Russian drugmaker R-Pharm said it has completed pilot preclinical studies of two innovative bispecific antibodies developed to treat malignant tumors. The molecules were created from scratch at the company’s Early Biological Drug Development Laboratory in Pushchino and are original products with no existing market equivalents, the manufacturer’s press service said. If subsequent stages are successful, the company plans to initiate clinical trials.
Each of the antibodies can simultaneously bind to two molecular targets on the surface of tumor cells, the developers explained. This dual mechanism of action improves targeting specificity, reduces the risk of systemic adverse events, and increases treatment efficacy.
The next stage involves developing pilot-scale technology for commercial manufacturing and conducting expanded animal studies, the company said. The structural characteristics of the molecules require new approaches to scaling up production, formulating the final dosage form, and confirming product stability.
“We are focusing on autoimmune and oncological diseases — these are the areas where the need for new solutions is greatest today,” said Maxim Vlasyuk, head of pharmaceutical development at R-Pharm. “For the Russian pharmaceutical industry, developments of this scale represent a true breakthrough: few companies in the country are capable of undertaking such projects in biopharma.”
Last year, R-Pharm said it planned to expand its portfolio of proprietary oncology drugs. Currently the portfolio consists primarily of generic chemical and biological products, including biosimilars of monoclonal antibodies whose analogues have not yet appeared on the Russian market.
