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MorphoSys, Xencor begin Phase 1 Anti-CD19 antibody study

MorphoSys and Xencor have initiated an open-label, multi-dose, single-arm, dose-escalation Phase 1 testing of MOR208 (XmAb5574) and has also dosed the first patient in the trial.

MOR208 (XmAb5574) is a potent monoclonal anti-CD19 antibody to which MorphoSys recently gained worldwide access via an exclusive license and collaboration agreement with Xencor.

MorphoSys and Xencor said the trial is designed to assess the drug’s safety, tolerability, pharmacokinetic profile and preliminary anti-tumor activity in chronic lymphocytic leukemia (CLL) patients.

The study is expected to enroll 30 patients suffering from relapsed or refractory CLL.

In preclinical studies, MOR208 (XmAb5574) was well tolerated at various dose levels, elicited immediate and sustained B-cell depletion, and showed strong anti-tumor potency, anti-proliferative and apoptotic activity.

MorphoSys chief development officer Arndt Schottelius said that with MOR208, their second proprietary compound enters clinical trials in addition to currently ten programs being developed in the clinic by their partners.

Xencor CEO Bassil Dahiyat said this is the fourth ADCC antibody based on their XmAb technology that has reached the clinic, demonstrating the tremendous progress their optimisation technologies have made in producing next-generation biological drugs.