I-Mab Biopharma has commenced a registrational study in mainland China to assess the efficacy of its human CD38 antibody (TJ202/MOR202) in patients with relapsed or refractory multiple myeloma (MM).
The study began by enrolling and dosing the first patient of the study.
I-Mab Biopharma founder and honorary chairman Jingwu Zang said: “We are pleased that the first patient has been successfully dosed in mainland China.
“The initiation of enrolment in China of TJ202/MOR202 is an important milestone. We look forward to accelerating TJ202/MOR202 clinical programme significantly towards registration, which will benefit the patients with multiple myeloma in China.”
TJ202/MOR202 is an investigational fully human monoclonal antibody developed to inhibit CD38 on the surface of multiple myeloma cells.
The antibody utilises the cells of the body’s immune system to kill the tumour through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Last year, I-Mab began its first registrational trials with TJ202/MOR202 in relapsed or refractory MM at Taiwan.
Subsequently, the company expanded the trials into mainland China following the approval of the National Medical Products Administration (NMPA).
The first trial (NCT03860038), a Phase II trial, was designed to assess the effectiveness of TJ202/MOR202 as a third-line treatment in patients with relapsed or refractory MM.
In the second trial (NCT03952091), the company seeks to evaluate the efficacy and safety of the combination of TJ202/MOR202 with lenalidomide (LEN) and dexamethasone (DEX) against the combination of LEN and DEX in patients with relapsed or refractory MM who have already received at least one prior line of treatment.
Established in 2016, I-Mab is a private biopharmaceutical company with offices in China and the US.
Under an agreement with MorphoSys, the company owns exclusive rights for the development and commercialisation of TJ202/MOR202 in mainland China, Hong Kong, Macao and Taiwan.