arGEN-X Submits Investigational New Drug Application to Evaluate ARGX-110 in Waldenström’s Macroglobulinemia
arGEN-X N.V. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1b/2 trial of ARGX-110 in patients with relapsed or refractory Waldenström’s macroglobulinemia. ARGX-110 is a novel anti-CD70 antibody currently being evaluated in a Phase 1b study in hematological and solid cancers in Europe.
“The IND submission is a very important step in the clinical development of ARGX-110 and highlights our commitment to evaluate the drug in patients with orphan diseases and few treatment options. Based on a sound biological rationale, we are eager to advance ARGX-110 further in the clinic and plan to do so upon FDA’s decision,” said Alain Thibault, CMO of arGEN-X. “We feel fortunate to have support from The Leukemia & Lymphoma Society in developing this program in Waldenström’s macroglobulinemia and look forward to getting underway.”
The Phase 1b/2 study planned aims to enrol 30 patients and will be conducted at two leading cancer centers in the US: Dana-Farber Cancer Institute and Memorial Sloan Kettering Cancer Center. The principal investigator of the study is Steven P. Treon, MD, PhD, Director of the Bing Center for Waldenström’s macroglobulinemia at Harvard Medical School and a leading authority on the disease and its treatment. The trial is sponsored by the Leukemia & Lymphoma Society (LLS), under an agreement signed between LLS and arGEN-X in June 2014. The Phase 2 part of the study will assess overall safety and efficacy of ARGX-110 following a dedicated dose optimization (Phase 1b). Both phases will correlate an extensive panel of biomarkers with clinical outcome. Patient enrolment in the study is planned to start during the first quarter of 2015, to complete recruitment by 1H 2016, with efficacy results expected in 2017.
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