Foundation Medicine Collaborates With Merus to Advance Treatment Options in NRG1 Fusion-Driven Tumors Using Foundation Medicine’s RNA Platform
Foundation Medicine has announced a collaboration with Merus N.V. (Nasdaq: MRUS) to develop an RNA platform as a companion diagnostic for Merus's bispecific antibody zenocutuzumab (Zeno). This diagnostic aims to treat patients with neuregulin 1 fusion (NRG1+) cancer. Zeno, which utilizes Merus's Dock & Block® mechanism, inhibits the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions.
The FDA has accepted a Biologics License Application for Zeno under priority review for NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer (PDAC). Zeno has also received Breakthrough Therapy Designation for advanced unresectable or metastatic NRG1+ pancreatic cancer and NSCLC. Foundation Medicine's RNA platform offers sophisticated fusion detection in 318 genes through RNA sequencing, potentially helping to detect more NRG1 fusions and inform patient care decisions.
Foundation Medicine ha annunciato una collaborazione con Merus N.V. (Nasdaq: MRUS) per sviluppare una piattaforma RNA come diagnostica complementare per l'anticorpo bispecifico di Merus, zenocutuzumab (Zeno). Questa diagnostica è volta a trattare i pazienti con cancro da fusione di neuregulina 1 (NRG1+). Zeno, che utilizza il meccanismo Dock & Block® di Merus, inibisce la via di segnalazione tumorale neuregulina/HER3 in tumori solidi con fusione NRG1.
La FDA ha accettato una Domanda di Licenza Biologica per Zeno sotto revisione prioritaria per cancro polmonare non a piccole cellule (NSCLC) NRG1+ e cancro pancreatico (PDAC) NRG1+. Zeno ha inoltre ricevuto la Designazione di Terapia Innovativa per cancro pancreatico NRG1+ avanzato, irresecabile o metastatico e NSCLC. La piattaforma RNA di Foundation Medicine offre una sofisticata rilevazione delle fusioni in 318 geni attraverso il sequenziamento RNA, potenzialmente aiutando a rilevare più fusioni NRG1 e a informare le decisioni di cura del paziente.
Foundation Medicine ha anunciado una colaboración con Merus N.V. (Nasdaq: MRUS) para desarrollar una plataforma de ARN como diagnóstico complementario para el anticuerpo biespecífico de Merus, zenocutuzumab (Zeno). Este diagnóstico tiene como objetivo tratar a pacientes con cáncer por fusión de neuregulina 1 (NRG1+). Zeno, que utiliza el mecanismo Dock & Block® de Merus, inhibe la vía de señalización tumoral neuregulina/HER3 en tumores sólidos con fusiones de NRG1.
La FDA ha aceptado una Solicitud de Licencia Biológica para Zeno bajo revisión prioritaria para cáncer de pulmón no microcítico (NSCLC) NRG1+ y cáncer pancreático (PDAC) NRG1+. Zeno también ha recibido la Designación de Terapia Innovadora para cáncer pancreático NRG1+ avanzado, irresecable o metastásico y NSCLC. La plataforma de ARN de Foundation Medicine ofrece detección sofisticada de fusiones en 318 genes mediante secuenciación de ARN, lo que potencialmente ayuda a detectar más fusiones NRG1 e informar decisiones sobre la atención al paciente.
파운데이션 메디슨(Foundation Medicine)은 Merus N.V. (Nasdaq: MRUS)와 협력하여 Merus의 이중 특이항체 제노쿠투주맙(젠노, Zeno)의 보조 진단용 RNA 플랫폼을 개발한다고 발표했습니다. 이 진단은 뉴레귤린 1 융합(NRG1+) 암 환자를 치료하는 것을 목표로 합니다. Zeno는 Merus의 Dock & Block® 메커니즘을 활용하여 NRG1 융합이 있는 고형 종양에서 뉴레귤린/HER3 종양 신호 경로를 억제합니다.
FDA는 NRG1+ 비소세포 폐암(NSCLC) 및 NRG1+ 췌장암(PDAC)에 대해 Zeno의 생물학적 제제 면허 신청서를 우선 심사로 수락했습니다. Zeno는 또한 전이성이거나 수술할 수 없는 NRG1+ 췌장암 및 NSCLC에 대해 혁신 치료제 지정을 받았습니다. 파운데이션 메디슨의 RNA 플랫폼은 RNA 시퀀싱을 통해 318개의 유전자에서 정교한 융합 탐지를 제공하며, 이는 NRG1 융합을 더 많이 감지하고 환자 치료 결정을 알리는 데 도움을 줄 수 있습니다.
