Frontier Pharma: First-in-Class Innovation in Hematological Cancers – Cytokine Signaling and Kinase Targeted Immunotherapies Dominate a Large and Highly Versatile Pipeline

The American Cancer Society (ACS) predicts that in 2017 there will be almost 173,000 new cases of leukemia, lymphoma and myeloma, with lymphomas the most prevalent. Due to a degree of crossover between hematological malignancies in terms of their underlying pathophysiology, it is not uncommon for products being developed for this therapy area to have developmental programs testing them across multiple indications.

The report assesses versatile and first-in-class innovation in the hematological cancer pipeline, highlighting key trends in first-in-class product distribution. Analysis reveals that the hematological cancer pipeline is among the most innovative in the industry, with 477 first-in-class products.

Over the past 15 years, the treatment of hematological malignancies has changed significantly, thanks to the development of targeted therapies. These developments have been based on the growing understanding of the signaling pathways involved in disease pathogenesis. A notable example is the approval of Rituxan in 1997, which is used to treat multiple types of hematological malignancies, including Non-Hodgkin’s lymphoma. Analysis indicates that the current pipeline is following this trend of focusing on innovative, targeted therapies.

The first-in-class targets in the pipeline are numerous and varied. Cytokine signaling targets are the most common, with a total of 548 across all stages of development, followed by kinases. These target categories account for the majority of targeted immunotherapies, which are the primary focus of current development activity within oncology. The other target families have far fewer first-in-class and versatile first-in-class products, reflecting the strong interest and potential versatility of cancer immunotherapies.

Scope

– With 1,474 products in active development, the pipeline is considerably large. How will pipeline innovation affect the future hematological cancer market?

– There are 477 first-in-class products in the hematological cancer pipeline. Which of these hold the greatest potential to improve future disease treatment with regard to their molecular target?

– The majority of first-in-class products were identified to be in development for multiple indications. Are versatile products likely to play a key role in the future treatment of hematological cancer?

– Analysis of the history of strategic consolidations revealed an increasing amount of deal activity and a large number of first-in-class products not yet involved in any 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. This includes a comprehensive study of disease pathogenesis, diagnosis and prognosis, and the treatment options available.

- Visualize the composition of the hematological cancers 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 current market.

- Analyze the hematological cancers pipeline and stratify by stage of development, molecule type and molecular target. There are strong signs in the pipeline that the industry is seeking novel approaches to treating hematological cancers.

- 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 reviewed in greater detail.

- Understand the level of versatility across the pipeline and within each molecular target. Assess the pipeline activity of each versatile first-in-class product and the indications that they are being developed for.

- Identify commercial opportunities in the hematological cancers deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of hematological cancer therapies that have not yet been involved in deals, and may offer potential investment opportunities.

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 Large Therapy Area with a High Degree of Pathophysiological Crossover 5

2.2 High Degree of First-in-Class Programs and Program Versatility in a Strong Pipeline 5

2.3 Sharp Increase in Deal Activity in Recent Years 5

3 The Case for Innovation in the Hematological Cancer Market 6

3.1 Growing Number of 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 GBI Research Report Guidance 9

4 Clinical and Commercial Landscape 10

4.1 Disease Overview 10

4.2 Symptoms 10

4.3 Diagnosis 10

4.3.1 Leukemia 10

4.3.2 Lymphoma 11

4.3.3 Myeloma 12

4.4 Etiology 12

4.4.1 Leukemia 12

4.4.2 Lymphoma 12

4.4.3 Myeloma 12

4.5 Pathophysiology 13

4.5.1 Leukemia 13

4.5.2 Lymphoma 14

4.5.3 Myeloma 16

4.6 Epidemiology 17

4.6.1 Leukemia 17

4.6.2 Lymphoma 18

4.6.3 Myeloma 18

4.7 Treatment 18

4.7.1 Surgery and Radiation Therapy 19

4.7.2 Stem-Cell Transplantation 19

4.7.3 Pharmacotherapy 20

4.8 Overview of Marketed Products 21

4.9 Current Unmet Need in the Hematological Cancer Market 22

5 Pipeline Landscape Assessment 24

5.1 Hematological Cancers Pipeline Overview 24

5.1.1 Pipeline Development Landscape 24

5.1.2 Molecular Targets in the Pipeline 25

5.1.3 Comparative Distribution of Programs between the Hematological Cancer Market and Pipeline by Molecular Target 26

5.2 First-in-Class and Versatile Programs 26

5.2.1 First-in-Class Hematological Cancers Programs by Phase, Molecule Type and Molecular Target 26

5.2.2 Versatility of First-in-Class Pipeline Programs 30

6 Signaling Network and Innovation Alignment within Hematological Cancers 39

6.1 Complexity of Signaling Networks in Hematological cancer 39

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 39

6.3 First-in-Class Matrix Assessment 40

7 First-in-Class Target Evaluation 45

7.1 Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein 1 45

7.1.1 Overview of Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein 1 46

7.2 Pipeline Programs Targeting Inactive Tyrosine Protein Kinase Transmembrane Receptor ROR-1 46

7.2.1 Overview of Pipeline Programs Targeting Inactive Tyrosine Protein Kinase Transmembrane Receptor ROR-1 47

7.3 Pipeline Programs Targeting Aurora kinase-A and -B 48

7.3.1 Overview of Pipeline Programs Targeting Aurora Kinase-A and -B 49

7.4 Pipeline Programs Targeting TNF Receptor Superfamily Member-6 50

7.4.1 Overview of Pipeline Programs Targeting TNF Receptor Superfamily Member-6 51

7.5 Pipeline Programs Targeting Leukocyte Surface Antigen CD47 51

7.5.1 Overview of Pipeline Programs Targeting Leukocyte Surface Antigen CD47 52

7.6 Pipeline Programs Targeting e3 Ubiquitin Protein Ligase MDM-2 53

7.6.1 Overview of Pipeline Programs Targeting e3 Ubiquitin Protein Ligase MDM2 54

7.7 Pipeline Programs Targeting Transforming Growth Factor-Beta Receptor Type-1 55

7.7.1 Overview of Pipeline Programs Targeting Transforming Growth Factor-Beta Receptor Type-1 56

7.8 Pipeline Programs Targeting Spleen Tyrosine Kinase 57

7.8.1 Overview of Pipeline Programs Targeting Spleen Tyrosine Kinase 58

7.9 Conclusion 59

8 Deals and Strategic Consolidations 60

8.1 Industry-Wide First-in-Class Deals 60

8.2 Hematological Cancer Deals Landscape 61

8.3 Licensing Deals 61

8.3.1 Deals by Region, Year and Value 61

8.3.2 Deals by Stage of Development and Value 62

8.3.3 Molecule Type and Value 63

8.3.4 Molecular Target and Value 63

8.4 Co-development Deals 66

8.4.1 Deals by Region, Year and Value 66

8.4.2 Deals by Stage of Development and Value 67

8.4.3 Molecule Type and Value 67

8.4.4 Molecular Target and Value 67

8.5 List of First-in-Class Pipeline Programs with and without Prior Deal Involvement 69

9 Appendix 77

9.1 Abbreviations 77

9.2 References 78

9.3 Research Methdology 82

9.3.1 Data integrity: 82

9.3.2 Innovative and meaningful analytical techniques and frameworks: 82

9.3.3 Evidence based analysis and insight: 83

9.4 Secondary Research 83

9.4.1 Market Analysis 83

9.4.2 Pipeline Analysis 83

9.5 Contact Us 84

9.6 Disclaimer 84

List of Tables

1.1 List of Tables

Table 1: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Epidemiology of Hematological Disease Severity, Forecast 2017 17

Table 2: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Commonly Used Chemotherapy Regimens, 2017 20

Table 3: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Receptor Neurogenic Locus Notch Homolog Protein 1 as a Molecular Target, 2017 46

Table 4: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Inactive Tyrosine Protein Kinase Transmembrane Receptor ROR-1 as a Molecular Target, 2017 47

Table 5: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Aurora Kinase-A and -B as a Molecular Target, 2017 49

Table 6: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for TNF Receptor Superfamily Member-6 as a Molecular Target, 2017 51

Table 7: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Leukocyte Surface Antigen CD47 as a Molecular Target, 2017 52

Table 8: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Molecular Target e3 Ubiquitin Protein Ligase MDM2, 2017 54

Table 9: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Transforming Growth Factor-Beta Receptor Type-1 as a Molecular Target, 2017 56

Table 10: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Data for Spleen Tyrosine Kinase as a Molecular Target, 2017 58

