Date: 2014-11-03
Type of information: Submission of a clinical trial application
phase: 1b-2
Announcement: Submission of a clinical trial application
Company: Argen-X (Belgium)
Product: ARGX-110
Action
mechanism: monoclonal antibody/immune checkpoint inhibitor. ARGX-110 is a SIMPLE Antibody™ targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. ARGX-110 works in three ways: i) blocks growth of tumor cells, ii) kills cancer cells and iii) restores immune surveillance against tumors (ref. 1). ARGX-110 is currently being evaluated in hematological and solid tumors in a Phase 1b study in Europe and will be developed in partnership with the Leukemia & Lymphoma Society (LLS) for the rare lymphoma Waldenström’s macroglobulinemia.
Disease: relapsed or refractory Waldenström’s macroglobulinemia
Therapeutic area: Cancer - Oncology - Rare diseases
Country: USA
Trial details:
Latest
news: * On November 3, 2014, arGEN-X, a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, announced the submission of an Investigational New Drug (IND) application to the FDA to initiate a Phase 1b/2 trial of ARGX-110 in patients with relapsed or refractory Waldenström’s macroglobulinemia. The Phase 1b/2 study planned aims to enroll 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 enrollment 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.
