I-mab biopharma announces the approval of new immunotherapy for clinical trials of multiple myeloma in China

I-mab biopharma, a clinical biopharma company headquartered in China and the United States, is dedicated to the discovery and development of new or highly differentiated biological agents in immunooncology and autoimmune diseases, and the German biopharma company morphasys Ag today announced that i-mab has obtained the research drug (ind) license from China National Drug Administration (nmpa) Phase II and phase III clinical trials of human monoclonal anti-CD38 antibody tj202 / mor202 for the treatment of multiple myeloma (mm) will be conducted in mainland China I-mab has the exclusive right to develop and commercialize tj202 / mor202 in China, Taiwan, Hong Kong and Macao I-mab is currently conducting two clinical trials on tj202 / mor202 in Taiwan The second phase of the study, which was launched in March 2019, aims to assess the efficacy and safety of tj202 / mor202 as a third-line treatment in patients with recurrent or refractory MM The phase III study, which was launched in April 2019, evaluated the efficacy and safety of the combination of tj202 / mor202 plus lenalidomide (len) and dexamethasone (DEX) with len and Dex in patients with recurrent or refractory MM According to the rapid launch development strategy, i-mab will now extend these trials to the mainland of China Tj202 / mor202 is a kind of research human monoclonal antibody developed and produced by HuCAL antibody technology of MorphoSys This antibody is directed against CD38 on the surface of multiple myeloma cells, and has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells According to its suggested mode of action, the antibody recruits cells of the human immune system to kill tumors through antibody dependent cytotoxicity (ADCC) and antibody dependent phagocytosis (ADCP) The antibody does not involve complement dependent cytotoxicity or CDC, which is another immune mechanism involved in tumor cell killing Scientific research shows that anti-CD38 antibody may also have therapeutic potential in other cancers and autoimmune diseases According to the license agreement signed by MorphoSys and i-mab in November 2017, i-mab has the exclusive right to develop and commercialize tj202 / mor202 in mainland China, Taiwan, Hong Kong and Macao (Bio Valley / bio Com) original source: Tianjing biology official website