Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 407 |
| INN | Nurulimab |
| Status | Approved |
| Drug code(s) | BCD-217 in combo with prolgolimab, BCD-145 |
| Brand name | Nurdati® |
| mAb sequence source | mAb human |
| 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) | CTLA-4 |
| Indications of clinical studies | Melanoma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | October 02, 2017 |
| Start of Phase 2 | July 01, 2019 |
| Start of Phase 3 | August 02, 2022 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2023 |
| Date of first US approval | |
| INN, US product name | Nurulimab |
| US or EU approved indications | None |
| Company | Biocad |
| Licensee/Partner | None |
| Comments about company or candidate | Dec19, 2023 press release: The Ministry of Health of the Russian Federation has registered an original drug for the treatment of unresectable or metastatic melanoma. The drug was developed by the biotechnology company BIOCAD and is a fixed combination of two monoclonal antibodies - nurulimab and prolgolimab. The drug received the trade name Nurdati®. Granted conditional registration following procedure* provided for by decision No. 78 of the EEC Council. https://biocad.ru/news/minzdrav-rossii-zaregistriroval-novyj-rossijskij-preparat-dlya-terapii-melanomy NCT05751928 Phase 3 started in Mar 2023. NCT05732805 Phase 3 started in Aug 2022. NCT03913923 Phase 2 of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma (OBERTON) NCT03472027 Phase 1 study completed in 2019. |
| 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 |
Immune checkpoint target
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |