On October 14, 2019 I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases and German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;Nasdaq: MOR), reported that I-Mab has received Investigational New Drug (IND) clearances from the National Medical Products Administration (NMPA) of China to expand the ongoing phase II and III clinical trials of TJ202/MOR202, MorphoSys’s human monoclonal anti-CD38 antibody for the treatment of multiple myeloma (MM), also to mainland China (Press release, MorphoSys, OCT 14, 2019, View Source [SID1234540982]). I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in China, Taiwan, Hong Kong and Macao.
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I-Mab is currently conducting two clinical trials with TJ202/MOR202 in Taiwan. The phase II study, which was initiated in March 2019, is designed to evaluate the efficacy and safety of TJ202/MOR202 as third-line treatment in patients with relapsed or refractory MM. The phase III study, initiated in April 2019, assesses the efficacy and safety of the combination of TJ202/MOR202 plus lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory MM who received at least one prior line of treatment. Under the fast-to-market development strategy, I-Mab will now be expanding these trials into mainland China.
"Receiving two IND clearances for TJ202/MOR202 from the China NMPA marks an important milestone for us and demonstrates I-Mab’s capability and commitment to the advancement of immunological technology for the market. We will move forward with the clinical development of TJ202/MOR202 in China to bring it to the market as efficiently as possible. I-Mab will continue to expand our portfolio in innovative therapeutics to benefit patients in need," commented Dr. Jingwu Zang, MD., PhD., Founder and Chairman of I-Mab Biopharma.
"We are very pleased that our partner I-Mab now also received the IND clearances for TJ202/MOR202 for China, allowing the expansion of the clinical development of TJ202/MOR202 in multiple myeloma to mainland China," commented Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "There is a high need for alternative treatment options for patients with multiple myeloma in the Chinese region and we look forward to the further development of TJ202/MOR202 by our partner I-Mab in this indication."
About TJ202/MOR202
TJ202/MOR202 is an investigational human monoclonal antibody derived from MorphoSys’s HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which 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 body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific researche suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.