Frontier Pharma: Breast Cancer-First-in-Class Innovation Underlies Immunotherapeutic Potential and Pipeline Diversification for Late-Stage Breast Cancer

Frontier Pharma: Breast Cancer-First-in-Class Innovation Underlies Immunotherapeutic Potential and Pipeline Diversification for Late-Stage Breast Cancer

Summary

Breast cancer remains a major global healthcare concern despite exceptional levels of public awareness about the disease. A lack of clear causative environmental factors and hereditary dispositioning have resulted in the incidence of breast cancer continuing to rise, a trend which is expected to continue into the immediate future.

In the UK, breast cancer is the leading type of cancer in women, with there being over 54,900 cases diagnosed each year. Although early-stage cancer is relatively treatable and has good 5-and 10-year disease-free survival rates, 10% of cancers are diagnosed late. Additionally, there are no treatments for metastatic breast cancer, which ultimately results in death.

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As a whole, this presents a huge unmet clinical need in the breast cancer treatment algorithm. The treatment algorithm for breast cancer focuses on two main themes: standard chemotherapy and drugs that target hormones, namely estrogen and progesterone. However, chemotherapy and hormone drugs only make up a small percentage of the drug pipeline and an even smaller percentage of first-in-class products.

New trends in oncology are present in the breast cancer pipeline, in particular the focus on extracellular matrix degradation and improving the immune response to tumors. This report focuses on the epidemiology, pathophysiology and existing treatment options for breast cancer before giving detailed insight into promising pipeline targets and deal activity in the breast cancer market.

Scope

-Unmet need is extremely high in late-stage breast cancer.
-What are the most important etiological risk factors and pathophysiological processes implicated in breast cancer-
-What is the current treatment algorithm-
-How effective are current therapies for these indications, and how does this impact prognosis-
-The breast cancer pipeline is large and contains a very high proportion of first-in-class product innovation.
-Which molecule types and molecular targets are most prominent across the breast cancer pipeline-
-What are the relationships between established and up-coming molecular targets in breast cancer-
-Which first-in-class targets are most promising-
-How does first-in-class target diversity differ by stage of development and molecular target class-
-The deals landscape is active and dominated by very high and very low deal values.
-Which indications attract the highest deal values-
-How has deal activity fluctuated over the past decade-
-Which first-in-class pipeline products have no prior involvement in licensing or co-development deals-

Reasons to buy

-Appreciate the current clinical and commercial landscapes by considering disease symptoms, pathogenesis, etiology, co-morbidities and complications, epidemiology, diagnosis, prognosis and treatment options.
-Identify leading products and key unmet needs within the market.
-Recognize innovative pipeline trends by analyzing therapies by stage of development, molecule type and molecular target.
-Assess the therapeutic potential of first-in-class targets. Using proprietary matrix assessments, first-in-class targets in the pipeline have been assessed and ranked according to clinical potential.
-Consider first-in-class pipeline products with no prior involvement in licensing and co-development deals, which may represent potential investment opportunities.

Table of Contents:

1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 Executive Summary 6
2.1 Exceptionally Large and Innovative Pipeline 6
2.2 Alignment of First-in-Class Molecular Target with Disease Causation 6
2.3 Highly Active Deals Landscape with Numerous Investment Opportunities 6
3 The Case for Innovation 7
3.1 Growing Opportunities for Biologic Products 7
3.2 Diversification of Molecular Targets 8
3.3 Innovative First-in-Class Product Developments Remain Attractive 8
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Innovation 9
3.5 Sustained Innovation in Breast Cancer 9
3.6 Report Guidance 9
4 Clinical and Commercial Landscape 11
4.1 Overview of Breast Cancer 11
4.2 Symptoms 11
4.3 Diagnosis 11
4.4 Etiology 12
4.4.1 Age and Gender 12
4.4.2 Genetics 12
4.4.3 Environmental 13
4.5 Pathophysiology 13
4.5.1 Tumor Initiation and Aberrant Cell Proliferation and Survival 13
4.5.2 Tumor Metabolic Shift 14
4.5.3 Tumor Progression, Micro-environment Alteration and Angiogenesis 15
4.5.4 Cancer Stem Cells 16
4.6 Epidemiology 16
4.7 Complications 17
4.8 Prognosis and Disease Staging 18
4.8.1 Classification 19
4.9 Introduction to Breast Cancer Treatments 20
4.9.1 Treatment Algorithm 20
4.9.2 Treatment Options for Breast Cancer 22
4.10 Overview of Marketed Products in Breast Cancer 26
4.11 Current Unmet Needs in the Breast Cancer Market 27
5 Assessment of Pipeline Product Innovation 29
5.1 Overview 29
5.2 Breast Cancer Pipeline by Phase of Development and Molecule Type 29
5.3 Pipeline by Molecular Target 30
5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 32
5.5 Comparative Distribution of First-in-Class and Non-First-in-Class Pipeline Programs by Molecular Target Class 32
5.5.1 Percentage Distribution of First-in-Class and Non-First-in-Class Pipeline Programs 35
5.6 Ratio of First-In-Class Programs to First-in-Class Molecular Targets within the Pipeline 36
5.7 List of All First-in-Class Pipeline Programs 38
6 Signaling Network, Disease Causation and Innovation Alignment 62
6.1 Complexity of Signaling Networks in Breast Cancer 62
6.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 62
6.3 First-in-Class Molecular Target Matrix Assessment 63
7 First-in-Class Target Evaluation 70
7.1 Pipeline Programs Targeting PI3K Catalytic Subunit Alpha Isoform (PI3KCA) 70
7.2 Pipeline Programs Targeting GTPase KRAS (K-ras) 71
7.3 Pipeline Programs Targeting Cluster of Differentiation 47 (CD47) 72
7.4 Pipeline Programs Targeting CD278 (ICOS gene product) 74
7.5 Pipeline Programs Targeting Stimulator of Interferon Genes (TMEM173 gene product) 74
7.6 Pipeline Programs Targeting Receptor Tyrosine Protein Kinase ERBB 3 (HER3) 76
7.7 Pipeline Programs Targeting Neuregulin-1 (NRG1) 79
7.8 Pipeline Programs Targeting Calcium Release-Activated Calcium Channel Protein 1 (ORAI1) 80
7.9 Conclusion 81
8 Strategic Consolidations 83
8.1 Industry-Wide First-in-Class Deals 83
8.2 Breast Cancer Deals Landscape 84
8.3 Licensing Deals 85
8.3.1 Deals by Region, Value and Year 85
8.3.2 Deals by Stage of Development and Value 86
8.3.3 Deals by Molecule Type and Molecular Target 87
8.3.4 List of Deals with Disclosed Deal Values 88
8.4 Co-development Deals 92
8.4.1 Deals by Region, Value and Year 92
8.4.2 Deals by Stage of Development and Value 93
8.4.3 Deals by Molecule Type and Molecular Target 94
8.4.4 List of Deals with Disclosed Deal Values 95
8.5 First-In-Class Programs with and without Prior Licensing or Co-development Deal Involvement 96
9 Appendix 105
9.1 Abbreviations 105
9.2 References 106
9.3 Methodology 120
9.3.1 Data integrity 120
9.3.2 Innovative and Meaningful Analytical Techniques and Frameworks 120
9.3.3 Evidence Based Analysis and Insight 120
9.4 Secondary Research 120
9.4.1 Market Analysis 121
9.4.2 Pipeline Analysis 121
9.4.3 Licensing and Co-development Deals 121
9.5 Contact Us 122
9.6 Disclaimer 122

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Pune, India

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