I-Mab moves in multiple myeloma
SHANGHAI—I-Mab Biopharma Co., Ltd. has announced that the company recently dosed the first patient in mainland China in its registrational study evaluating the human CD38 antibody (TJ202/MOR202) in patients with relapsed or refractory multiple myeloma (MM).
TJ202/MOR202 is an investigational fully human monoclonal antibody originally developed from MorphoSys AG’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 mechanism of action, TJ202/MOR202 recruits cells of the body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. The antibody does not involve complement dependent cytotoxicity. Research suggests that anti-CD38 antibodies may also have therapeutic potential in other cancers and autoimmune diseases.
I-Mab initiated two registrational trials with TJ202/MOR202 in relapsed or refractory MM in Taiwan in early 2019, and expanded these trials into mainland China in late 2019 after receiving IND clearance from the National Medical Products Administration. The first trial, a Phase 2 trial, is designed to evaluate the efficacy and safety of TJ202/MOR202 as a third-line treatment in patients with relapsed or refractory MM. The second trial is meant to assess 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.
“The initiation of enrollment in China of TJ202/MOR202 is an important milestone,” said Jingwu Zang, M.D., Ph.D., founder and honorary chairman of I-Mab Biopharma. “We look forward to accelerating TJ202/MOR202 clinical program significantly towards registration, which will benefit the patients with multiple myeloma in China.”
I-Mab notes that site preparations in China have proceeded well; the first patient in the Phase 2 study was dosed on schedule. Under I-Mab’s fast-to-market development strategy, both studies have been designed as pivotal trials — which, if successful, could pave the way for new drug applications for TJ202/MOR202 in greater China.
TJ202/MOR202 has reportedly shown promise both in preclinical animal studies and early human clinical trials. I-Mab licensed the product from MorphoSys and owns the exclusive rights for development and commercialization in mainland China, Hong Kong, Macao and Taiwan. I-Mab is developing TJ202/MOR202 in multiple myeloma and in certain autoimmune diseases, including systemic lupus erythematosus.