Frontier Pharma: Glioblastoma Multiforme - Cancer Immunotherapies Dominate First-in-Class Product Innovation

Publisher Name :
Date: 01-Sep-2016
No. of pages: 73

Glioblastoma multiforme (GBM) is the most common and aggressive type of human brain tumor, accounting for 15.4% of all primary brain tumors. GBM constitutes 60–75% of all astrocytomas – a cancer of the brain originating in a particular type of glial cell in the cerebrum called astrocytes (NCI, 2013a; ABTA, 2016a). It is most common in the elderly, with a peak incidence rate between the ages of 55 and 84, and a median age of diagnosis of 64 (Nelson et al., 2012; Thakkar et al., 2014).

Glioblastoma multiforme (GBM) has a low incidence and prevalence population in the US and EU, with the annual incidence estimated to be three to four cases per 100,000 people. There is a poor prognosis associated with the current standard of care, which is surgical resection followed by radiation therapy and temozolomide chemotherapy, with an associated median survival duration of 12–14 months (Johnson and O’Neill, 2011). There is a limited number of approved drugs for GBM, and these are subject to regional variations. Gliadel and temozolomide are the most widely approved globally, and are cytotoxic chemotherapies that are associated with more toxicity than targeted treatments.

The GBM cancer pipeline is moderately sized, with 512 products active across all stages of development. The range of mechanisms of action employed by these compounds is also highly diverse, especially in comparison with the existing market landscape. More pertinently, there is a large proportion of breakthrough innovations in this pipeline.
It is identified that 120 first-in-class programs in the GBM pipeline, acting on 86 first-in-class molecular targets. This accounts for 31% of all products with a disclosed molecular target, and reflects the high degree of innovation in this indication.

The report “Frontier Pharma: Glioblastoma Multiforme - Cancer Immunotherapies Dominate First-in-Class Product Innovation” analyzes innovation in GBM, in the context of the overall pipeline and current market landscape. In addition, it analyzes the deals landscape surrounding first-in-class products, and pinpoints opportunities for in-licensing.

In particular, this report includes analysis of the following:
• Provides a brief introduction to GBM, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms
• Provides comprehensive analysis of the pipeline for first-in-class therapies, analyzed on the basis of stage of development, molecule type and molecular target.
• This report help to Identify and assessment of first-in-class molecular targets, 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.

Frontier Pharma: Glioblastoma Multiforme - Cancer Immunotherapies Dominate First-in-Class Product Innovation

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 Low Prevalence but a High Unmet Need and a Limited Number of Marketed Options 4
2.2 Moderately Sized but Innovative Pipeline 4
2.3 Moderately Active Deals Landscape, Mostly Involving Currently Established Targets 4

3 The Case for Innovation in the Glioblastoma Multiforme 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 Changes in Clinical and Commercial Environment to be More Favorable to Products Targeting Niche Patient Populations and Indications 6
3.5 Sustained Innovation 7
3.6 Report Guidance 7

4 Clinical and Commercial Landscape 8
4.1 Disease Overview 8
4.2 Epidemiology 8
4.3 Disease Symptoms 8
4.4 Etiology 9
4.4.1 Age, Rae and Gender 9
4.4.2 Genetic Factors 10
4.4.3 Environmental Factors 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 and Angiogenesis 12
4.5.4 Cancer Stem Cells 13
4.6 Diagnosis 14
4.7 GBM Prognosis and Prognostic Factors 15
4.8 Classification 15
4.8.1 Loss of Heterozygosity of Chromosome 10 16
4.8.2 Epidermal Growth Factor Receptor Amplification 17
4.8.3 Phosphatase and Tensin Homolog Mutation 17
4.8.4 Loss of p53 Function 17
4.8.5 p16INK4a Alteration and Loss of Normal Retinoblastoma 1 Function 17
4.8.6 Isocitrate Dehydrogenase 1 or Isocitrate Dehydrogenase 2 Mutation 18
4.9 Glioblastoma Multiforme Treatment 18
4.10 Surgery and Radiation Therapy 18
4.11 Overview of Marketed Products for Glioblastoma Multiforme 19
4.11.1 Chemotherapy 20
4.11.2 Targeted Therapies 21
4.12 Treatment Algorithm 21
4.13 Current Unmet Need in the GBM Market 23

5 Assessment of Pipeline Product Innovation 24
5.1 Glioblastoma Pipeline by Phase, Molecule Type and Molecular Target 24
5.2 First-in-Class Pipeline Programs 28

6 Signaling Network, Disease Causation and Innovation Alignment 33
6.1 The Complexity of Signaling Networks in Oncology 33
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 34
6.3 First-in-Class Target Matrix Assessment 34

7 First-in-Class Target Evaluation 36
7.1 Pipeline Programs Targeting AKT 1 and 2 36
7.2 Pipeline Programs Targeting CDK1/2 37
7.3 Pipeline Programs Targeting PIK3CB and PIK3CG 38
7.4 Pipeline Programs which Target NTRK1 39
7.5 Pipeline Programs Targeting XIAP 41
7.6 Pipeline Programs Targeting Myc 42
7.7 Pipeline Programs Targeting PRKCA 43
7.8 Pipeline Programs which Target CASP8 and CASP9 44
7.9 Pipeline Programs which Target NR4A1 45
7.10 Pipeline Programs Targeting HIF-1α 45
7.11 Conclusion 47

8 Deals and Strategic Consolidations 48
8.1 Industry-Wide First-in-Class Deals 48
8.2 Glioblastoma Multiforme Deals Landscape 49
8.3 Licensing Deals 50
8.3.1 Molecule Type 52
8.3.2 Molecular Target 52
8.4 Co-development Deals 53
8.4.1 Molecule Type 55
8.4.2 Molecular Target 55
8.5 List of Pipeline Products without Prior Licensing or Co-Development Deal Involvement 57

9 Appendix 59
9.1 Abbreviations 59
9.2 References 60
9.3 Research Methodology 71
9.4 Secondary Research 71
9.4.1 Market Analysis 71
9.4.2 Pipeline Analysis 71
9.4.3 First-in-Class Matrix Assessment 72
9.4.4 First-in-Class Target Profiles 72
9.4.5 Licensing and Co-Development Deals 72
9.5 Contact Us 73
9.6 Disclaimer 73

List of Tables

Table 1: Symptoms of Glioblastoma, 2016 9
Table 2: Glioblastoma Multiforme, Histopathological and Genetic Subtypes 16
Table 3: Glioblastoma Multiforme, Key Features and Pipeline Activity of AKT1 and 2, 2016 37
Table 4: Glioblastoma Multiforme, Key Features and Pipeline Activity of CDK1/2, 2016 38
Table 5: Glioblastoma Multiforme, Key Features and Pipeline Activity of PIK3CB and PIK3CG, 2016 39
Table 6: Glioblastoma Multiforme, Key Features and Pipeline Activity of NTRK1, 2016 41
Table 7: Glioblastoma Multiforme, Key Features and Pipeline Activity of XIAP, 2016 42
Table 8: Glioblastoma Multiforme, Key Features and Pipeline Activity of Myc, 2016 42
Table 9: Glioblastoma Multiforme, Key Features and Pipeline Activity of PRKCA, 2016 43
Table 10: Glioblastoma Multiforme, Key Features and Pipeline Activity of CASP8 and 9, 2016 44
Table 11: Glioblastoma Multiforme, Key Features and Pipeline Activity of NR4A1, 2016 45
Table 12: Glioblastoma Multiforme, Key Features and Pipeline Activity of HIF-1α, 2016 46
Table 13: Abbreviations 59

List of Figures

Figure 1: Pharmaceutical Market, Global, Innovation Trends in Product Approvals, 1987-2012 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: Glioblastoma Multiforme, Genetic Pathways to Primary and Secondary Glioblastoma Multiforme and the Incidence of Mutations 16
Figure 4: Glioblastoma Multiforme, Marketed Product Overview, 2016 20
Figure 5: Glioblastoma Multiforme, Treatment Algorithm Overview 22
Figure 6: Glioblastoma Multiforme, Developmental Pipeline Overview, 2016 25
Figure 7: Glioblastoma Multiforme, Developmental Pipeline by Molecular Target, 2016 27
Figure 8: Glioblastoma Multiforme, Molecular Target Category Comparison, Pipeline and Marketed Products, 2016 28
Figure 9: Glioblastoma Multiforme, Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 30
Figure 10: Glioblastoma Multiforme, First-in-Class Products in the GBM Pipeline Part 1, 2016 31
Figure 11: Glioblastoma Multiforme, First-in-Class Products in the GBM Pipeline Part 2, 2016 32
Figure 12: Glioblastoma Multiforme, First-in-Class Molecular Target Analysis Matrix, 2016 35
Figure 13: Glioblastoma Multiforme, Pipeline Programs Targeting AKT1 and 2, 2016 37
Figure 14: Glioblastoma Multiforme, CDK1/2 Targeting Products, 2016 38
Figure 15: Glioblastoma Multiforme, PIK3CB/PIK3CG Targeting Products, 2016 39
Figure 16: Glioblastoma Multiforme, NTRK1 Targeting Products, 2016 41
Figure 17: Glioblastoma Multiforme, XIAP Targeting Products, 2016 42
Figure 18: Glioblastoma Multiforme, Myc Targeting Products, 2016 43
Figure 19: Glioblastoma Multiforme, PRKCA Targeting Products, 2016 43
Figure 20: Glioblastoma Multiforme, CASP8 and 9 Targeting Products, 2016 45
Figure 21: Glioblastoma Multiforme, NR4A1 Targeting Products, 2016 45
Figure 22: Glioblastoma Multiforme, HIF-1α Targeting Products, 2016 46
Figure 23: Pharmaceutical Market, Global, Industry-Wide Deals by Stage of Development, 2006-2014 48
Figure 24: Pharmaceutical Market, Global, Industry Licensing Deal Values by Stage of Development, 2006-2014 49
Figure 25: Glioblastoma Multiforme, Global, Licensing Deals by Region and Value, 2006-2015 51
Figure 26: Glioblastoma Multiforme, Global, Licensing Deals by Stage and Value, 2006-2016 52
Figure 27: Glioblastoma Multiforme, Licensing Deals by Molecule Type, 2006-2016 52
Figure 28: Glioblastoma Multiforme, Licensing Deals by Molecular Target, 2006-2016 53
Figure 29: Glioblastoma Multiforme, Licensing Deals with Disclosed Values, 2006-2016 53
Figure 30: Glioblastoma Multiforme, Co-development Deals by Region and Value, 2006-2016 54
Figure 31: Glioblastoma Multiforme, Co-development Deals by Stage and Value, 2006-2016 55
Figure 32: Glioblastoma Multiforme, Co-development Deals by Molecule Type, 2006-2016 55
Figure 33: Glioblastoma Multiforme, Co-Development Deals by Molecular Target, 2006-2016 56
Figure 34: Glioblastoma Multiforme, Co-Development Deals with Disclosed Values, 2006-2016 56
Figure 35: Glioblastoma Multiforme, List of Pipeline Products With Prior Licensing or Co-Development Deal Involvement, 2016 57
Figure 36: Glioblastoma Multiforme, List of Pipeline Products Without Prior Licensing or Co-Development Deal Involvement, 2016 58

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