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     1420  0 Kommentare MorphoSys and Xencor Publish Final Results from Phase 1/2a Trial of MOR208 (XmAb5574) in CLL/SLL at ASH Annual Meeting

    MorphoSys AG / MorphoSys and Xencor Publish Final Results from Phase 1/2a Trial of MOR208 (XmAb5574) in CLL/SLL at ASH Annual Meeting . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

    Results Show Durable Responses in High Risk Patient Population

     

    MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Xencor Inc. (NASDAQ: XNCR) today announced the publication of final results of a Phase 1/2a trial evaluating MOR208 (formerly XmAb5574®) in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL). MOR208 is a potent anti-CD19 antibody with a proprietary modification to the Fc portion that is being developed to treat B-cell malignancies. MOR208 was in-licensed by MorphoSys from Xencor in 2010.

    The results demonstrate that the drug was well tolerated and achieved durable responses in a high risk and poor prognosis patient population with significant progression-free survival achieved:

    • At recommended dose 12 patients (75%) had a partial response by physical exam criteria (IWCLL 1996) and 6 patients (37.5%) had a partial response using additional CT criteria (IWCLL 2008)
    • Blood disease cleared in most patients, with median reduction in absolute lymphocyte count from baseline of 90.8%
    • Progression-free survival of up to 60 weeks for patients in extended treatment arm

    "The data presented by the Ohio State University and our collaboration partner Xencor complement the clinical results we will present tomorrow at ASH for MOR208 in NHL. In the meantime, Phase 2 clinical evaluation of MOR208 in CLL in combination with lenalidomide as well as in NHL and ALL is ongoing. Taken together the MOR208 program has advanced significantly in 2014 and the clinical evidence supporting this program is stronger than ever," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.

    "The activity observed with MOR208 in this difficult to treat population, particularly the durability and tolerability, position the program well for further development," said Bassil Dahiyat, President and CEO of Xencor. "Further, these data demonstrate the high anti-tumor activity that our cytotoxic XmAb® Fc domain creates in antibodies."

    The Phase 1/2a trial was designed to assess the drug's safety, tolerability, pharmacokinetic profile and preliminary anti-tumor activity. MOR208 was administered as an intravenous infusion on days 1, 4, 8, 15, and 22 of cycle 1, and on days 1, 8, 15, and 22 of cycle 2. Dose levels tested ranged from 0.3 to 12 mg/kg with an expansion to a total of 16 patients at the highest dose.

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    MorphoSys and Xencor Publish Final Results from Phase 1/2a Trial of MOR208 (XmAb5574) in CLL/SLL at ASH Annual Meeting MorphoSys AG / MorphoSys and Xencor Publish Final Results from Phase 1/2a Trial of MOR208 (XmAb5574) in CLL/SLL at ASH Annual Meeting . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content …

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