In 2015, pre-clinical trial of the first Russian innovative product for treating skin melanoma will begin

In 2015, pre-clinical trial of the first Russian innovative product for treating skin melanoma will begin

BIOCAD has developed a revolutionary product for treating skin melanoma (currently referred to as BCD-100). According to the experts, the new drug will significantly increase the life expectancy of patients with metastatic melanoma. BCD-100 is a product based on monoclonal antibodies to PD-1 antigen. This is a new generation product, which stimulates the elimination of tumor cells with the use of patient’s own immune system, without damaging the healthy cells. The pre-clinical trial is scheduled to begin in the first half of 2015. Melanoma is one of the most aggressive and dangerous types of skin cancers. Data from the Blokhin Oncology R&D Institute in Moscow demonstrates that melanoma makes up only 4% of all skin cancer cases, yet up to 80% of cases result in death. At stage 3 progression (local skin condition) only 45% of patients survive. At stage 4 (the metastatic stage), the survival rate is no more than 10%. After the diagnosis of the 4th stage is given, patients on average survive 6 to 8 months. In 2013, the portion of Russian patients diagnosed with melanoma of 3rd or 4th stage amounted to 23.8%, when in the EU, US and Australia the figure was below 13%, according to the data from the Hertzten Oncology R&D Institute in Moscow. Doctors see the main cause of failure in the treatment of inoperable metastatic melanoma in a low efficiency of systemic therapy of disseminated forms of the disease. The tumor is resistant to the main groups of chemotherapy drugs. Clinical effect of arresting the growth of metastases can only be achieved in 10 to 20 per cent of cases. Experts predict that the use of monoclonal antibodies to PD-1 antigen will stop the growth of tumors in 30 to 40 per cent of cases. It will be a real breakthrough in the treatment of metastatic melanoma. “For the first time in the last thirty years a completely different type of drug is being developed, which increases the life expectancy of the patients at last stages of progression of melanoma. And thanks to the achievements of domestic pharmaceutical industry, Russian patients will be among the first to have access to this product. As early as the first half of 2015, BIOCAD will commence undertaking pre-clinical studies on the innovative product BCD-100 on the basis of monoclonal antibodies to PD-1 antigen. We’ve been developing the product since 2013,” said Roman Ivanov, Vice President for Research & Development at BIOCAD. “Cells of many malignancies interact with PD-1 protein, and hence, successfully hide from the human immune system. PD-1 antigen blockade by monoclonal antibodies returns the body's ability to identify and destroy cancer cells”. Other major pharmaceutical companies carry out studies of monoclonal antibodies to PD-1 antigen. Already there is a registered product by Merck as of 5th September 2014 in U.S. However, the Russian product BCD-100 has a few advantages. First, the BIOCAD medicine does not include amino acid sequences of animal origin, thus, its immunogenicity is minimized and high safety for humans is guaranteed. Second, the drug molecules have a higher affinity for the FcRn receptor. This provides a greater half-life and reduces the drug’s frequency of administration. Currently, BIOCAD’s professionals have received a number of candidates, which effectively prevent the interaction of PD-1 with its ligand. Following thorough analyses, a candidate will be selected. Clinical trials will start already by the end of 2015. At the same time BIOCAD develops a number of products based on monoclonal antibodies to targets on immunocompetent cells such as TIM-3, LAG-3, CTLA-4, 4-1BB. New products will provide the opportunity to increase the effectiveness of antibodies to antigen PD-1 significantly. Immunotherapy based on a combination of monoclonal antibodies is the therapy of the future. Breakthrough is already happening in melanoma therapy, thanks to the drug based on monoclonal antibody to PD-1. Next in line to be targeted are such malignancies as lung cancer, renal carcinoma, colorectal cancer and others. Modern Russian pharmaceutical industry is at the forefront of the latest scientific developments and is ready to offer latest products not only locally, but also globally.