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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataA 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.
