Rare NRG1 Fusion Market Size to Exhibit Moderate Growth by 2034, Evaluates DelveInsight

DelveInsight's "Rare NRG1 Fusion Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Rare NRG1 Fusion, historical and forecasted epidemiology as well as the Rare NRG1 Fusion market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Rare NRG1 Fusion Market Report
• Among the 7MM, the US accounted for the highest incident cases of NRG1 Fusion in 2023.
• In 2023, the total Incident cases of NRG1 Fusion were approximately 2,000 cases in the US, which is expected to grow during the forecast period.
• Among EU4 and the UK, Germany accounted for the highest number of NRG1 Fusion Incident cases, while Spain accounted for the least Incident cases.
• Among the stage-specific incident cases of NRG1 Fusion, metastatic cases contribute the most in the US.
• NSCLC accounts for around 40% of total treated cases of NRG1 Fusions in 2023.
• The leading Rare NRG1 Fusion Companies such as Elevation Oncology, Merus, Hummingbird Bioscience, Boehringer Ingelheim, AVEO Oncology and CANbridge Pharmaceuticals, Salubris Biotherapeutics, and others.
• Promising Rare NRG1 Fusion Companies such as Seribantumab (MM-121), Zenocutuzumab (Zeno, MCLA-128), HMBD-001, Afatinib, AV-203 (CAN017), JK07, and others.

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Rare NRG1 Fusion Drugs Market Landscape
The landscape of NRG1 Fusion drug development involves HER3 inhibitor/ERBB-3 receptor antagonists, Tyrosine kinase inhibitor. ERBB family members including epidermal growth factor receptor (EGFR) also known as HER1, ERBB2/HER2/Neu, ERBB3/HER3 and ERBB4/HER4 are aberrantly activated in multiple cancers and hence serve as drug targets and biomarkers in modern precision therapy. The therapeutic potential of HER3 has long been underappreciated, due to impaired kinase activity and relatively low expression in tumors. However, HER3 has received attention in recent years as it is a crucial heterodimeric partner for other EGFR family members and has the potential to regulate EGFR/HER2-mediated resistance.

Rare NRG1 Fusion Epidemiology Segmentation in the 7MM
• Incident cases of specific cancer types (lung, pancreatic, breast, and others
• Diagnosed and Treatable Cases in the respective cancer types
• Incident cases of Rare NRG1 Fusion in the respective cancer types

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Rare NRG1 Fusion Emerging Drugs

• Seribantumab (MM-121): Elevation Oncology
Seribantumab (MM-121) is a fully human monoclonal antibody by Elevation Oncology. It is designed to stop the HER3 signaling that sustains an NRG1 fusion-positive tumor. Seribantumab binds to HER3, so the NRG1 fusion protein that over-activates it cannot bind to it. Seribantumab is being developed as a precise treatment path for patients whose tumor growth is driven by an NRG1 fusion. Seribantumab is currently in the Phase II CRESTONE study clinical development stage. It is now being studied in patients with solid tumors of any origin that test positive for an NRG1 fusion. The topline data from the CRESTONE Phase II study was presented at AACR Annual meeting 2023.

• Zenocutuzumab (MCLA-128): Merus
Zenocutuzumab (MCLA-128) is an experimental medicine developed by Merus. It blocks the action of the growth factor NRG1, a protein that can be overproduced due to NRG1 fusions, and prohibits it from binding to HER3. It is a bispecific antibody, i.e., it can recognize two different proteins, specifically HER2 and HER3. It is designed to have a dock and block mechanism. First, zenocutuzumab (MCLA-128) docks onto HER2, which then leads to blocking HER3's ability to bind NRG1. Currently, zenocutuzumab is in the Phase II clinical development stage to treat NRG1 fusion solid tumors. This trial is a Phase I/II study of MCLA-128, a full-length IgG1 bispecific antibody targeting HER2 and HER3, in solid tumors patients and is still in the recruiting stage for the Phase II part of the trial. Merus also announced initial clinical data for three patients with cancers harboring NRG1 fusions treated with MCLA-128 through EAP.

Rare NRG1 Fusion Market Outlook
NRG1 fusions have been identified in over 10 solid tumor types, making it a strong candidate for a tumor-agnostic development approach. Moreover, an increase in awareness, research, and development can be seen in this area making it an attractive opportunity for the key players. Several ERBB3 inhibitors showing promising preclinical data are currently in different phases of clinical trials. Several of these are being tested in combination with ERBB2-targeting drugs in breast and gastric ERBB2-positive tumors.

