On March 19, 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 German biopharma company MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX;NASDAQ: MOR), reported that the first patient dosing (FPD) has been achieved in a phase 2 multi-center clinical study in Taiwan to evaluate an investigational human CD38 antibody TJ202/MOR202 in patients with relapsed or refractory multiple myeloma (Press release, I-Mab Biopharma, MAR 19, 2019, View Source [SID1234534473]). TJ202/MOR202 is an antibody developed by MorphoSys AG. I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Hong Kong, Macao and Taiwan.
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"Advancing TJ202/MOR202 into a late stage phase 2 trial is a significant achievement," said Dr. Joan Shen, M.D., Head of R&D at I-Mab. "We expect that, if approved, TJ202/MOR202 may provide multiple myeloma patients with an important biologics treatment option with its unique benefit that addresses the underlying pathology of the second most common blood cancer worldwide."
The dosing of the first patient triggers a milestone payment of USD 5 million to MorphoSys.
Under I-Mab’s fast-to-market development strategy, the study has been designed as a pivotal trial, which, if successful, could lead to a biologics license application (BLA) in Greater China. The multi-center, single-arm, phase 2 study will be conducted in mainland China and Taiwan to evaluate the efficacy and safety of TJ202/MOR202 in combination with dexamethasone in patients with relapsed or refractory multiple myeloma who have previously received at least two prior lines of treatment. The primary endpoint is to evaluate the objective response rate.
"We are delighted that our partner I-Mab has taken this important step in advancing TJ202/MOR202 into pivotal clinical development in Asia. We see a high medical need for the treatment of patients with multiple myeloma in the Greater China 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, which includes 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.
It should be noted that the recent court decision of the United States (U.S.) District Court of Delaware (1:16-cv-00221-LPS-CJB) has no bearing on the validity and scope of the patents exclusively licensed by I-Mab from MorphoSys AG, whose exclusivity provides protection for I-Mab’s development and commercialization of MOR202 in the Greater China region.
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 researches suggest that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.