Biocad is a Russian biotechnology company that makes biosimilars of rituximab, bevacizumab and trastuzumab and developed prolgolimab, the first anti-PD-1 antibody approved in Russia, now tested with its anti-CTLA-4 partner nurulimab in melanoma.
Biocad, based in St Petersburg, is Russia's largest biotechnology company by its own account, with biosimilars of rituximab, bevacizumab and trastuzumab that supply much of the Russian market and an in-house immuno-oncology pipeline. Its anti-PD-1 antibody prolgolimab (BCD-100, brand name Forteca) received Russian approval for melanoma in 2020 and is in phase 3 trials as a fixed combination with the anti-CTLA-4 antibody nurulimab (BCD-217) in unresectable and resectable melanoma. Sponsor and trial facts are from the ClinicalTrials.gov registry; company facts are from the official website.
BCD-100 is an experimental investigational agent whose form is not stated in the registry from Biocad in phase 3 trials for melanoma, with its target not yet stated publicly.
BCD-217 is an experimental investigational agent whose form is not stated in the registry from Biocad in phase 3 trials for melanoma, aimed at PD-1 and CTLA-4.
A domestically developed checkpoint antibody has now produced a positive phase 3 overall-survival result in lung cancer, which is the strongest evidence yet that Russian oncology can supply its own immunotherapy rather than import it. The trial ran in Russia with sites in China, Hungary and Slovakia and has not been reviewed by the European Medicines Agency or the United States Food and Drug Administration.
This is the evidence on which Russia licensed a PD-1 antibody of its own making, which matters because it is the reason immunotherapy remained available in Russian melanoma clinics on domestic supply. It is a single-country randomised phase 2 with no comparator against an established PD-1 antibody, so it does not establish equivalence with nivolumab or pembrolizumab.
Shares N. N. Petrov National Medical Research Centre of Oncology, N. N. Blokhin National Medical Research Center of Oncology.
Shares N. N. Petrov National Medical Research Centre of Oncology, N. N. Blokhin National Medical Research Center of Oncology.
Shares N. N. Petrov National Medical Research Centre of Oncology, N. N. Blokhin National Medical Research Center of Oncology.
Shares DOMAJOR: prolgolimab with chemotherapy first line in advanced non-squamous lung cancer, MIRACULUM: prolgolimab, the first Russian-developed anti-PD-1 antibody, in advanced melanoma.