MorphoSys AG, an international company develops HuCAL, the most successful antibody library technology in the pharmaceutical industry, has initiated patient enrollment in a phase II 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, multi-centre, single-arm clinical trial is designed to assess the efficacy of MOR208 in patients with relapsed or refractory NHL. 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). The trial is to be conducted at sites across both Europe and the US.
"In MOR208 we have a very exciting cancer programme 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 haematological malignancies," commented Dr Arndt Schottelius, chief development officer of MorphoSys AG. "Broadening the drug's development programme into additional indications is intended to maximize the value of this compound."
MOR208 showed encouraging signs of preliminary anti-tumour activity and an acceptable safety and tolerability profile in a phase I/IIa trial in patients with high-risk, heavily pretreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). In addition to the phase II trial in NHL, MorphoSys is currently evaluating the compound in a phase II trial in B-cell Acute Lymphoblastic Leukaemia (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.
MorphoSys developed HuCAL, the most successful antibody library technology in the pharmaceutical industry. By successfully applying this and other patented technologies, MorphoSys has become a leader in the field of therapeutic antibodies, one of the fastest-growing drug classes in human healthcare.