Frontier Pharma: Head and Neck Cancer - Immunotherapies and Signal Transduction Inhibitors Dominate First-in-Class Innovation


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78pages

GBI Research

$ 6995

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Head and neck squamous cell carcinoma is the sixth most common cancer, and its incidence is rising. The term head and neck cancer (HNC) comprises a number of malignancies that usually begin in the squamous cells that line the moist, mucosal surfaces inside the head and neck. These cancers develop inside the mouth, nose and throat. The annual incidence of head and neck cancers worldwide is more than 550,000 cases, with around 300,000 related deaths. Peak incidence occurs between the ages of 55 and 64.

The HNC market is characterized by a small selection of marketed product options, consisting of chemotherapies, cancer immunotherapies and receptor tyrosine kinase inhibitor products. The pipeline is moderately sized, with 340 products active across all stages of development. First-in-class products only constitute approximately a third of the pipeline, and represent 39% of products with a disclosed target. The most widely studied group of first-in-class targets are cancer immunotherapies. This has been heavily influenced by the success of Opdivo and Keytruda, which are used in the treatment of HNC (after 2016 FDA approvals) and other oncology indications. The first-in-class targets analyzed in this report have shown encouraging efficacy profiles, and some show the ability to chemosensitize cancer cells.

Potential driving factors for the market include a large treatment population, the typically poor outcome, a high chance of recurrence for treated patients, a growing patient pool if disease prognosis can be improved, a lack of targeted therapy options in the market, and the strong understanding of the disease pathophysiology that has developed over the last decade, facilitating the development of novel compounds that may fulfill the unmet needs.

Overall, due to the highly complex and polygenic nature of HNC, which has numerous subtype classifications, it is unlikely that the inhibition of a single target will be sufficient to substantially improve patient prognosis. Instead, it is likely that the concurrent use of multiple targeted therapies alongside other available modes of therapy will improve treatment outcomes.

Scope

  • The report analyzes innovation in HNC in the context of the overall pipeline and current market landscape. It also analyzes the deals landscape surrounding first-in-class products, and pinpoints opportunities for in-licensing.
  • A brief introduction to HNC is provided, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
  • The changing molecular target landscape between the market and the pipeline is reviewed, including particular focal points of innovation in the pipeline.
  • A comprehensive review of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target is included.
  • First-in-class molecular targets are identified and assessed, with a particular focus on early-stage programs for which clinical utility has yet to be evaluated, as well as literature reviews on novel molecular targets.
  • An assessment is made of the licensing and co-development deal landscape for HNC therapies.

Reasons to buy

  • Understand the current clinical and commercial landscape, including a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options.
  • Visualize the composition of the HNC market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge enables a competitive understanding of the gaps in the market.
  • Analyze the HNC pipeline, stratified by stage of development, molecule type and molecular target.
  • Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been further reviewed in greater detail.
  • Identify commercial opportunities in the HNC deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3

2 Executive Summary 4
2.1 High Unmet Need and Limited but Expanding Number of Marketed Options 4
2.2 Large but Highly Innovative Pipeline 4
2.3 Lucrative Deals Landscape, Mostly Involving Currently Established Targets 4

3 The Case for Innovation in the Head and Neck Cancer Market 5
3.1 Growing Opportunities for Biologic Products 5
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Developments Remain Attractive 6
3.4 Sustained Innovation 6
3.5 Report Guidance 7

4 Clinical and Commercial Landscape 8
4.1 Disease Overview 8
4.2 Disease Symptoms 8
4.3 Diagnosis 9
4.4 Etiology 9
4.4.1 Age, Ethnicity and Gender 9
4.4.2 Genetic Factors 10
4.4.3 Smoking, Alcohol and Environmental Factors 10
4.4.4 Viruses 10
4.5 Pathophysiology 11
4.5.1 Tumor Initiation and Aberrant Cell Proliferation and Survival 11
4.5.2 Tumor Metabolic Shift 12
4.5.3 Tumor Progression, Micro-environment Alteration, Angiogenesis and Metastasis 12
4.5.4 Cancer Stem Cells 13
4.6 Epidemiology 14
4.7 Prognosis 15
4.8 Head and Neck Cancer Treatment 15
4.8.1 Surgery and Radiation Therapy 16
4.8.2 Overview of Marketed Products for Head and Neck Cancer 17
4.8.3 Current Unmet Need in the Head and Neck Cancer Market 19

