Multiple Myeloma Treatment Study Launches in China
A Shanghai and USA based biopharmaceutical company announced the dosing of the 1st patient in mainland China in its registrational study evaluating its human CD38 antibody (TJ202/MOR202) in patients with relapsed or refractory multiple myeloma (MM).
I-Mab Biopharma said in a press release published on January 3, 2020, it had initiated 2 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 (NMPA).
The first trial, NCT03860038, is a Phase 2 trial designed to evaluate the efficacy and safety of TJ202/MOR202 as the 3rd-line treatment in patients with relapsed or refractory MM.
The 2nd trial (NCT03952091) is assessing 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. Site preparations in China have proceeded well with the first patient being dosed on schedule in the Phase 2 study.
According to the Centers for Disease Control and Prevention, multiple myeloma (MM) is a cancer of the plasma cells. Plasma cells are white blood cells that make antibodies that protect us from infection.
In myeloma, the cells grow too much, crowding out normal cells in the bone marrow that make red blood cells, platelets, and other white blood cells.
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 (NDA) for TJ202/MOR202 in Greater China.
“We are pleased that the first patient has been successfully dosed in mainland China,” said Jingwu Zang, M.D., Ph.D., Founder and Honorary Chairman of I-Mab Biopharma, in this press release.
TJ202/MOR202 is an investigational fully human monoclonal antibody derived from the MorphoSys 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, 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, an additional immune mechanism involved in tumor cell killing.
Previous scientific research suggests that anti-CD38 antibodies may have therapeutic potential in other cancers and autoimmune diseases.
I-Mab is a global biotech company exclusively focused on developing biologics of a novel or highly differentiated in the therapeutic areas of immuno-oncology and autoimmune diseases.
Myeloma Treatment news published by Vax-Before-Cancer