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

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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.

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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.

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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 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

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