MorphoSys AG has announced that it has dosed the first patient in a Phase 2 clinical trial of MOR208 in Non-Hodgkin's Lymphoma (NHL).
MOR208 is a potent Fc-optimized anti-CD19 antibody to which MorphoSys gained worldwide rights via an exclusive license and collaboration agreement with Xencor in 2010.
The open-label, multicenter, single-arm clinical trial is designed to assess the efficacy of MOR208 in patients with relapsed or refractory Non-Hodgkin's Lymphoma.
Secondary outcome measures include response duration, safety and pharmacokinetics of MOR208. A total of up to 120 patients are planned to be enrolled in four separate sub-indications (FL, MCL, DLBCL and other forms of indolent NHL).
More information on the trial can be found by searching for MOR208 at www.clinicaltrials.gov. The trial is to be conducted at sites across both Europe and the US.
"In MOR208 we have a very exciting cancer program with a huge potential. Evaluating MOR208 in NHL and B-ALL - building on the data we already have for CLL - should enable us to assess the therapeutic benefit and broader commercial potential of the molecule in hematological malignancies," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG.
Dr. Schottelius continued, "Broadening the drug's development program into additional indications is intended to maximize the value of this compound."
MOR208 showed encouraging signs of preliminary anti-tumor activity and an acceptable safety and tolerability profile in a Phase 1/2a trial in patients with high-risk, heavily pretreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
In addition to the phase 2 trial in NHL, MorphoSys is currently evaluating the compound in a phase 2 trial in B-cell Acute Lymphoblastic Leukemia (B-ALL).
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.