5 Assessment of Pipeline Product Innovation 20
5.1 Head and Neck Cancer Pipeline by Phase, Molecule Type and Molecular Target 20
5.2 First-in-Class Pipeline Programs 24

6 Signaling Network, Disease Causation and Innovation Alignment 32
6.1 The Complexity of Signaling Networks in Oncology 32
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 33
6.3 First-in-Class Target Matrix Assessment 33

7 First-in-Class Target Evaluation 35
7.1 Pipeline Programs Targeting PIK3CA, PIK3CB and PIK3CG 35
7.2 Pipeline Programs Targeting HER3 37
7.3 Pipeline Programs Targeting ADAM17 38
7.4 Pipeline Programs Targeting Protein Kinase C Epsilon Type 39
7.5 Pipeline Programs Targeting AKT1, AKT2 and AKT3 40
7.6 Pipeline Programs Targeting HSP90AA1 42
7.7 Pipeline Programs Targeting Tyrosine-Protein Kinase SYK 43
7.8 Pipeline Programs Targeting Telomerase Reverse Transcriptase 44
7.9 Pipeline Programs Targeting Growth Factor Receptor-Bound Protein 2 46
7.10 Pipeline Programs Targeting Focal Adhesion Kinase 47
7.11 Conclusion 48

8 Deals and Strategic Consolidations 49
8.1 Industry-Wide First-in-Class Deals 49
8.2 Head and Neck Cancer Deals Landscape 50
8.3 Licensing Deals 51
8.3.1 Molecule Type 53
8.3.2 Molecular Target 54
8.4 Co-development Deals 57
8.4.1 Molecule Type 58
8.4.2 Molecular Target 60
8.5 List of Pipeline Products without Prior Licensing or Co-development Deal Involvement 61

9 Appendix 64
9.1 Abbreviations 64
9.2 References 65
9.3 Research Methodology 76
9.4 Secondary Research 76
9.4.1 Market Analysis 77
9.4.2 Pipeline Analysis 77
9.4.3 First-in-Class Matrix Assessment 77
9.4.4 First-in-Class Target Profiles 77
9.4.5 Licensing and Co-development Deals 78
9.5 Contact Us 78
9.6 Disclaimer 78
 

Table 1: Symptoms of Head and Neck Cancer, 2017 8
Table 2: Symptoms of Head and Neck Cancer Metastasis, 2017 9
Table 3: Common Mutations in Head and Neck Cancer Metastasis, 2017 13
Table 4: Head and Neck Cancer, Key Features and Pipeline Activity of PIK3CA, PIK3CB and PIK3CG, 2017 36
Table 5: Head and Neck Cancer, Key Features and Pipeline Activity of HER3, 2017 37
Table 6: Head and Neck Cancers, Key Features and Pipeline Activity of ADAM17, 2017 39
Table 7: Head and Neck Cancer, Key Features and Pipeline Activity of Protein Kinase C Epsilon, 2017 40
Table 8: Head and Neck Cancer, Key Features and Pipeline Activity of AKT1, 2 and 3, 2017 41
Table 9: Head and Neck Cancer, Key Features and Pipeline Activity of HSP90, 2017 43
Table 10: Head and Neck Cancer, Key Features and Pipeline Activity of Tyrosine-Protein Kinase SYK, 2017 44
Table 11: Head and Neck Cancer, Key Features and Pipeline Activity of Telomerase Reverse Transcriptase, 2017 45
Table 12: Head and Neck Cancer, Key Features and Pipeline Activity of Growth Factor Receptor-Bound Protein 2, 2017 46
Table 13: Head and Neck Cancer, Key Features and Pipeline Activity of Focal Adhesion Kinase, 2017 48
Table 14: Abbreviations 64

