Merus Granted FDA Fast Track Designation of Zenocutuzumab for the Treatment of Patients with Neuregulin 1 Fusion Cancers

Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics^® and Triclonics™) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy.

Fast Track is a designation granted by the FDA that is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

NRG1 gene fusions are a group of rare genomic alterations emerging as potential actionable drivers of tumorigenesis and growth across many types of solid tumors, including lung, breast, pancreatic, ovarian, and colorectal cancers. Merus is currently enrolling patients into the Phase 1/2 eNRGy trial evaluating Zeno monotherapy in patients with NRG1+ cancers, in three cohorts: non-small cell lung cancer; pancreatic cancer; and other solid tumors.

“Receiving Fast Track Designation is another important milestone for Zeno, and it validates the potential for addressing the unmet need of patients with NRG1+ cancers,” said Andrew Joe, MD, Chief Medical Officer. “We continue to add clinical trial sites to and enroll patients in the eNRGy trial and look forward to providing a substantial clinical program update at a major medical meeting in the second quarter of 2021.”

About Merus N.V.
Merus is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics^®. Multiclonics^® 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’.

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