Merus Announces IND Clearance for MCLA-145

MCLA-145 is a full-length human bispecific antibody binding to PD-L1 and CD137

UTRECHT, The Netherlands I January 07, 2019 I Merus N.V. (Nasdaq: MRUS), a clinical-stage immuno-oncology company developing Biclonics®, innovative full-length human bispecific antibody therapeutics, today announced the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for MCLA-145, a first-in-class PD-L1 x CD137 Biclonics® being developed in collaboration with Incyte (Nasdaq: INCY), for the treatment of solid tumors. 

“We are pleased to announce the IND authorization to proceed from the FDA and to disclose more details around our latest Biclonics® program today,” said Andres Sirulnik, M.D., Ph. D., Executive Vice President and Chief Medical Officer of Merus. “Our preclinical work has demonstrated that MCLA-145 has the potential to overcome the known side effects of CD137 agonists currently in development and to address a significant unmet need in patient populations not benefitting from current immunotherapeutic agents. We expect to initiate the clinical trial program for MCLA-145 during the second quarter of 2019 and we look forward to continuing our collaboration with Incyte on MCLA-145’s global development.”          

Discovered through an unbiased functional screening of multiple immunomodulatory target combinations, MCLA-145 is a Biclonics® T-cell agonist that binds with high affinity and specificity to human PD-L1 and CD137 in preclinical models. The unique immunostimulatory profile of MCLA-145 derives from the ability to potently activate immune effector cells in the context of the tumor microenvironment while simultaneously blocking inhibitory signals in the same immune cell population.

Merus is developing MCLA-145 as part of a collaboration entered into with Incyte in December 2016 to potentially develop and commercialize up to 11 bispecific and monospecific antibodies from the Merus Biclonics® platform. Under the terms of the collaboration, Merus will retain all rights to develop and commercialize MCLA-145, if approved, in the United States, while Incyte has rights to develop and commercialize MCLA-145, if approved, outside the United States.

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 and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, www.merus.nl.

SOURCE: Merus

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