Biocad Prolgolimab

Main articles:

• Melanoma
• Cancer (oncological diseases)
• Cancer therapy

Prolgolimab — the medicine belonging to the category of PD-1 inhibitors aimed at recovery of activity of immunity of a human body against a tumor. Unlike the registered medicines of this class, the Russian medicine is developed on the basis of other isotype of immunoglobulin - IgG1 with the Fc-fragment modified by way of genetic engineering.

2020: Receipt in sale of domestic medicine for treatment of a melanoma of skin

On July 23, 2020 it became known that the first domestic medicine intended for therapy of a melanoma — PD-1 inhibitor with the international non-proprietary name prolgolimab came to the Russian drugstores and hospitals. Medicine was approved by the Ministry of Health of the Russian Federation for therapy of one of the most aggressive types of cancer — a metastatic or inoperable melanoma — at the end of April, 2020. Prolgolimab recovers capability of the immune system of a human body to struggle with a tumor. Inhibitor is developed and is produced by biotechnology company BIOCAD.

Prolgolimab

As it was explained, planned that medicine will be available to hospitals of the federal and regional level and also to be implemented through pharmacy chains. Inclusion of medicine in the VED list (the vital and necessary medicines) is expected at the beginning of 2021 that will allow to lower load of the budget of health care.

Cancer is a big trouble which can come to any family, especially, when it is about one of neiboly artful types of a disease — a skin melanoma. In April, 2020 we registered medicine for therapy of this disease, and in July, 2020 it became available to patients. Dmitry Morozov, the CEO of biotechnology company BIOCAD told

Domestic medicine for treatment of a melanoma of skin went on sale

The company executive reminded that prolgolimab PD-1 inhibitor on the basis of monoclonal antibodies of IgG1 with additional modifications of its effector properties is. In a human body the malignant cages destroyed by immune mechanisms are daily formed before the tumor grows enough to become threat to health. The tumor cell escapes the immune answer, masking under a normal cage that brings to its growth. PD-1 inhibitors activate T-lymphocytes and allow them to recognize and destroy malignant cages, the immune system starts over again struggling with a tumor.

Before emergence of domestic inhibitor the market of therapy of a melanoma of skin in Russia was monopolized nivolumaby and pembrolizumaby. According to Headway Company in 2019 these American medicines held the third and fourth places of MNN rating on purchasing amount. The aggregate value of the signed contracts in Russian regions for the first six months 2019 on a nivolumaba was 2,375.1 million rubles and 1,854.8 million rubles on a pembrolizumaba. Medicine entry into the market and its inclusion in VED will allow to lower load of the budget.

2019

Plans of an output of medicines netakimab and prolgolimab on the European market

On November 7, 2019 the biotechnology company BIOCAD provided netakimab and prolgolimab, original medicines on the basis of monoclonal antibodies. By also Russian producer it was announced plans of data output of medicines for the European market. Read more here.

Results of clinical trials of a prolgolimab for therapy of a melanoma

On June 25, 2019 the Biocad company provided results of clinical trials of original medicine for therapy of a melanoma.

Investments of BIOCAD into the project for June, 2019 made 737.2 million rubles.

126 patients participated in a research 18 years from Russia and Belarus with a nerezektabelny or metastatic melanoma are more senior. Primary purpose directed to achievement of frequency of the general answer more than 28% at observation within a year was reached in both studied modes of dosing of a prolgolimab: 1 mg/kg of 1 times in 2 weeks and 3 mg/kg of 1 times in 3 weeks. The complete or partial answer in 1 line of therapy prolgolimab in a dosage of 1 mg/kg of 1 times in 2 weeks was observed by medicine at 48% of patients, most of them had a deep answer and long. the 12-month survival without progressing of a disease in this group of patients was 44.6%, and the general survival reached 71.8%. Also the research showed that medicine has a favorable profile of security with a low frequency of canceling of therapy because of the undesirable phenomena. The high efficiency of therapy at appointment in the minimum dosage — 1 mg of 1 times in 2 weeks became one more feature of a prolgolimab. The mode of dosing of 1 mg/kg of 1 times in 2 weeks will be recommended for clinical application based on the research MIRACULUM.

Daily in an organism even of the healthy person malignant cages which are destroyed by immune mechanisms of the person still before the tumor grows enough are formed to become threat to health. The tumor cell can escape the immune answer by masking under a normal cage that leads to growth of a tumor because of powerlessness of the immune system to resist to malignant processes. PD-1 inhibitors activate T-lymphocytes and allow them to recognize and destroy malignant cages thanks to what the immune system starts over again struggling with a tumor.

The research MIRACULUM was conducted for the purpose of medicine registration prolgolimab in the territory of the Russian Federation according to the indication "a nerezektabelny or metastatic melanoma" which receiving is expected in the fall of 2019. Growth of number of patients with the diagnosis a melanoma for the last 10 years increased by 40 percent, in 2018 more than 11 thousand cases were registered.

The immunotherapy of oncological diseases is one of the most perspective directions of world medicine. Over 1500 researches of new inhibitors of control points of immunity are annually conducted. Growth of global market is measured by two-digit numbers, at the end of 2018 it made 14 billion dollars. The Russian research and development in the field of an immunotherapy of cancer is capable to contribute significantly to world science and practice.