Merus N.V. announced the submission of an Investigational New Drug application to the U.S. Food and Drug Administration for MCLA-117 for the potential treatment of acute myeloid leukemia (AML) and the approval of a Clinical Trial Application (CTA) in Belgium for MCLA-158 for the potential treatment of metastatic colorectal cancer. Merus announced that it has submitted an IND application to the U.S.FDA for MCLA-117, the Company's T-Cell Engager Biclonics(®), designed to specifically bind to CD3, a cell-surface molecule present on T cells, and CLEC12A, a cell-surface molecule present on AML cells and stem cells. MCLA-117 is currently being studied in an ongoing Phase 1, first-in-human, dose escalation clinical trial in Europe in AML patients with relapse or refractory disease. Upon acceptance of the IND by the U.S.FDA, Merus plans to open sites for this trial in the United States. The Company also announced approval of a CTA in Belgium, one of the several European countries where Merus has filed a CTA and where it plans to first initiate a Phase 1, first-in-human clinical trial of MCLA-158. MCLA-158 is an ADCC-enhanced Biclonics(®) designed to bind to cancer stem cells expressing leucine-rich repeat-containing G protein-coupled receptor 5 (Lgr5) and epidermal growth factor receptors (EGFR). The trial, which will focus initially in patients with metastatic colorectal cancer, is anticipated to start during the first quarter of 2018. Merus plans to file an IND for MCLA-158 with the U.S.FDA in the first quarter of 2018.