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Rare NRG1 Fusion Treatment Market Landscape
Cancer treatment is the use of surgery, radiation, medications and other therapies to cure a cancer, shrink a cancer or stop the progression of a cancer. There are many types of cancer treatment. The types of treatment that a patient receives will depend on the type of cancer they have and how advanced it is. Some people with cancer will have only one treatment. But most people have a combination of treatments, such as surgery with chemotherapy and/or radiation therapy. Cancer treatments may be used as primary treatment, adjuvant treatment and palliative treatment.

Rare NRG1 Fusion Drugs Uptake
• Elevation Oncology is developing Seribantumab (MM-121), a fully human monoclonal antibody designed to stop the HER3 signaling that sustains an NRG1 fusion-positive tumor. The drug binds to HER3 to restrict its over activation by the NRG1 fusion protein. The company believes that their potential drug candidate may offer a precise treatment path forward for patients whose tumor growth is driven by an NRG1 fusion. The drug also interferes with the dimerization of HER3 with other ERBB family members and blocks the phosphorylation of all ERBB family members and activation of the PI3K and MAPK downstream signaling pathways. The drug was originally developed and tested by Merrimack Pharmaceuticals who sold the drug to Elevation Oncology.

• Merus is developing Zenocutuzumab (Zeno, MCLA-128) in patients with solid tumors harboring an NRG1fusion. MCLA-128 is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that targetsthe HER3 pathway. The bispecific antibody docks on HER2, abundantly expressed on tumor cells, andsubsequently efficiently blocks heregulin-stimulated growth of tumor cells by binding to HER3. The drug isdesigned to overcome the inherent and acquired resistance of tumor cells to HER2-targeted therapies using twomechanisms: 1) blocking growth and survival pathways to stop tumor expansion and 2) recruitment andenhancement of immune effector cells to eliminate the tumor. In July 2020, the US FDA grantedOrphan DrugDesignation to Zenocutuzumab for the treatment of patients with pancreatic cancer. The drug also receivedaFast Track designation for zenocutuzumab in the US for the treatment of patients with metastatic solid tumorsharboring NRG1 gene fusions.

• Hummingbird Bioscience's HMBD-001 represents a unique, highly-specific, anti-HER3 neutralizing antibody witha novel mechanism of action that offers significant potential for broad clinical benefit. Pre-clinical models haveshown that HMBD-001 is able to effectively and uniquely bind to a difficult-to-target region on HER3, blockingthe heterodimerization of HER3 with HER2/EGFR independent of NRG1 binding. This potently inhibits theactivation of the signaling pathway - and consequently, stops tumor growth. HMBD-001 was developed usingHummingbird Bioscience's proprietary Rational Antibody Discovery Platform to specifically bind to and inhibit adifficult-to-access region of the HER3 protein that is essential for activation. Cancer Research UK has partneredwith Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer.

Rare NRG1 Fusion Market Dynamics
The rare NRG1 fusion market dynamics are anticipated to change in the coming years. The identification of NRG1 as a potential target for treating different types of cancer, particularly NRG1+ NSCLC, has showcased a major strength in the rare NRG1 fusion market. Studies confirm that drugs aimed at NRG1 are positively impacting patients, leading to an increasing focus by various organizations on understanding and disseminating information about the role of NRG1 Fusion in cancer. This growing attention positions NRG1 fusions as a crucial target for innovative therapies, thereby paving the way for new treatments and a market boost focused on NRG1 fusion-specific therapies.

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Scope of the Rare NRG1 Fusion Market Report
• Coverage- 7MM
• Study Period- 2020-2034
• Rare NRG1 Fusion Companies- Elevation Oncology, Merus, Hummingbird Bioscience, Boehringer Ingelheim, AVEO Oncology and CANbridge Pharmaceuticals, Salubris Biotherapeutics, and others.
• Rare NRG1 Fusion Companies- Seribantumab (MM-121), Zenocutuzumab (Zeno, MCLA-128), HMBD-001, Afatinib, AV-203 (CAN017), JK07, and others.
• Rare NRG1 Fusion Market Dynamics: Rare NRG1 Fusion Market Drivers and Barriers
• Rare NRG1 Fusion Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Content
1 Key Insights
2 Report Introduction
3 Executive summary
4 Key Events
5 Epidemiology and Market Methodology
6 Rare NRG1 Fusion Market Overview at a Glance
7 Disease Background and Overview
8 Treatment and Management
9 Epidemiology and Patient Population of the 7MM
10 Patient Journey
11 Emerging Therapies
Full list of emerging drugs will be provided in the report
12 Rare NRG1 Fusion: 7 Major Market Analysis
13 Unmet Needs
14 SWOT Analysis
15 KOL Views
16 Market Access and Reimbursement
17 Appendix
18 DelveInsight Capabilities
19 Disclaimer
20 About DelveInsight

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