On April 29, 2019 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, and MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), reported 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 TJ202/MOR202 in combination with lenalidomide in patients with relapsed or refractory multiple myeloma (Press release, I-Mab Biopharma, APR 29, 2019, View Source [SID1234535448]). I-Mab has the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.
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"The initiation of our first phase 3 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," said Dr. Joan Shen, M.D., Head of R&D at I-Mab. "In parallel with our pivotal phase 2 trial of TJ202/MOR202 in combination with dexamethasone, the phase 3 study will further assess the efficacy of TJ202/MOR202 as a potential second line treatment in MM."
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 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. The primary endpoint is to evaluate the progression-free survival (PFS) comparing the efficacy of TJ202/MOR202 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 TJ202/MOR202 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 TJ202/MOR202 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, I-Mab and MorphoSys announced the first patient dosing of TJ202/MOR202 in a phase 2 multi-center clinical study in Taiwan in patients with relapsed or refractory multiple myeloma.
About TJ202/MOR202
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, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, 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). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on an exclusive regional licensing agreement signed in late 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.