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Frontier Pharma: Gastric Cancer - Early Stage Pipeline Innovation Shows Shift Towards Targeted mAbs

Published: Mar 29, 2016 | Pages: 70 | Publisher: GBI Research | Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)

Frontier Pharma: Gastric Cancer - Early Stage Pipeline Innovation Shows Shift Towards Targeted mAbs

Summary

Gastric cancer is the fifth most common cancer globally, and due to its indolent nature remains one of the most common causes of cancer-related death worldwide. Such a poor outlook, particularly for patients with advanced disease, has created a pressing need for improved therapeutic options. The gastric cancer market is undergoing a gradual change, from a focus on generic chemotherapy regimens to complex treatment landscape based on targeted therapies. Recently the market has witnessed the approval of efficacious therapies such as Cyramza, but this only benefits a small subset of patients. As the understanding of disease pathophysiology increases, new targets need to be identified and converted into improved therapeutic options. The current pipeline shows strong promise, as it shows a gradual shift from generic cytotoxic therapies to more diverse targeted therapies.

Scope

- What is the pathophysiology of gastric cancer?
- How is gastric cancer diagnosed?
- What are the current treatment options?
- What are the common targets and mechanisms of action of pipeline therapies?
- Will the pipeline address unmet needs such as a lack of diverse treatment options for gastric cancer patients?
- What implications will the increased focus on targeted therapies have on the future of gastric cancer treatment?
- What are the most promising first-in-class targets for gastric cancer?
- Will the current first-in-class targets have a broader therapeutic potential across the industry?
- How do deal frequency and value compare between target families and molecule types?
- How do licensing and co-development deals compare between first-in-class and non-first-in-class profiles?

Reasons to buy

- Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies
- Visualize the composition of the gastric cancer market in terms of dominant therapies for each patient subset along with their clinical and commercial standing. Unmet needs in the current market are highlighted to allow a competitive understanding of gaps in the current market.
- Analyze the gastric cancer pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches to treating gastric cancer.
- 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 gastric cancer deals landscape by analyzing trends in licensing and co-development deals and producing a list of gastric cancer therapies that are not yet involved in deals, and may be potential investment opportunities.
 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 Significant Unmet Needs in the Gastric Cancer Market 4
2.2 High Proportion of First-in-Class Innovation Offers Promise in Gastric Cancer 4
2.3 Deal Activity Varies with First-in-Class Status 4

3 The Case for Innovation 5
3.1 Growing Opportunities for Biologic Products 6
3.2 Diversification of Molecular Targets 6
3.3 Innovative First-in-Class Product Development Remains Attractive 6
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7
3.5 Sustained Innovation 7
3.6 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9
4.1 Disease Overview 9
4.2 Disease Symptoms 9
4.3 Epidemiology and Etiology 9
4.4 Pathophysiology 9
4.4.1 Helicobacter Pylori 10
4.4.2 Oncogenes 10
4.4.3 Tumor Suppressor Genes 10
4.4.4 Cell Adhesion Molecules and Metastasis-Related Genes 10
4.4.5 Cell Cycle Regulators 10
4.4.6 Microsatellite and Chromosomal Instability 10
4.4.7 Growth Factor and Cytokines 11
4.5 Diagnosis and Staging 11
4.6 Classification 12
4.6.1 Intestinal Subtype 12
4.6.2 Diffuse Subtype 12
4.7 Prognosis 12
4.8 Treatment Options 13
4.8.1 Surgery 13
4.8.2 First-Line Therapy 13
4.8.3 Second-Line Therapy 16
4.9 Overview of Marketed Products in Gastric Cancer 17
4.9.1 Molecule Type and Target Analysis 17
4.9.2 Innovative Products in Gastric Cancer Market 19
4.9.3 Unmet Needs 19

5 Assessment of Pipeline Product Innovation 20
5.1 Gastric Cancer Pipeline by Molecule Type, Phase and Therapeutic Target 20
5.2 Comparative Distribution of Programs between the Gastric Cancer Market and Pipeline by Therapeutic Target Family 24
5.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 24

6 Signaling Network, Disease Causation and Innovation Alignment 31
6.1 Complexity of Signaling Networks in Oncology 31
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 32
6.3 First-in-Class Matrix Assessment 32

7 First-in-Class Target Evaluation 35
7.1 Pipeline Programs Targeting HER 3 35
7.2 Pipeline Programs Targeting Ataxia Telangiectasia Mutated 37
7.3 Pipeline Programs Targeting L1 Cell Adhesion Molecule 38
7.4 Pipeline Programs Targeting Akt 1, 2 and 3 40
7.5 Pipeline Programs Targeting Fibroblast Growth Factor receptor 3 44
7.6 Pipeline Programs Targeting 3-Phosphoinositide-Dependent Protein Kinase 1 46
7.7 Conclusion 47

8 Deals and Strategic Consolidation 48
8.1 Industry-Wide First-in-Class Deals 48
8.2 Licensing Deals 49
8.2.1 Licensing Deals by Molecule Type 51
8.2.2 Licensing Deals by Molecular Target 52
8.2.3 Conclusion 53
8.3 Co-development Deals 54
8.3.1 Co-development Deals by Molecule Type 57
8.3.2 Co-development Deals by Molecular Target 57
8.3.3 Conclusion 58
8.4 First-in-Class Programs Not Involved in Licensing or Co-development Deals 59

