Date Published
January 2016

Page Count 
116

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Table of Contents

Executive Summary

Background

Topics covered in this report

Chapter 1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
Chapter 6
Chapter 7
Chapter 8
Outlook for combination antibody therapeutics 

CHAPTER 1
Introduction, Scope and Objectives 
A brief review of the clinical efficacy and market status of currently approved antibody-based drugs for cancer therapy
Bevacizumab
Necitumumab
Dinutuximab.
Nivolumab.
Blinatumomab
Pembrolizumab
Ramucirumab
Obinutuzumab
Ado-trastuzumab emtansine
Ipilimumab: Immune checkpoint inhibitors
Pertuzumab.
Opportunities and challenges for future development 
1.2.1. A need for targets.
Safety concerns. 
Objectives and outlook for combination antibody therapy 
1.3.1. Overcoming resistance to anti-cancer agents.
1.3.2. Uncertainties in combined antibody therapy.
1.4. Summary  

CHAPTER 2
Targeted Antibody Therapeutics
2.1. The unstable cancer genome.
2.2. The epigenome.
2.3. Chemotherapy treatment combined with antibodies
2.4. Combinations of targeted antibodies
2.5. Targeted antibody therapeutics and the marketplace
2.6. Targeted antibody therapeutics in the clinic
2.7. Summary 

CHAPTER 3
Immuno-Antibody Therapeutics 
Development and Current Products 
Combination of Chemotherapy and Immuno-antibody therapeutics 
Combinations of immune-antibodies 
Immuno- antibody therapeutics in the marketplace 

3.5. Immuno- antibody therapeutics in the clinic
Summary 

CHAPTER 4
Fusion Antibody Therapeutics 

4.1. Antibody Drug Conjugates (ADCs)
Antibody Biologic Constructs (ABCs) 
Immunocytokines 
Fusion antibodies in combination with other drugs 
Summary 

CHAPTER 5
Multitargeted and Polyfunctional Antibody Therapeutics 

5.1. Status and clinical studies of Bispecific and bi-targeted antibodies
5.2. Recombinant polyclonal antibodies
5.3. Combination therapy
5.4. Challenges in manufacturing
5.5. Regulatory areas: Challenges
5.5. Summary 

CHAPTER 6
Patent Expiration and the Rise of Biosimilars 

6.1. Introduction
Biosimilar antibodies in the market 
Target products nearing patent expiration 
Prospects for biobetters 
A bright future for modified antibodies 
Summary 

CHAPTER 7
Deals and the Marketplace 

7.1. Mergers and acquisitions
7.3. The Mother of all Mergers
7.4. Summary 

CHAPTER 8
Strategic Issues 
8.1. Balancing basic and clinical research
8.1.1. A troubled time for the life sciences
8.1.2. Shoddy and questionable research
8.1.3. A resolution to the funding crisis?
8.1.4. Promising areas of discovery in cancer combination therapies
8.1.4.1. CTLA-4.
8.1.4.2. CD-38.
8.1.4.3. Rectal cancer therapies
New approaches to oncology: Diagnostics versus therapeutics 
8.2.1. The frustrating search for effective disease biomarkers
8.2.2. A mix of approaches to cancer biomarker discovery.
8.2.3. Three approaches to immunodiagnostic cancer markers
8.2.3.1. The first is the traditional approach of characterization of a single cancer-related marker and its validation as an immunodiagnostic test.
8.2.3.2. The second approach has evolved as sophisticated instrumentation for multiplexing has become more widely available.
8.2.3.3. Yet a third approach is a more indirect one – identifying tumor-specific antibodies in the serum of affected individuals.
8.2.4. Current cancer markers in use
8.3. Opportunities and pitfalls
8.3.1. NCI-MATCH trials
8.3.2. A wide range of treatments offers better odds of survival.
Summary 

CHAPTER 9
Interviews with Experts in the Field 

9.1. Interview with Esper Boel, SVP, head of discovery; Ivan Horak, CSO; and Mads Laustsen, CMO at Symphogen
9.2. Interview with Eric S. Langer, Managing Partner, BioPlan Associates, Inc.
9.3. Interview with Dr. Laurent Ducry, Group Leader Bioconjugates R&D, Lonza, Valais, Switzerland
9.4. Interview with Dr. Cheng Liu, CEO, Eureka Therapeutics
9.5. Interview with Steve King, President, Peregrine Pharma 

CHAPTER 10
Questionnaire put to Industry Representatives Concerning Developments in Antibody Technology 
References 
About Cambridge Healthtech Institute 

FIGURES
Figure 1.1.7.1. 
Figure 1.1.8.1. Timeline for development of ipilimumab.
Figure 1.1.11.1. Binding sites on human epidermal growth factor receptor 2 (HER2) for FDA-approved HER2-directed therapies
Figure 2.1. Mechanisms that drive drug resistance in cancer cells
Figure 2.2.1. Depiction of the Primary Mechanisms that Enable Cancer Cells to Become Drug Resistant
Figure 3.1.1. Flash Gordon Comic Strip from the 1950s.
Figure 3.1. The Il-2 pathway.
Figure 3.2.1. MAPK Pathway and Mechanism of Vemurafenib
Figure 3.3.1. Domain Architecture and Affinity Purification of a scFv:CD40L Fusion Proteins
Figure 5.1.1. Alternative possibilities for bispecific Antibodies.
Figure 8.2.1.1. Biomarker discovery over the last 30 years
Figure 8.4.1. Rate of new drug approvals. 

TABLES
Table 1.1. FDA-Approved Epigenetic Therapies
Table 3.1.1. Currently Approved Non-mAb Anticancer Immunotherapeutics.
Table 4.1.1. Seattle Genetics ADCs in clinical trials
Table 5.2.1. Examples of Oligoclonal and polyclonal antibody therapeutics in development.
Table 6.XX: Needs a Title
Table 7.1: Merger and Acquisition Trends