MorphoSys AG has announced that it 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 monoclonal Fc optimized anti-CD19 antibody to which MorphoSys gained worldwide access via an exclusive license and collaboration agreement with Xencor in 2010.
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.
"Due to its high expression levels on non-Hodgkin's lymphomas and B-cell leukemias CD19 represents a particularly attractive immunotherapy target for hematological cancers," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
Dr. Schottelius continued, "What is unique about MOR208 is that the antibody comprises only a very minor change to the Fc part of the molecule leading to significantly increased potency."
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 is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug Rituxan®.
Therefore targeting CD19 could potentially allow for an even broader therapeutic use of MOR208 than marketed anti-CD20 antibodies.