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MOR208 is a humanized monoclonal antibody that targets the antigen CD19 for the treatment of B-cell malignancies.

B-cell malignancies, such as non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL) afflict 150,000 people in the seven major markets each year.

MOR208 is currently being evaluated as monotherapy in a phase 2a trial in relapsed/refractory patients with four different subtypes of NHL. Additionally, MorphoSys’s partner the Ohio State University is evaluating MOR208 in combination with lenalidomide in an investigator-sponsored trial phase 2 trial in CLL patients.

In 2015, MorphoSys plans to initiate two phase 2 clinical trials evaluating combinations of MOR208 with lenalidomide and bendamustine in diffuse large B-cell lymphoma (DLBCL). Additionally, a new investigator-sponsored pediatric trial using MOR208 in combination with an immune cell transplantation for children with ALL is in preparation.

MOR208 has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumor cell killing and offering potential for enhanced efficacy compared to traditional antibodies for the treatment of cancer.

In a phase 1/2a-trial, MOR208 has shown 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).

Recent preliminary data presented today at ASCO 2015 showed that MOR208 is well tolerated with a low level of infusion reactions and demonstrates encouraging single-agent activity. The clinical data summarized efficacy and safety results for 92 heavily pre-treated patients. The overall response rate was 28% across all four subtypes of NHL and reached 36% in the DLBCL subgroup (both based on evaluable patients). At the time of the interim analysis, the majority of responders – 16 out of 21 – had an ongoing response to the treatment. The longest response duration observed so far exceeded 14.2 months in DLBCL, 15.4 months in FL and 10.8 months in other iNHL.

The MOR208 target (CD19) is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug rituximab, therefore potentially allowing for an even broader use of MOR208 as compared to rituximab.

In June 2010, MorphoSys AG and the Xencor, Inc. signed a worldwide exclusive license agreement for the antibody. The agreement provided MorphoSys with an exclusive worldwide license to XmAb5574, which was subsequently renamed MOR208.

MOR208 was granted orphan drug designation in DLBCL (US and Europa) and CLL (US and Europe). Additionally, the FDA has granted fast track designation for the treatment of DLBCL.

Poster clinical phase 2 data of MOR208 in NHL presented at the 2015 ASH Annual Meeting
(PDF, 690 KB)
Poster clinical phase 2 data of MOR208 in combination with lenalidomide in CLL presented at the 2015 ASH Annual Meeting (Ohio State University)
(PDF, 1 MB)
Presentation on updated clinical phase 2 data in NHL presented at the 2015 ASCO Annual Meeting
(PDF, 610 KB)
Poster final clinical phase 1 data in CLL presented at the 2014 ASH Annual Meeting
(PDF, 0.7 MB)