BCD-217 is a combination of two monoclonal antibodies, an original investigational product for human use being developed for the treatment of melanoma.
A monoclonal antibody is a protein created by scientists in a laboratory, similar to the natural antibodies of the immune system, designed to bind to a specific target in the human body1.
BCD-217 contains two monoclonal antibodies, i.e. against the CTLA-4 receptor (nurulimab, BCD-145) and against the PD-1 receptor (prolgolimab, BCD-100, Forteсa®).
The efficacy and safety of BCD-217 for the treatment of melanoma (malignant skin tumor) are being studied.
BCD-217 specifically binds to the PD-1 (programmed cell death protein) and CTLA-4 (cytotoxic T-lymphocyte glycoprotein 4) proteins, which are located on the surface of various immune cells. They are involved in the regulation of the immune system by its partial suppression. Anti-PD-1 and anti-CTLA-4 antibodies can prevent this suppression and the immune system can recognize and destroy tumor cells2,3.
Non-clinical studies in animals have confirmed the safety and anticancer activity of BCD-217. One of the components of BCD-217, Forteсa® (BCD-100, international nonproprietary name: prolgolimab), was authorized by the Ministry of Health of the Russian Federation on April 16, 2020 and is intended for the treatment of patients with unresectable, metastatic melanoma4.
In the clinical study, the subjects will receive BCD-217 with further switching to Forteсa® or Forteсa® only depending on which group they are randomized to. The physician-investigator closely monitors the patient’s condition throughout their participation in the study and will take all necessary actions to manage adverse events if they occur.
- Weiner LM, Surana R., Wang S. Monoclonal antibodies: versatile platforms for cancer immunotherapy. Nature Reviews Immunology. 2010;10(5):317–27.
- Rowshanravan B., Halliday N., Sansom DM. CTLA-4: a moving target in immunotherapy. Blood. 2018 Jan 4;131(1):58-67. doi: 10.1182/blood-2017-06-741033. Epub 2017 Nov 8. PMID: 29118008; PMCID: PMC6317697.
- Elezov D. S., Kudryavtsev I. V. PD-1 receptor on immune cells, its expression and potential role in cancer therapy. Cell Ther Transplant 2019; 8(2): 8–16.
- Tyulyandin S. A., Fedyanin M. Yu., Semiglazova T. Yu., Moiseenko V. M., Odintsova S. V., Alekseev B. Ya. et al. BCD-100 – first Russian PD-1 inhibitor. Journal of Modern Oncology. 2017;19(3):5–12.
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