Figure 1: Pharmaceutical Market, Global, Innovation Trends in Product Approvals, 1987-2016 5
Figure 2: Pharmaceutical Market, Global, Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 6
Figure 3: Head and Neck Cancer, Marketed Product Overview by Molecule Type and Mechanism of Action, 2016 17
Figure 4: Head and Neck Cancer, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area 20
Figure 5: Head and Neck Cancer, Developmental Pipeline Overview, 2017 21
Figure 6: Head and Neck Cancer, Developmental Pipeline by Molecular Target, 2017 23
Figure 7: Head and Neck Cancer, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017 24
Figure 8: Head and Neck Cancer, Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 26
Figure 9: Head and Neck Cancer Drug Market, Global, Percentage Distribution of First-in-Class Products in Pipeline by Stage of Development (%), 2017 27
Figure 10: Head and Neck Cancer Drug Market, Global, Distribution of First-in-Class Products in Pipeline by Molecular Target (%), 2017 27
Figure 11: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 1, 2017 28
Figure 12: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 2, 2017 29
Figure 13: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 3, 2017 30
Figure 14: Head and Neck Cancer, First-in-Class Products in the HNC Pipeline Part 4 2017 31
Figure 15: Head and Neck Cancer, First-in-Class Molecular Target Analysis Matrix, 2017 34
Figure 16: Head and Neck Cancer, Pipeline Programs Targeting PIK3CA/PIK3CB/PIK3CG 36
Figure 17: Head and Neck Cancer, HER3 Targeting Products 38
Figure 18: Head and Neck Cancer, ADAM17 Targeting Products 39
Figure 19: Head and Neck Cancers, Protein Kinase C Epsilon Type Targeting Products 40
Figure 20: Head and Neck Cancer, AKT1/AKT2/AKT3 Targeting Products 42
Figure 21: Head and Neck Cancers, HSP90 Targeting Products 43
Figure 22: Head and Neck Cancer, Tyrosine-Protein Kinase SYK Targeting Products 44
Figure 23: Head and Neck Cancer, Telomerase Reverse Transcriptase Targeting Products 45
Figure 24: Head and Neck Cancer, Growth Factor Receptor-Bound Protein 2 Targeting Products 47
Figure 25: Head and Neck Cancer, Focal Adhesion Kinase 1 Targeting Products 48
Figure 26: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 49
Figure 27: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014 50
Figure 28: Head and Neck Cancer, Global, Licensing Deals by Region and Value, 2006-2016 52
Figure 29: Head and Neck Cancer, Global, Licensing Deals by Stage and Value, 2006-2016 53
Figure 30: Head and Neck Cancer, Licensing Deals by Molecule Type, 2006-2016 54
Figure 31: Head and Neck Cancer, Licensing Deals by Molecular Target, 2006-2016 55
Figure 32: Head and Neck Cancer, Licensing Deals with Disclosed Values, 2006-2016 56
Figure 33: Head and Neck Cancer, Co-development Deals by Region and Value, 2006-2016 57
Figure 34: Head and Neck Cancer, Co-development Deals by Stage and Value, 2006-2016 58
Figure 35: Head and Neck Cancer, Co-development Deals by Molecule Type, 2006-2016 59
Figure 36: Head and Neck Cancer, Co-development Deals by Molecular Target, 2006-2016 60
Figure 37: Head and Neck Cancer, Co-development Deals with Disclosed Values, 2006-2016 61
Figure 38: Head and Neck Cancer, List of Pipeline Products With Prior Licensing or Co-development Deal Involvement, 2016 62
Figure 39: Head and Neck Cancer, List of Pipeline Products Without Prior Licensing or Co-development Deal Involvement, 2016 63