Foundation Medicine a annoncé une collaboration avec Merus N.V. (Nasdaq: MRUS) pour développer une plateforme d'ARN en tant que diagnostic d'accompagnement pour l'anticorps bispécifique de Merus, zenocutuzumab (Zeno). Ce diagnostic vise à traiter les patients atteints de cancer par fusion de la neureguline 1 (NRG1+). Zeno, qui utilise le mécanisme Dock & Block® de Merus, inhibe la voie de signalisation tumorale neureguline/HER3 dans les tumeurs solides présentant des fusions NRG1.
La FDA a accepté une Demande de Licence Biologique pour Zeno sous examen prioritaire pour cancer du poumon non à petites cellules (NSCLC) NRG1+ et cancer du pancréas (PDAC) NRG1+. Zeno a également reçu la Désignation de Thérapie Innovante pour le cancer du pancréas NRG1+ avancé, irrésectable ou métastatique et NSCLC. La plateforme ARN de Foundation Medicine propose une détection sophistiquée des fusions dans 318 gènes grâce au séquençage de l'ARN, ce qui pourrait aider à détecter davantage de fusions NRG1 et à informer les décisions de soins aux patients.
Foundation Medicine hat eine Zusammenarbeit mit Merus N.V. (Nasdaq: MRUS) bekannt gegeben, um eine RNA-Plattform als Begleitdiagnostik für den bispezifischen Antikörper Zenocutuzumab (Zeno) von Merus zu entwickeln. Diese Diagnostik zielt darauf ab, Patienten mit Neuregulin-1-Fusion (NRG1+) Krebs zu behandeln. Zeno, das den Dock & Block®-Mechanismus von Merus nutzt, hemmt den Neuregulin/HER3-Tumorsignalweg in soliden Tumoren mit NRG1-Fusionen.
Die FDA hat einen Antrag auf biologische Lizenz für Zeno unter Prioritätsprüfung für NRG1+ nicht-kleinzelliges Lungenkarzinom (NSCLC) und NRG1+ Bauchspeicheldrüsenkrebs (PDAC) angenommen. Zeno hat auch die Auszeichnung als Durchbruchtherapie für fortgeschrittenen, nicht operablen oder metastasierenden NRG1+ Bauchspeicheldrüsenkrebs und NSCLC erhalten. Die RNA-Plattform von Foundation Medicine bietet eine ausgeklügelte Fusionserkennung in 318 Genen durch RNA-Sequenzierung und könnte helfen, mehr NRG1-Fusionen zu erkennen und Entscheidungen zur Patientenversorgung zu informieren.
- FDA accepted Biologics License Application for Zeno under priority review for NRG1+ NSCLC and PDAC
- Zeno received Breakthrough Therapy Designation for advanced NRG1+ pancreatic cancer and NSCLC
- Foundation Medicine's RNA platform can detect fusions in 318 genes, potentially improving NRG1 fusion detection
- None.
This collaboration between Foundation Medicine and Merus is a significant step in advancing precision medicine for rare NRG1 fusion-driven cancers. The development of Foundation Medicine's RNA platform as a companion diagnostic for zenocutuzumab (Zeno) could potentially improve patient identification and treatment outcomes.
Key points to consider:
- Zeno's unique Dock & Block® mechanism targets the neuregulin/HER3 pathway, showing promise in preclinical studies.
- The FDA's priority review and Breakthrough Therapy Designations for Zeno in NRG1+ NSCLC and pancreatic cancer underscore its potential impact.
- Foundation Medicine's RNA platform offers enhanced fusion detection capabilities, which could lead to more accurate patient selection for targeted therapies.
This partnership could potentially accelerate the development of targeted treatments for patients with options, representing a positive step in personalized cancer care.
The collaboration between Foundation Medicine and Merus is a promising development in the field of precision oncology. NRG1 fusions, although rare, are found across various solid tumors and represent a unique class of cancer drivers. The potential of zenocutuzumab (Zeno) to target these fusions effectively could be a game-changer for patients with treatment options.
Key considerations:
- Zeno's mechanism of action, blocking HER2/HER3 heterodimer formation, addresses a specific oncogenic pathway.
- The FDA's priority review and Breakthrough Therapy Designations highlight the unmet medical need in NRG1+ cancers.
- Foundation Medicine's RNA platform could significantly improve the identification of NRG1 fusions, potentially expanding the patient population who could benefit from Zeno.
This collaboration exemplifies the ongoing shift towards biomarker-driven, personalized cancer treatments, which could lead to improved outcomes for patients with these rare genetic alterations.
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.
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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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FAQ
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