Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1242 |
| INN | Riliprubart |
| Status | Clinical |
| Drug code(s) | SAR445088, BIVV020 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Complement C1s |
| Indications of clinical studies | Chronic Inflammatory Demyelinating Polyneuropathy, Transplant Rejection, autoimmune Haemolytic Anaemia, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Cold Agglutinin Disease |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 15, 2019 |
| Start of Phase 2 | March 05, 2021 |
| Start of Phase 3 | March 28, 2024 |
| 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 | Sanofi |
| Licensee/Partner | None |
| Comments about company or candidate | NCT06290128 in Inflammatory Demyelinating Polyneuropathy started in Mar 2024; NCT06290141 Phase 3 started in May 2024. NCT04658472 is a Phase 2 study Chronic Inflammatory Demyelinating Polyneuropathy, recruiting as of Oct 2022 update. NCT04269551 is A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease; not yet recruiting when posted on Feb 18 2020. Bioverativ acquired by Sanof in 2018. Bioverativ acquired True North Therapeutics. |
| Full address of company | Paris, France Europe France https://www.sanofi.us/en/contact-us |
BIVV020 is a follow-on monoclonal antibody to BIVV009, with the potential for less-frequent dosing. SAR445088 is a humanized version of TNT005 (Table S1), a previously described murine antibody generated after immunization of mice with the active form of human C1s [6,7]. Like sutimlimab, SAR445088 is a human IgG4 mAb specific for C1s. However, while sutimlimab binds both the active and inactive forms of C1s, SAR445088 is specific for the active form resulting in an enhanced pharmacokinetic profile. (https://www.sciencedirect.com/science/article/pii/S1521661623001286?via%3Dihub)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |