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

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

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

Summary

Glioblastoma multiforme (GBM) is a grade IV tumor that arises from astrocytes. It is the most common and aggressive human brain tumor, accounting for 15.4% of all primary brain tumors and 60-75% of all astrocytomas. It has a peak incidence between 55 and 84 years of age, with the median age of diagnosis being 64 years. In the US and EU, the annual incidence was estimated to be three to four cases per 100,000 people. GBM has a high degree of intratumoral heterogeneity, which is associated with poor prognosis and the development of drug resistance.

The GBM 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 large, with 512 products active across all stages of development. First-in-class products only constitute approximately a quarter of the pipeline, and represent 31% of products with a disclosed target. The most widely studied group of first-in-class targets are the receptor tyrosine kinase and ligand inhibitors, a trend that has been heavily influenced by the success of Avastin, and possibly successful EGFR inhibitors such as Tarceva that are used in the treatment of other oncology indications.

Potential driving factors for the market include a typically poor outcome for treated patients, a growing patient pool if disease prognosis can be improved, a lack of approved options in the market, and a 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 GBM, 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 more likely that the concurrent use of multiple targeted therapies, along with other available modes of therapy, may improve treatment outcomes. First-in-class targets analyzed in this report have shown encouraging efficacy profiles, and some show the ability to chemosensitize cancer cells.

Scope

- The report 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.
- A brief introduction to GBM, including symptoms, pathophysiology, and an overview of pharmacotherapy and treatment algorithms.
- The changing molecular target landscape between the market and the pipeline, 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.
- Identification 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.
- Assessment of the licensing and co-development deal landscape for GBM 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 GBM 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 the gaps in the current market.
- Analyze the GBM 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 GBM deals landscape by analyzing trends in licensing and co-development deals.
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 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-1? 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-1?, 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-1? 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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