MorphoSys and I-Mab Biopharma have announced plans to expand the ongoing Phase II and III multiple myeloma (MM) clinical trials to mainland China following clearances from the National Medical Products Administration (NMPA).
The trials are being conducted in Taiwan to assess MorphoSys’s human monoclonal antibody, MOR202/TJ202, which acts against CD38 present on the surface of MM cells.
I-Mab holds the exclusive licence to develop and commercialise MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.
The company launched the Phase II trial in Taiwan in March with the aim of investigating the safety and efficacy of the drug candidate as third-line therapy in relapsed or refractory (r/r) MM patients.
Commenced in April, the Phase III trial is evaluating the safety and efficacy of MOR202/TJ202 in combination with lenalidomide (LEN) and dexamethasone (DEX) compared to LEN plus DEX.
The Phase III study will enrol patients with relapsed or refractory MM who had at least one previous line of treatment.
I-Mab will expand these studies to mainland China as part of the fast-to-market development strategy.
I-Mab Biopharma founder and chairman Dr Jingwu Zang said: “Receiving two IND clearances for MOR202/TJ202 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 MOR202/TJ202 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.”
I-Mab signed the MOR202/TJ202 licensing agreement with MorphoSys in November 2017.
MorphoSys chief development officer Dr Malte Peters said: “There is a high need for alternative treatment options for patients with r/r multiple myeloma in the Chinese region and we look forward to the further development of MOR202/TJ202 by our partner I-Mab in this indication.”