Revolutionary Russian anti-cancer anti-PD1 medicine candidate has successfully ended pre-clinical animal trials, i.e. on primates. So far the product has demonstrated higher efficacy than the only two approved medicines acting against the same therapeutic target – pembrolizumab from Merck and nivolumab from BMS.
BIOCAD is now preparing for the first international multi-center clinical trials. Patients in Russia will be among the first to get access to the new generation therapy. The medicine is expected to be available to patients as early as in 2018 or 2019.
The new drug activates human body’s own defenses to fight cancer. The product, being a monoclonal antibody, blocks interactions between PD-1 and PD-L1 proteins that mask malignant cells as healthy ones, thus confusing the patient’s immune system. Upon neutralizing of PD-1, human body starts recognizing tumor cells as foreign, and starts fighting them.
“Development of immuno-oncology therapies is an innovative approach to treating cancer”, says Roman Ivanov, M.D., BIOCAD’s Vice-President of Research and Development. The check-point inhibitors, such as our innovative drug candidate, have the potential to revolutionize treatment strategy in oncology, as they are able to stop the entire progression of malignant growth, destroying not only the primary tumor, but metastases as well, including the remote ones.” At the same time, Dr. Ivanov added, healthy tissues are not damaged, unlike during toxic chemotherapy.
There are only two approved anti-PD-1 drug products based on monoclonal antibodies, both registered recently. One is by MSD, the other one is manufactured by Bristol-Myers Squibb. None of the products is approved in Russia, and is therefore unavailable to patients here. BIOCAD candidate is an original internal Company development and aims to compete alternate therapies worldwide.
Pre-clinical trials of BIOCAD’s new drug have demonstrated higher level of specific biological activity than the product by Bristol-Myers Squibb. Safety profiles of the two drug products are very similar, as they only contain a human monoclonal antibody in their composition. The MSD’s drug product has a mouse protein that may cause immune response, and therefore to lower the antibody’s efficacy and safety.
Researchers predict that biological drug products based on monoclonal antibodies can stop the development of cancer in 30 to 40% of patients. This will mean a true revolution in the available therapies, including the treatment of non-operable metastatic melanoma.
Monoclonal antibodies to PD-1 have strong therapeutic potential not only against melanoma, but also in treating non-small cell lung cancer and renal cell carcinoma. BIOCAD intends to conduct clinical trials for all three indications.