Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 207 |
| INN | Ulviprubart |
| Status | Clinical |
| Drug code(s) | ABC008 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | KLRG1 |
| Indications of clinical studies | Inclusion Body Myositis, T-cell Large Granular Lymphocytic Leukemia |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 2/3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | May 25, 2021 |
| Start of Phase 2 | September 15, 2022 |
| Start of Phase 3 | February 15, 2023 |
| 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 | Abcuro Inc. |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06450886 Phase 2/3 in Inclusion Body Myositis due to start in Sep 2024 NCT05721573 Phase 2/3 in Inclusion Body Myositis started in Feb 2023. NCT05532722 Phase 1/2 started in Sep 2022. NCT04659031 Phase 1 started in May 2021. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Designation to ABC008 for the treatment of IBM. |
| Full address of company | 55 Chapel St Suite 200, Newton, MA 02458, United States North America United States of America https://abcuro.com/ |
ABC008 is a humanized, afucosylated anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |