Frontier Pharma: Cancer Immunotherapies – First-in-Class Pipeline Dominated by Immunomodulators and PD-1 Like Targets

Cancer is a group of diseases that are defined by abnormal cell growth, local tissue invasion and eventual migration to other parts of the body. The diseases are driven by the accumulation of genetic mutations, which provide selective advantages to cells allowing them to evolve and propagate virtually all sites and tissues in the human body.

It is now widely believed that tumors are recognized by the immune system, and this tumor-specific immune response is due to the recognition of tumor antigens. However, in many cancers, disease progression is also accompanied by immune suppression, which hinders an effective anti-tumor response and tumor elimination. Over the past few decades cancer immunotherapies have developed into important therapeutic options for some types of cancer.

The different types of cancer immunotherapies used to treat cancer include monoclonal antibodies (mAbs) directed at specific tumor-associated antigens (TAA); immune checkpoint inhibitors, which target key proteins involved in the immune response, such as programmed cell death-1 (PD-1); vaccination of the patient with tumor antigens, and non-specific immunotherapies, such as interferon therapy, which stimulate the immune system in a more generalized manner.

Overall, there are 3,100 products in active development in the cancer immunotherapy pipeline. This makes it a notable portion of the entire oncology pipeline, and reflects the strong interest in this class of therapy in product development. This is due to growing clinical rationale behind developing such therapies, and the willingness of drug developers to invest in novel therapeutics, which will offer significant product differentiation from market competitors.

Scope

– The 3,100 products in active development, of which 989 are first-in-class and therefore act on completely novel targets, far exceed the scope of the current market. How will pipeline innovation affect the future cancer immunotherapies market?

– There are 322 distinct first-in-class molecular targets currently being studied. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?

– Multiple types of cancer immunotherapies exist. Which of these are the most promising, and how does the ratio of first-in-class targets to first-in-class products differ by stage of development and molecular target class?

– A significant number of first-in-class products have been identified with some prior involvement in deals. How do deal frequency and value compare between target families and molecule types, and which first-in-class programs have not yet been involved in a licensing or co-development deal?

Reasons to buy

- Understand the current clinical and commercial landscape. The report includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the treatment options available.

- Visualize the composition of the cancer immunotherapies market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the market.

- Analyze the cancer immunotherapies pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking immunotherapeutic approaches to treating cancer indications with current poor prognoses, including melanoma and lung cancer.

- Assess the therapeutic potential of first-in-class targets. Using a proprietary molecular target matrix tailored directly towards cancer immunotherapies, first-in-class products have been assessed and ranked according to clinical potential.

- Identify commercial opportunities in the cancer immunotherapies deals landscape by analyzing trends in licensing and co-development deals, and producing a list of first-in-class therapies with no prior involvement in licensing or 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 5

2.1 A Large Therapy Area with Varying Unmet Needs across Indications 5

2.2 A Large Pipeline with a High Degree of First-in-Class Innovation 5

3 The Case for Innovation in the Oncology Market 6

3.1 Growing Opportunities for Biologic Products 7

3.2 Diversification of Molecular Targets 7

3.3 Innovative First-in-Class Product Developments Remain Attractive 8

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 8

3.5 Sustained Innovation 9

3.6 Report Guidance 9

4 Clinical and Commercial Landscape 10

4.1 Therapy Area Overview 10

4.1.1 Epidemiology 10

4.1.2 Etiology 14

4.1.3 Pathophysiology 16

4.1.4 Diagnosis 22

4.1.5 Prognosis and Disease Staging 23

4.2 Treatment Options 25

4.2.1 Surgery 25

4.2.2 Radiation Therapy 26

4.2.3 Chemotherapy 27

4.2.4 Hormonal Therapies 28

4.2.5 Targeted Therapies 29

4.2.6 Immunotherapies 30

4.3 Overview of Marketed Products within Cancer Immunotherapy 32

4.4 Current Unmet Needs across the Oncology Markets 34

5 Assessment of Pipeline Product Innovation 36

5.1 Cancer Immunotherapies Pipeline by Phase, Molecule Type and Molecular Target 36

5.2 Comparative Distribution of Programs between the Oncology Market and Pipeline by Therapeutic Target Family 40

5.3 First-in-Class Pipeline Programs 40

5.3.1 First-in-Class Cancer Immunotherapy Products by Phase, Molecule Type and Molecular Target 42

6 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 79

6.1 The Complexity of Signaling Networks in Oncology 79

6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 79

6.3 First-in-Class Target Matrix Assessment 79

7 First-in-Class Target Assessment 84

7.1 Pipeline Programs that Target Low-Affinity Immunoglobulin Gamma Fc Region Receptor IIIA 84

7.2 Pipeline Programs that Target Programmed Death 1 Ligand-2 85

7.3 Pipeline Programs that Target OX-2 Membrane Glycoprotein/CD200 87

7.4 Pipeline Programs that Target Killer-Cell Immunoglobulin-Like Receptors 88

7.5 Pipeline Programs that Target Toll-Like Receptors 89

7.6 Pipeline Programs that Target Inducible T-Cell Costimulator 92

7.7 Pipeline Programs that Target Membrane Cofactor Protein 93

7.8 Pipeline Programs that Target NKG2-A/NKG2-B Type II Integral Membrane Protein 95

7.9 Pipeline Programs that Target Stimulator of Interferon Genes Protein 96

7.10 Conclusion 98

8 Deals and Strategic Consolidations 99

8.1 Licensing Deals 99

8.2 Co-development Deals 105

9 Appendix 121

9.1 Abbreviations 121

9.2 References 122

9.3 Research Methodology 133

9.3.1 Data Integrity 133

9.3.2 Innovative and Meaningful Analytical Technique and Frameworks 134

9.3.3 Evidence-based Analysis and Insight 134

9.4 Secondary Research 134

9.4.1 Market Analysis 134

9.4.2 Pipeline Analysis 134

9.4.3 First-in-Class Matrix Assessment 134

9.4.4 First-in-Class Target Profiles 135

9.4.5 Licensing and Co-Development Deals 135

9.5 Contact Us 135

9.6 Disclaimer 135

List of Tables

1.1 List of Tables

Table 1: Epidemiology by Top 20 Most Common Cancer Sites, 2012 11

Table 2: Epidemiology by Top 20 Most Common Cancer Sites, 2012 12

Table 3: Epidemiology by Top 20 Most Common Cancer Sites, 2012 13

Table 4: Epidemiology by Top 20 Most Common Cancer Sites, 2012 14

Table 5: TNM Staging, 2015 23

Table 6: Karnofsky Scores and Equivalent ECOG Staging, 2015 25

Table 7: Optimal and Actual Radiation Therapy Usage Rates in US, 1995-2000 27

Table 8: Top 10 Cancer Types According to Treatment Demand Criteria, 2017 41

Table 9: Cancer Immunotherapies, Low-Affinity Immunoglobulin Gamma Gc Region Receptor IIIA as a Therapeutic Target, 2017 84

Table 10: Cancer Immunotherapies, Programmed Cell Death 1 Ligand 2 as a Therapeutic Target, 2017 86

Table 11: Cancer Immunotherapies, OX-2 Membrane Glycoprotein/CD200 as a Therapeutic Target, 2017 87

Table 12: Cancer Immunotherapies, Killer-Cell Immunoglobulin-Like Receptors as a Therapeutic Target, 2017 89

Table 13: Cancer Immunotherapies, Toll-Like Receptors as a Therapeutic Target, 2017 90

Table 14: Cancer Immunotherapies, Inducible T-Cell Costimulator as a Therapeutic Target, 2017 93

Table 15: Cancer Immunotherapies, Membrane Cofactor Protein as a Therapeutic Target, 2017 94

Table 16: Cancer Immunotherapies, NKG2-A/NKG2-B Type II Integral Membrane Protein as a Therapeutic Target, 2017 96

Table 17: Cancer Immunotherapies, Stimulator of Interferon Genes Protein as a Therapeutic Target, 2017 97

List of Figures

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals, 1987-2013 7

Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Products Post Marketing Approval, 2006-2013 8

Figure 3: Relative Survival Rates for the Top 20 Cancers by Site, 2014 24

Figure 4: Molecule Types and Molecular Targets of Marketed Products for Oncology, 2017 33

Figure 5: Molecule Types and Molecular Targets of Marketed Products within Cancer Immunotherapies, 2017 34

Figure 6: Summary of Five-Year Survival Rate, Incidence and Mortality by Site, 2012 35

Figure 7: Pipeline Products by Therapy Area, 2017 36

Figure 8: Cancer Immunotherapies Pipeline Products by Stage of Development and Molecule Type, 2017 37

Figure 9: Cancer Immunotherapies Pipeline Products by Stage of Development and Molecular Target, 2017 39

Figure 10: Molecular Target Category Comparison, Pipeline and Marketed Products, 2017 40

Figure 11: Summary of Incidence, Mortality, Mortality Rates and Cancer Immunotherapies Pipeline Activity by Tumor Site, 2015-2017 40

Figure 12: Comparison of First-in-Class to Established Products in the Cancer Immunotherapies Pipeline by Tumor Site, 2017 42

Figure 13: Overview of First-In-Class Cancer Immunotherapies Products, 2017 43

Figure 14: Percentage Distribution of First-in-Class to Established Products, Cancer Immunotherapies Pipeline, 2017 44

Figure 15: Molecular Target Category Comparison, Pipeline First-In-Class and Established Molecular Targets, 2017 45

Figure 16: Cancer Immunotherapies, Ratio of First-in-Class Pipeline Targets to First-in-Class Pipeline Products 46

Figure 17: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 1 47

Figure 18: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 2 48

Figure 19: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 3 49

Figure 20: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 4 50

Figure 21: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 5 51

Figure 22: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 6 52

Figure 23: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 7 53

Figure 24: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 8 54

Figure 25: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 9 55

Figure 26: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 10 56

Figure 27: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 11 57

Figure 28: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 12 58

Figure 29: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 13 59

Figure 30: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 14 60

Figure 31: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 15 61

Figure 32: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 16 62

Figure 33: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 17 63

Figure 34: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 18 64

Figure 35: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 19 65

Figure 36: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 20 66

Figure 37: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 21 67

Figure 38: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 22 68

Figure 39: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 23 69

Figure 40: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 24 70

Figure 41: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 25 71

Figure 42: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 26 72

Figure 43: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 27 73

Figure 44: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 28 74

Figure 45: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 29 75

Figure 46: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 30 76

Figure 47: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 31 77

Figure 48: Cancer Immunotherapies, Global, Pipeline Products, 2017, Part 32 78

Figure 49: Cancer Immunotherapies, Global, First-in-Class Molecular Target Analysis Matrix, 2017, Part 1 80

Figure 50: Cancer Immunotherapies, Global, First-in-Class Molecular Target Analysis Matrix, 2017, Part 2 81

Figure 51: Cancer Immunotherapies, Global, First-in-Class Molecular Target Analysis Matrix, 2017, Part 3 82

Figure 52: Cancer Immunotherapies, Global, First-in-Class Molecular Target Analysis Matrix, 2017, Part 4 83

Figure 53: Pipeline Programs Targeting Low-Affinity Immunoglobulin Gamma Fc Region Receptor IIIA 85

Figure 54: Pipeline Programs Targeting Programmed Cell Death 1 Ligand 2 (PD-L2) 86

Figure 55: Pipeline Programs Targeting OX-2 Membrane Glycoprotein/CD200 88

Figure 56: Pipeline Programs Targeting Killer-Cell Immunoglobulin-Like Receptors 89

Figure 57: Pipeline Programs Targeting Toll-Like Receptor 3 91

Figure 58: Pipeline Programs Targeting Toll-Like Receptor 6 91

Figure 59: Pipeline Programs Targeting Toll-Like Receptor 8 92

Figure 60: Pipeline Programs Targeting Inducible T-Cell Costimulator 93

Figure 61: Pipeline Programs Membrane Cofactor Protein 95

Figure 62: Pipeline Programs Targeting NKG2-A/NKG2-B Type II Integral Membrane Protein 96

Figure 63: Pipeline Programs Targeting Stimulator of Interferon Genes Protein 97

Figure 64: Cancer Immunotherapies, Global, Licensing Deals by Region and Value, 2006-Q1 2017 99

Figure 65: Cancer Immunotherapies, Global, Licensing Deals by Stage and Value, 2006-Q1 2017 100

Figure 66: Cancer Immunotherapies, Global, Licensing Deals by Molecule Type, 2006-Q1 2017 101

Figure 67: Cancer Immunotherapies, Global, Licensing Deals by Molecular Target, 2006-Q1 2017 102

Figure 68: Cancer Immunotherapies, Licensing Deals with Disclosed Values, 2006-Q1 2017, Part 1 103

Figure 69: Cancer Immunotherapies, Licensing Deals with Disclosed Values, 2006-Q1 2017, Part 2 104

Figure 70: Cancer Immunotherapies, Licensing Deals with Disclosed Values, 2006-Q1 2017, Part 3 105

Figure 71: Cancer Immunotherapies, Global, Co-development Deals by Region and Value, 2006-Q1 2017 106

Figure 72: Cancer Immunotherapies, Global, Co-development Deals by Stage and Value, 2006-Q1 2017 107

Figure 73: Cancer Immunotherapies, Global, Co-development Deals by Molecule Type, 2006-Q1 2017 107

Figure 74: Cancer Immunotherapies, Global, Co-development Deals by Molecular Target, 2006-Q1 2017 108

Figure 75: Cancer Immunotherapies, Global, Co-development Deals with Disclosed Values, 2006-Q1 2017 109

Figure 76: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 1 110

Figure 77: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 2 111

Figure 78: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 3 112

Figure 79: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 4 113

Figure 80: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 5 114

Figure 81: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 6 115

Figure 82: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 7 116

Figure 83: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 8 117

Figure 84: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 9 118

Figure 85: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 10 119

Figure 86: Cancer Immunotherapies, Global, First-in-Class Products with No Prior Deal Involvement, 2006-Q1 2017, Part 11 120

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