Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2854 |
| INN | Verenafusp alfa |
| Status | Clinical |
| Drug code(s) | GNR-055 |
| Brand name | None |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Immunoconjugate |
| Format, general category | Fragment fusion |
| Format details | None |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | IDS |
| Discovery method/technology | None |
| Target(s) | Insulin receptor |
| Indications of clinical studies | Mucopolysaccharidosis Type II |
| Primary therapeutic area | Metabolic disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 15, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | November 30, 2021 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | AO GENERIUM |
| Licensee/Partner | None |
| Comments about company or candidate | NCT05208281 Phase 2/3 started in Nov 2021 NCT04539340 Phase 1 started in Feb 2020 |
| Full address of company | 123112 Moscow, Testovskaya str., 10, entrance 2 Europe Russia https://www.generium.ru/en/contacts/ |
chimeric immunoglobulin G1-kappa antigen-binding fragment (Fab) anti-[human insulin receptor (INSR)] fused at the C-terminus of the heavy chain via peptide linker 221LSS223 to human iduronate-2- sulfatase fragment, glycoform alfa;
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |