MorphoSys AG and I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, announced today that the first patient has been dosed in a phase 3 randomized and multi-center clinical study in Taiwan to evaluate MorphoSys’s investigational human CD38 antibody MOR202/TJ202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma. I-Mab has exclusive rights for development and commercialization of MOR202/TJ202 in China, Taiwan, Hong Kong and Macao.
“The initiation of our first phase 3 trial represents another important milestone in advancing MOR202/TJ202 towards registration with the hope of providing more therapeutic options for multiple myeloma patients globally. With planned enrollment of 291 patients, this will be a broad trial of this second most common blood cancer worldwide,” said Dr. Joan Shen, M.D., Head of R&D at I-Mab. “In parallel with our pivotal phase 2 trial of MOR202/TJ202 in combination with dexamethasone, the phase 3 study will further assess the efficacy of MOR202/TJ202 as a potential second line treatment in multiple myeloma.”
Under I-Mab’s fast-to-market development strategy, the phase 3 study, if successful, could lead to a biologics license application (BLA) in Greater China. The randomized, open-label, parallel-controlled, multicenter study will be conducted in mainland China and Taiwan to evaluate the efficacy and safety of the combination of MOR202/TJ202 plus lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory multiple myeloma who received at least one prior line of treatment. The primary endpoint is to evaluate the progression-free survival (PFS) comparing the efficacy of MOR202/TJ202 plus LEN/DEX versus LEN/DEX.
The dosing of the first patient triggers a milestone payment of USD 3 million to MorphoSys.
“We are delighted that our partner I-Mab has started a phase 3 trial of MOR202/TJ202 in combination with lenalidomide in Asia in addition to the ongoing phase 2 trial of MOR202 in combination with dexamethasone. We see a high medical need for the treatment of patients with multiple myeloma in the Chinese region and look forward to supporting I-Mab in developing this investigational compound for these patients,” said Dr. Malte Peters, Chief Development Officer of MorphoSys AG.
With MorphoSys’s support through a licensing agreement in November 2017, I-Mab is currently leading the clinical development of MOR202/TJ202 in Greater China, including mainland China, Hong Kong, Macao and Taiwan. In addition to Taiwan, I-Mab has filed an investigational new drug (IND) application to China’s National Medical Products Administration in August 2018. Previously on March 20, 2019, MorphoSys and I-Mab announced the first patient dosing of MOR202/TJ202 in a phase 2 multi-center clinical study in Taiwan in patients with relapsed or refractory multiple myeloma.