Shanghai-based biotech company I-Mab Biopharma reported on Tuesday the submission of an investigational new drug (IND) application to China National Drug Administration (CNDA) for TJ202/MOR202 for the treatment of multiple myeloma,the second most common blood cancer worldwide.
The filing is in alliance with its licensee MorphoSys AG (FSE:MOR)(NASDAQ:MOR), a German biopharma company.
TJ202/MOR202 is a monoclonal antibody derived from MorphoSys's HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, and, according to its suggested mode of action, recruits cells of the body's immune system to kill the tumour.
Additionally, the scientific research suggest that an anti-CD38 antibody may have therapeutic potential in other cancers, as well as autoimmune diseases. China recently issued a new round of reform initiatives to accelerate clinical trial approval for new drugs, especially in oncology.
After observing patient responses in an interim analysis from an ongoing Phase I/IIa trial in patients with relapsed/refractory MM in Germany and Austria, MorphoSys decided to support I-Mab to lead clinical development of TJ202/MOR202 in Greater China.
In conjunction with the agreement, MorphoSys will continue to evaluate additional other suitable indications for further global development of TJ202/MOR202.
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