List of Figures

1.2 List of Figures

Figure 1: Overall Pharmaceutical Industry, Innovation Trends in Product Approvals, Number of Product Approvals by FDA and Five-Year Moving Average of Products Approvals (%), 1987–2015 7

Figure 2: Versatile Innovation in Hematological Cancers Therapeutics Market, First-in-Class and Non-First-in-Class Products, Sales Performance After Marketing Approval, 2006–2013 ($m) 8

Figure 3: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Marketed Product Overview, 2017 22

Figure 4: Pharmaceutical Market, Global, Developmental Pipeline Overview, 2017 24

Figure 5: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline by Stage of Development and Molecule Type, 2017 25

Figure 6: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline by Molecular Target, 2017 26

Figure 7: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Molecular Target Category Comparison, Pipeline and Marketed Products, 2017 26

Figure 8: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline for Hematological Cancers by Stage of Development and Molecule Type, 2017 27

Figure 9: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline by Molecular Target, 2017 28

Figure 10: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Molecular Target Family Comparison, Pipeline First-in-Class and Established Molecular Targets, 2017 29

Figure 11: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Percentage of First-in-Class Products in Pipeline by Stage of Development (%), 2017 30

Figure 12: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Percentage of First-in-Class Programs in Pipeline by Molecular Target (%), 2017 30

Figure 13: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Hematological Cancers Pipeline Products by Number of Indications, 2017 31

Figure 14: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Versatile Pipeline for Hematological Cancers by Stage of Development and Molecule Type, 2017 32

Figure 15: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Versatile Pipeline for Hematological Cancers by Molecular Target, 2017 33

Figure 16: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline for Hematological Cancers by Versatile Status and Molecular Target Class, 2017 34

Figure 17: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline for Hematological Cancers Indications, 2017 (Part – 1) 35

Figure 18: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline for Hematological Cancers Indications, 2017 (Part – 2) 36

Figure 19: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline for Hematological Cancers Indications, 2017 (Part – 3) 37

Figure 20: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Pipeline for Hematological Cancers Indications, 2017(Part – 4) 38

Figure 21: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, 2017 41

Figure 22: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, 2017 42

Figure 23: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, 2017 43

Figure 24: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Molecular Target Analysis Matrix, 2017 44

Figure 25: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Neurogenic Locus Notch Homolog Protein 1, 2017 46

Figure 26: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Inactive Tyrosine Protein Kinase Transmembrane Receptor ROR-1, 2017 48

Figure 27: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Aurora Kinase-A and -B, 2017 50

Figure 28: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting TNF Receptor Superfamily Member-6, 2017 51

Figure 29: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Leukocyte Surface Antigen CD47, 2017 53

Figure 30: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting e3 Ubiquitin Protein Ligase MDM2, 2017 55

Figure 31: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Transforming Growth Factor-Beta Receptor Type-1, 2017 57

Figure 32: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Pipeline Programs Targeting Spleen Tyrosine Kinase, 2017 58

Figure 33: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006–2014 60

Figure 34: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006–2014 61

Figure 35: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Licensing Deals by Region and Value, 2006–2017 62

Figure 36: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Licensing Deals by Stage of Development, 2006–2017 63

Figure 37: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Licensing Deals by Molecule Type, 2006–2017 63

Figure 38: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Licensing Deals by Molecular Target, 2006–2017 64

Figure 39: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006–2017 65

Figure 40: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Co-development Deals by Region and Value, 2006–2017 66

Figure 41: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006–2017 67

Figure 42: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Co-development Deals by Molecule Type, 2006–2017 67

Figure 43: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006–2017 68

Figure 44: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, Co-development Deals Valued Above $100m, 2006–2017 69

Figure 45: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Involved in Previous Deals, 2017 (Part – 1) 70

Figure 46: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Involved in Previous Deals, 2017 (Part – 2) 71

Figure 47: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Involved in Previous Deals, 2017 (Part – 3) 72

Figure 48: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Without Recorded Prior Deal Involvement, 2017(Part – 1) 73

Figure 49: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Without Recorded Prior Deal Involvement, 2017(Part – 2) 74

Figure 50: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Without Recorded Prior Deal Involvement, 2017(Part – 3) 75

Figure 51: Versatile Innovation in Hematological Cancers Therapeutics Market, Global, First-in-Class Programs in Active Development Without Recorded Prior Deal Involvement, 2017(Part – 4) 76

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