Biocad is developing a cure for melanoma
Preclinical studies will begin in 2015
the first innovative Russian drug for skin melanoma
BIOCAD has developed a revolutionary drug for the treatment of skin melanoma BCD-100. According to experts, the new drug will significantly increase the life expectancy of patients with metastatic melanoma. BCD-100 is a drug based on a monoclonal antibody to the PD–1 antigen. This is a new generation drug that stimulates the destruction of tumor cells by the patient's own immune system without damaging healthy tissues. Preclinical trials of the innovative drug are scheduled for the first half of 2015.
Melanoma is the most aggressive and dangerous skin cancer. According to the Federal State Budgetary Institution "Russian Oncological Research Center named after N. N. Blokhin" of the Russian Academy of Medical Sciences, melanoma accounts for only 4% of skin malignancies, but up to 80% of deaths. At the local-regional stage (III) of the disease, the survival rate of patients is only 45%, and at metastatic (IV stage) does not exceed 10%. After the diagnosis of "stage IV melanoma", patients do not live long, on average 6-8 months. In 2013, the proportion of Russian patients with advanced melanoma (stage III-IV) was almost 23.8%, while in the European Union, the USA and Australia it did not exceed 13%. Such figures are given by the Federal State Budgetary Institution "Moscow Research Oncological Institute named after P. A. Herzen".
Doctors see the main reason for failures in the treatment of inoperable metastatic melanoma in the low effectiveness of systemic therapy of disseminated forms of the disease. The tumor is resistant to the main groups of chemotherapeutic drugs. The clinical effect on the growth of metastases is achieved only in 10-20% of cases. According to experts, the use of monoclonal antibodies to the PD-1 antigen will lead to a stop in tumor development in 30-40% of patients. This will be a real breakthrough in the treatment of metastatic melanoma.
"For the first time in 30 years, a fundamentally new type of medicines has appeared, which increases the life expectancy of patients in the last stages of melanoma. And thanks to the achievements of domestic pharmaceuticals, Russian patients will be among the first to get access to it. Already in the first half of 2015, BIOCAD will begin preclinical trials of an innovative drug BCD-100 based on a monoclonal antibody to the PD-1 antigen. The drug has been developed by the company since 2013," says Roman Ivanov, Vice President for Development and Research at BIOCAD. – Cells of many malignant neoplasms, interacting with the PD-1 protein, successfully hide from the attack of the human immune system. Blockade of the PD-1 antigen with a monoclonal antibody restores the body's ability to recognize and destroy cancer cells."
Other major pharmaceutical corporations, such as AstraZeneca, BMS, and Roche, are also conducting studies of monoclonal antibodies to the PD-1 target. Even there is already the first registered drug of Megsk company from September 5, 2014 in the USA. However, the Russian drug BCD-100 has a number of advantages. First of all, BIOCAD's medicine lacks amino acid sequences of animal origin, which minimizes its immunogenicity and guarantees high safety for humans. Secondly, the drug molecules have an increased affinity for the FcRn receptor. This provides a longer half-life of the drug from the body and reduces the frequency of administration of the drug to the patient.
Currently, BIOCAD specialists have obtained a number of candidates that effectively prevent the interaction of PD-1 with its ligand. A thorough analysis of all applicants is carried out. As a result, the final candidate for preclinical research will be selected. Already at the end of 2015, preparations will begin for the next stage – conducting clinical trials.
At the same time, the company is developing a number of other drugs based on monoclonal antibodies to such targets on immunocompetent cells as TIM-3, LAG-3, CTLA-4, 4-1BB. The new drugs will provide a multiple increase in the effectiveness of the antibody to the PD-1 antigen, provided they are used together.
Immunotherapy based on the use of a combination of monoclonal antibody drugs is the therapy of the future. Thanks to a drug based on a monoclonal antibody to the PD-1 protein, a revolution is already taking place in the treatment of melanoma. Next in line are other malignant tumors – lung cancer, kidney cancer, colorectal cancer and others. Modern Russian pharmaceuticals is at the forefront of the latest scientific achievements and is ready to offer them not only to domestic, but also to world medicine.
Portal "Eternal youth" http://vechnayamolodost.ru03.10.2014