argenx launches Phase I/II study of ARGX-110 in combination with azacitidine in newly diagnosed AML patients
15 December 2016, Breda, the Netherlands / Ghent, Belgium – argenx today announced the initiation of a Phase I/II clinical trial of ARGX-110 in combination with azacitidine in newly diagnosed, elderly acute myeloid leukemia (AML) patients. ARGX-110 is the Company’s SIMPLE Antibody(TM) targeting CD70. Azacitidine is a hypomethylating agent that upregulates CD70 expression on AML blasts, and is currently the standard of care treatment for elderly AML patients.
“AML blasts and leukemic stem cells of newly diagnosed AML patients strongly overexpress CD70, regardless genetic factors or risk class. Targeting CD70 has proven to be a very promising therapeutic approach in various preclinical models of AML. The idea of combining ARGX-110 with the current standard of care azacitidine, which seems to sensitize cancer cells to a CD70 treatment, is an exciting one since it allows us to go into the first-line therapy setting,” commented Tim Van Hauwermeiren, CEO of argenx. “This trial marks the first combination study for ARGX-110. We believe that combination therapies for cancer will be a mainstay approach to enhance synergistic mechanisms and we are eager to see how ARGX-110 and azacitidine may support this hypothesis in newly diagnosed AML patients.”
The Phase I/II trial is an open-label, dose-escalating study (Phase I) with a proof-of-concept cohort (Phase II). In this Phase I study safety and tolerability will be determined whilst for the Phase II efficacy will be assessed in up to 42 newly diagnosed AML patients in total. Top-line data from the dose escalation are expected in about 18 months.