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Monoclonal Antibody with Xencor's High ADCC Fc Technology Enters Phase 2 Study in B-cell Acute Lymphoblastic Leukemia
Date:4/26/2013

MONROVIA, Calif., April 26, 2013 /PRNewswire/ -- Xencor announced today that MorphoSys AG has dosed the first patient in a Phase 2 clinical trial of MOR208 in B-cell acute lymphoblastic leukemia (B-ALL). MOR208 is a potent anti-CD19 monoclonal antibody Fc optimized for high cytotoxic function for which MorphoSys licensed exclusive worldwide rights from Xencor in 2010. The dosing of the first patient in the study triggers an undisclosed milestone payment to Xencor.

The US-based study is an open-label, multicenter, single-arm clinical trial designed to assess the efficacy of MOR208 in patients suffering from relapsed or refractory B-ALL. Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. In total, 30 patients are planned to be enrolled. More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov.

"Preclinical and early clinical studies of MOR208 have shown promising anti-tumor activity and supported this additional study in ALL as well as another study in Non Hodgkin's Lymphoma which is expected to start shortly," said Bassil Dahiyat , Ph.D., Chief Executive Officer of Xencor. "Xencor monoclonal antibody candidates continue to advance in clinical development and showcase the value of our XmAb® Fc technology."

MOR208 has shown in a Phase 1/2a trial encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In addition to the phase 2 trial in B-ALL MorphoSys is about to start a second Phase 2 trial in Non-Hodgkin's Lymphoma (NHL).

B-cell malignancies, such as B-ALL, NHL and CLL affect more than one hundred and fifty thousand patients in the seven major markets each year. The target molecule CD19
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