MorphoSys has announced dosing of the first patient in its Phase II trial of MOR208 in patients with B-cell acute lymphoblastic leukemia (B-ALL).
The potent monoclonal Fc optimised anti-CD19 antibody, MOR208, will be assessed for its effectiveness in patients suffering from relapsed or refractory B-ALL.
Response duration, safety and pharmacokinetics are the secondary outcome measures of the open-label, US-based multicentre trial.
The single-arm clinical trial will enrol a total of 30 patients.
MorphoSys chief development officer Dr Arndt Schottelius said CD19 is a good immunotherapy target for haematological cancers due to its high expression levels on non-Hodgkin's lymphomas and B-cell leukemias.
"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," Schottelius said.
A previous Phase I/IIa trial demonstrated preliminary anti-tumour activity and an acceptable safety and tolerability profile of MOR208 in patients with high-risk, heavily pretreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
The company expects to start a Phase II trial to assess the drug as a treatment for Non-Hodgkin's Lymphoma (NHL).
As the target molecule CD19 is expressed more broadly and earlier in B-cell development than CD20, the company believes targeting CD19 could potentially enable a broader therapeutic use of MOR208 than marketed anti-CD20 antibodies.
Image: A Wright's stained bone marrow aspirate smear of patient with precursor B-cell acute lymphoblastic leukemia. Photo: Courtesy of Vashi Donsk.