Foundation Medicine, Inc. today announced a collaboration to develop Foundation Medicine’s RNA platform as a companion diagnostic for Merus N.V.’s (Nasdaq: MRUS) bispecific antibody zenocutuzumab (Zeno) to treat patients with neuregulin 1 fusion (NRG1+) cancer.

Zeno is a Biclonics® that utilizes the Merus Dock & Block® mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival.

In May the U.S. Food and Drug Administration (FDA) accepted under priority review a Biologics License Application for Zeno in patients with NRG1+ non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer. The FDA has also granted Breakthrough Therapy Designation (BTD) to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy.

NRG1 gene fusions are rare and have been identified in patients with different types of solid tumors, including NSCLC, pancreatic cancer, gallbladder cancer, renal cell carcinoma, bladder cancer, ovarian cancer, breast cancer, neuroendocrine tumor, sarcoma, and colorectal cancer.¹ NRG1 fusions are unique cancer drivers that create oncogenic chimeric ligands rather than the more widely described chimeric receptors (NTRK, RET, ROS1, ALK, and FGFR fusions).²

While DNA sequencing with optimized targeting can detect fusions, Foundation Medicine’s RNA platform can provide another layer of sophisticated fusion detection in 318 genes through RNA sequencing. It also has expanded capabilities for research use to offer gene expression reporting of over 1,500 genes to support biomarker discovery. Foundation Medicine is the only company with FDA-approved CDx indications for fusion biomarkers using CGP tests, including approved claims using tissue or liquid biopsy for ALK, ROS1, RET, NTRK1/2/3, and FGFR2.³

“We are excited to partner with Merus on this RNA companion diagnostic opportunity to provide fusion detection through next-generation sequencing,” says Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “We anticipate this innovative molecular information will help detect more NRG1 fusions and provide healthcare providers with important information to inform their care decisions for patients.”

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on LinkedIn and X.

¹ Jonna S, Feldman RA, Swensen J, et al. Detection of NRG1 gene fusions in solid tumors. Clin Cancer Res. 2019;25(16):4966-4972. doi: 10.1158/1078-0432.CCR-19-0160.

² Suda K, Mitsudomi T. Emerging oncogenic fusions other than ALK, ROS1, RET, and NTRK in NSCLC and the role of fusions as resistance mechanisms to targeted therapy. Transl Lung Cancer Res. 2020;9(6):2618-2628. doi:10.21037/tlcr-20-186

³ Data on file, Foundation Medicine, Inc. as of 2024.

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