Chinese clinical-stage biopharmaceutical company I-Mab Biopharma and German biotech company MorphoSys have begun the first dosed Phase III clinical study to assess investigational human CD38 antibody TJ202/MOR202 in combination with lenalidomide in patients suffering from relapsed or refractory multiple myeloma.
MorphoSys has developed the investigational human CD38 antibody TJ202/MOR202, which is derived from MorphoSys’s HuCAL antibody technology.
I-Mab has the exclusive rights to develop and commercialise TJ202/MOR202 in China, Taiwan, Hong Kong, and Macau.
I-Mab head of R&D Dr Joan Shen said: “The initiation of our first Phase III trial represents another important milestone in advancing TJ202/MOR202 towards registration with the hope of providing more therapeutic options for MM patients globally.
“With planned enrollment of 291 patients, this will be a broad trial of this second most common blood cancer worldwide.
“In parallel with our pivotal Phase II trial of TJ202/MOR202 in combination with dexamethasone, the Phase III study will further assess the efficacy of TJ202/MOR202 as a potential second-line treatment in MM.”
If successful, the study is expected to result in a biologics licence application (BLA) in Greater China under I-Mab’s fast-to-market development strategy.
Both companies will conduct the randomised, multi-centre study in mainland China and Taiwan to evaluate the combination of TJ202/MOR202 plus lenalidomide (LEN) and dexamethasone (DEX) in comparison to the LEN and DEX combination in patients with relapsed or refractory MM who received at least one prior line of treatment.
The primary endpoint is to evaluate progression-free survival (PFS), comparing the effectiveness of TJ202/MOR202 plus LEN/DEX versus LEN/DEX.
With the dosing of the first patient, MorphoSys will receive a milestone payment of $3m.
I-Mab is leading the clinical development of TJ202/MOR202 in Greater China, including mainland China, Hong Kong, Macao, and Taiwan with MorphoSys’s support through a licensing agreement in November 2017.
I-Mab has also filed an investigational new drug (IND) application with China’s National Medical Products Administration in August 2018.
Both companies had announced the first patient dosing of TJ202/MOR202 in a Phase II clinical study in Taiwan on 20 March 2019.
I-Mab focuses on the development of innovative biologics in immuno-oncology and autoimmune diseases.