prefilled syringe, US United States
a130 mg vial results included with PFS and 45 mg vial ustekinumab results