I-Mab to expand ongoing phase II and III clinical trials of TJ202/MOR202 into China under fast-to-market development strategy.
M2 PHARMA-October 14, 2019-I-Mab to expand ongoing phase II and III clinical trials of TJ202/MOR202 into China under fast-to-market development strategy
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German biopharma company MorphoSys AG (FSE:MOR) (Nasdaq:MOR) stated that I-Mab Biopharma 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 for the treatment of multiple myeloma (MM) into China.
The 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. 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).
I-Mab, which owns the exclusive rights for development and commercialisation of TJ202/MOR202 in China, Taiwan, Hong Kong and Macao, is currently conducting two clinical trials with TJ202/MOR202 in Taiwan.
Launched in March 2019, I-Mab's phase II study is designed to evaluate the efficacy and safety of TJ202/MOR202 as third-line treatment in patients with relapsed or refractory MM.
Initiated in April 2019, I-Mab's phase III study 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.
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|Date:||Oct 14, 2019|
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