Foundation Medicine Partners with Merus to Improve NRG1 Fusion Tumor Treatments via RNA Platform

Foundation Medicine, Inc. has announced a new collaboration aimed at developing an RNA platform as a companion diagnostic for Merus N.V.’s bispecific antibody, zenocutuzumab (Zeno). The focus is on treating patients with cancers that possess neuregulin 1 gene fusions (NRG1+). Zeno, which utilizes Merus’ Dock & Block® mechanism, aims to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions. By binding to HER2 and effectively blocking HER3's interaction with its ligand NRG1, Zeno potentially offers a powerful treatment against NRG1+ cancers.

Preclinical studies have shown that Zeno is effective at inhibiting the formation of HER2/HER3 heterodimers, which are crucial for oncogenic signaling pathways. This action subsequently leads to the inhibition of tumor cell proliferation and survival. The advanced therapeutic capabilities of Zeno have not gone unnoticed; the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application for Zeno under priority review for treating patients with NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer (PDAC). Additionally, the FDA has granted Breakthrough Therapy Designation (BTD) to Zeno for patients with advanced, unresectable, or metastatic NRG1+ pancreatic cancer, as well as for those with advanced NSCLC who have progressed despite prior systemic therapies.

NRG1 gene fusions are quite rare but significant, occurring in various types of solid tumors, including NSCLC, pancreatic cancer, gallbladder cancer, renal cell carcinoma, bladder cancer, ovarian cancer, breast cancer, neuroendocrine tumors, sarcomas, and colorectal cancer. These fusions are unique cancer drivers as they create oncogenic chimeric ligands, unlike the more common chimeric receptors seen in other gene fusions such as NTRK, RET, ROS1, ALK, and FGFR.

While DNA sequencing can detect these fusions with optimized targeting, Foundation Medicine’s RNA platform offers an additional layer of sophistication. This RNA sequencing platform can detect fusions in 318 genes and even provide gene expression reporting for over 1,500 genes to support biomarker discovery. Foundation Medicine is notable for being the only company with FDA-approved companion diagnostic (CDx) indications for fusion biomarkers using comprehensive genomic profiling (CGP) tests, with approved claims for tissue or liquid biopsy in ALK, ROS1, RET, NTRK1/2/3, and FGFR2.

Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine, expressed excitement about this partnership with Merus. He emphasized that this innovative molecular information from RNA sequencing is expected to enhance the detection of NRG1 fusions, thus providing vital information for healthcare providers to make informed treatment decisions.

Foundation Medicine is a leader in molecular profiling for cancer, collaborating with a wide range of partners to set high standards in quality, scientific excellence, and regulatory leadership. The company's deep understanding of cancer biology aids physicians in making informed treatment decisions and empowers researchers to develop new medicines. Their commitment is driven by the goal of enabling more patients worldwide to benefit from precision cancer care.