Merus Provides Clinical Updates for MCLA-117 and MCLA-158 Programs
- Category: Antibodies
- Published on Thursday, 04 January 2018 20:17
- Hits: 601
- IND submitted to U.S. FDA for MCLA-117 in AML -
- First CTA approval for MCLA-158 received in European country -
UTRECHT, The Netherlands I January 04, 2018 I Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) 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.
“The filing of an IND for MCLA-117 and the first CTA approval for MCLA-158 represent key steps forward for both programs as we continue to progress our robust pipeline of proprietary bispecific antibodies in the clinic with the goal of addressing significant unmet medical needs,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We look forward to the advancement of both Biclonics® in 2018, including the initiation a Phase 1 first-in-human trial of MCLA-158 in Belgium planned for this quarter.”
Merus today 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.
About Merus N.V.
Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have similar features as conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus’ most advanced bispecific antibody candidate, MCLA-128, is expected to soon be evaluated in a Phase 2 combination trial in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus’ second most advanced bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145, which is designed to bind to PD-L1 and a non-disclosed second immunomodulatory target and is being developed in collaboration with Incyte Corporation. For additional information, please visit Merus’ website, www.merus.nl.