9 Appendix 62
9.1 References 62
9.2 Abbreviations 66
9.3 Research Methodology 68
9.4 Secondary Research 69
9.4.1 Marketed Product Heatmaps and Treatment Algorithm 69
9.4.2 Pipeline Analysis 69
9.4.3 First-in-Class Matrix Assessment 69
9.4.4 First-in-Class Target Profiles 70
9.4.5 Licensing and Co-Development Deals 70
9.5 Contact Us 70
9.6 Disclaimer 70
List of Tables

Table 1: Gastric Cancer, Tumor, Node and Metastasis Staging 12
Table 2: Gastric Cancer, Key Features and Pipeline Activity of HER 3 36
Table 3: Gastric Cancer, Key Features and Pipeline Activity of ATM 38
Table 4: Gastric Cancer, Key Features and Pipeline Activity of L1CAM 39
Table 5: Frequency of Mutations in Components in Akt Proteins, by Cancer Type 41
Table 6: Gastric Cancer, Key Features and Pipeline Activity of AKT 1 42
Table 7: Gastric Cancer, Key Features and Pipeline Activity of AKT 2 42
Table 8: Gastric Cancer, Key Features and Pipeline Activity of AKT 3 43
Table 9: Gastric Cancer, Key Features and Pipeline Activity of FGFR-3 45
Table 10: Gastric Cancer, Key Features and Pipeline Activity of PDPK1 46
Table 11: List of Abbreviations 66 


List of Figures

Figure 1: Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987–2012 5
Figure 2: First-in-Class and Non-First-in-Class Products, Sales Performance After Marketing Approval ($m) 7
Figure 3: Gastric Cancer, Heatmap for First-Line Marketed Products 15
Figure 4: Gastric Cancer, Heatmap for Second-Line Therapy Marketed Products 17
Figure 5: Gastric Cancer, Overview of Marketed Products 18
Figure 6: Gastric Cancer , Overview of Pipeline Products 21
Figure 7: Gastric Cancer, Molecular Targets in Pipeline 23
Figure 8: Gastric Cancer, Pipeline by Molecular Targets and Stage of Development 24
Figure 9: Gastric Cancer, Molecular Target Family Comparison, Pipeline and Marketed Products 24
Figure 10: Gastric Cancer, Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets 26
Figure 11: Gastric Cancer, Percentage of First-in-Class Products in Pipeline by Molecular Target Family (%) 27
Figure 12: Gastric Cancer, Percentage of First-in-Class Products in Pipeline by Stage of Development (%) 27
Figure 13: Gastric Cancer, First-in-Class Products in Pipeline (Part 1) 28
Figure 14: Gastric Cancer, First-in-Class Products in Pipeline (Part 2) 29
Figure 15: Gastric Cancer, First-in-Class Products in Pipeline (Part 3) 30
Figure 16: Gastric Cancer, Target Matrix Assessment (Part 1) 33
Figure 17: Gastric Cancer, Target Matrix Assessment (Part 2) 34
Figure 18: Gastric Cancer, Programs Targeting HER 3 36
Figure 19: Gastric Cancer, Programs Targeting ATM 38
Figure 20: Gastric Cancer, Programs Targeting L1CAM 39
Figure 21: Gastric Cancer, Programs Targeting AKT 1 43
Figure 22: Gastric Cancer, Programs Targeting AKT 2 43
Figure 23: Gastric Cancer, Programs Targeting AKT 3 43
Figure 24: Gastric Cancer, Programs Targeting FGFR 3 46
Figure 25: Gastric Cancer, Programs Targeting PDPK1 46
Figure 26: Gastric Cancer, Deals by Stage of Development, 2006–2014 48
Figure 27: Gastric Cancer, Licensing Deal Values by Stage of Development ($m), 2006–2014 49
Figure 28: Gastric Cancer, Licensing Deal Value, 2006–2015 50
Figure 29:Gastric Cancer, Licensing Deals by Year, 2006–2015 50
Figure 30: Gastric Cancer, Licensing Deals by Stage of Development, 2006–2015 51
Figure 31: Gastric Cancer, Licensing Deal Value by Stage of Development and Molecule Type, 2006–2015 52
Figure 32: Gastric Cancer, Licensing Deal Value by Molecular Target, 2006–2015 53
Figure 33: Gastric Cancer, Summary of Licensing Deals, 2006–2015 54
Figure 34: Gastric Cancer, Co-development Deal Value, 2006–2015 55
Figure 35: Gastric Cancer, Co-development Deals by Year, 2006–2015 55
Figure 36: Gastric Cancer, Co-development Deals by Stage of Development, 2006–2015 56
Figure 37: Gastric Cancer, Co-development by Stage of Development and Molecule Type, 2006–2015 57
Figure 38: Gastric Cancer, Co-development by Stage of Development and Molecular Target, 2006–2015 58
Figure 39: Gastric Cancer, Summary of Co-development Deals, 2006–2015 59
Figure 40: Gastric Cancer, First-in-Class Therapies Not Involved in Deals (Part 1) 60
Figure 41: Gastric Cancer, First-in-Class Therapies Not Involved in Deals (Part 2) 61

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