Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 31 |
| INN | Prolgolimab |
| Status | Approved |
| Drug code(s) | BCD-100 |
| Brand name | Forteca |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | Vlambda-Ckappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | PD-1 |
| Indications of clinical studies | Non-small cell lung cancer, Melanoma, Solid tumors |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Approved Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2016 |
| Start of Phase 2 | |
| Start of Phase 3 | August 31, 2017 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2020 |
| Date of first US approval | |
| INN, US product name | Prolgolimab |
| US or EU approved indications | None |
| Company | Biocad |
| Licensee/Partner | None |
| Comments about company or candidate | April 27, 2020: The first Russian original PD-1 inhibitor Forteca® (INN: prolgolimab) was granted approval for market authorization by the Russian Ministry of Health for the treatment of one of the most aggressive types of cancer -- unresectable or metastatic melanoma. The approval is based on the positive clinical results from a multicenter open-label parallel-arm phase II study MIRACULUM (NCT03269565) in patients with advanced melanoma. EudraCT Number 2018-004791-36 (BCD-100-3/DOMAJOR) started in Hungary and Slovakia in Sep 2019. NCT03912389 (DOMAJOR; NSCLC) and NCT03912415 (cervical cancer) Phase 3 studies not yet recruiting; last updated in May 2019. Conclusions from Phase 2 NCT03269565 study in melanoma: Both dosing regimens of BCD-100 (1 mg/kg Q2W and 3 mg/kg Q3W) have durable antitumor activity and a manageable safety profile in patients with advanced melanoma. (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.9549?af=R) Phase 2/3 study started Aug 31, 2017 still recruiting as of Aug 1, 2018. Phase 2/3 in NSCLC recruiting as of Oct 2017. NCT03050047 Phase 1. Innovative molecule according to Biocad |
| 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. Immunoglobulin G1_V-lambda-C-kappa. BCD-100 is an IgG1 anti-PD-1 monoclonal antibody with Fc silencing “LALA” mutation. (https://abstracts.asco.org/239/AbstView_239_267653.html). Sequence found in patent (https://patents.google.com/patent/RU2656181C1/en)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |