Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 406 |
| INN | Seniprutug |
| Status | Approved |
| Drug code(s) | BCD-180 |
| Brand name | Tribuvia |
| 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) | TCR Vbeta9 |
| Indications of clinical studies | Ankylosing Spondylitis, Axial Spondyloarthritis, Phase 1 in healthy volunteers |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | January 22, 2021 |
| Start of Phase 2 | April 19, 2022 |
| Start of Phase 3 | December 25, 2023 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2024 |
| Date of first US approval | |
| INN, US product name | Seniprutug |
| US or EU approved indications | None |
| Company | Biocad |
| Licensee/Partner | None |
| Comments about company or candidate | May 1, 2024 press release: The Ministry of Health of the Russian Federation has registered a first-in-class original drug for the treatment of patients with radiological axial spondyloarthritis (Bechterew's disease), developed by the biotechnological company BIOCAD together with scientists from the Russian National Research Medical University named after. N.I. Pirogova. The drug received the trade name Tribuvia®, the international non-proprietary name of the drug is seniprutug. https://biocad.ru/news/v-rossii-zaregistrirovali-pervyj-v-mire-preparat-sposobnyj-ostanovit-razvitie-bolezni-behtereva NCT06333210 Phase 3 in Axial Spondyloarthritis started in Dec 2023. NCT05445076 Phase 2 started in April 2022. |
| Full address of company | 198515, Saint Petersburg, Intracity Municipality the Settlement of Strelna, ul. Svyazi, d. 38, str. 1, pomeshch. 89 Europe Russia https://biocadglobal.com/contacts |
anti-TRBV9 monoclonal antibody. T-cell receptors with variable TRBV9 β-chain regions have been recently associated with spondyloarthritis including its subtype, ankylosing spondylitis. The aim of this work was to engineer a chimeric monoclonal antibody targeting the variable region of the T-cell receptor β-chain encoded by the TRBV9 gene segment and assess its specificity and cytotoxicity. Using flow cytometry and next generation sequencing, we demonstrate that the engineered chimeric antibody is highly specific and exhibits cytotoxic activity against its target. Approaches based on the use of therapeutic chimeric antibodies against pathogenic T-clones may hold great promise for the therapy of autoimmune disorders in general and AS in particular. (https://vestnik.rsmu.press/archive/2018/5/12/abstract?lang=en)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |