First Russian original PD-1 inhibitor got approved

Saint Petersburg, April 22, 2020: On April 20, the Russian Ministry of Health approved the first Russian original PD-1 inhibitor  Forteca® (INN: prolgolimab) for the treatment of one of the most aggressive types of cancer—metastatic or inoperable melanoma. Prolgolimab acts as PD-1 inhibitor and helps to restore the ability of the human immune system to fight a tumor. Its registration was an important step in immuno-oncology development and treatment of patients with malignant neoplasms.

Melanoma is a malignant tumor that develops from melanocytes –  pigment cells producing melanin. According to the WHO, skin melanoma accounts for about 3-4% of all oncological diseases in adults, and by 2025 the number of cases of skin melanoma in the world will increase by 25%. In Russia, according to the “State of Oncological Care for the Population of Russia in 2018” guide, in 2018, skin melanoma was detected already in advanced stages in 19% of the initial visit to an oncologist cases, which leads to an unfavorable prognosis and low patient survival.

Prolgolimab fights this dangerous tumor being the first Russian PD-1 inhibitor. It is a monoclonal antibody of the IgG1 isotype with an Fc fragment modified by genetic engineering. The mechanism of action of PD-1 inhibitors is aimed at restoring the ability of T-lymphocytes to recognize and destroy malignant cells, as a result of which the human immune system again begins to fight the tumor.

Cancer immunotherapy is one of the most promising areas of world medicine. Over 1,500 studies of new inhibitors of immunity control points are conducted annually. The growth of the global market for immunotherapeutic drugs in the end of 2018 amounted to $14 billion.

“We are pleased that BIOCAD can offer a new option for the treatment of patients with inoperable or metastatic melanoma. Progolimab is a unique drug in terms of its structure: it is the first PD-1 inhibitor based on IgG1 monoclonal antibodies with additional modifications of its effector properties. Registration of the first original PD-1 inhibitor in Russia was an important stage in the development of immuno-oncology and treatment of patients with malignant neoplasms,” said Dmitry Morozov, BIOCAD CEO.

International clinical trials of the new drug is already planned and now going through registration procedures in several countries, including China, Austria, Germany, Check Republic, Turkey and others. They are supposed to be launched already this year.

Corporate Comm India (CCI Newswire)