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Triple Analysis: Protein Kinase Inhibitors, Antibodies and Vaccines in Oncology

Published by: BioSeeker Group AB

Published: Aug. 3, 2006 - 305 Pages


Table of Contents


1 Executive Summary




2 Table of Contents

2.1 List of Boxes

2.2 List of Figures

2.3 List of Tables




3 Methodology




4 Protein Kinase Inhibitors

4.1 Rationale for Development of Kinase Inhibitors in Oncology

4.2 Protein Kinase Targets - A Growing Family

4.3 Challenges in Protein Kinase Drug Discovery


4.3.1 Enabling Structure-Based Drug Design is the Key

4.3.2 Specific Kinase Inhibitors without Kinase Profiling?


4.4 Drugs according to Target


4.4.1 Cyclin-dependent Kinase Target Inhibitors

4.4.2 Aurora Kinase Target Inhibitors

4.4.3 Cell Cycle Checkpoint Target Controls Inhibitors

4.4.4 Tyrosine Kinase Receptor Inhibitors

4.4.5 Other Serine/Threonine Kinase Target Inhibitors


4.5 Dual or Multiple Kinase Inhibitor Analysis


4.5.1 Presentation of Drugs Targeting A to F Kinases

4.5.2 Presentation of Drugs Targeting G to T Kinases


4.6 Targets According to Indication


4.6.1 Breast Cancer

4.6.2 Prostate Cancer: What Cannot be Found in the ‘Groins’?

4.6.3 Lung Cancer: A Need for Improved Survival Rates

4.6.4 Colorectal Cancer: EGFR & VEGFR are Strong Targets but There are Others

4.6.5 Leukemia: Show Me the Power of PKI

4.6.6 Melanoma

4.6.7 Lymphoma: We Are In


4.7 Growing Competition in the Field

4.8 Big Pharma Outlook: The Race is On


4.8.1 Novartis Deals - Digs Deeper into Cell Cycle Inhibitors

4.8.2 AstraZeneca - Wheeling and Dealing

4.8.3 Pfizer’s Long Look at OSI Pharmaceuticals

4.8.4 GlaxoSmithKline Gains Momentum


4.9 Strategic Deals Creating Competitive Edge


4.9.1 Mergers

4.9.2 Astex - the PKI Switchboard

4.9.3 Big Pharma’s Darling


4.10 Current Protein Kinase Inhibitors in Therapy


4.10.1 Mechanism, Target and Developmental History

4.10.2 Approvals: Indications & Markets


4.11 Protein Kinase Inhibitors in Drug Development - A Progress Analysis


4.11.1 Progress Analysis - Breast Cancer

4.11.2 Progress Analysis - Prostate Cancer

4.11.3 Progress Analysis - Lung Cancer

4.11.4 Progress Analysis - Colorectal Cancer

4.11.5 Progress Analysis - Leukemia

4.11.6 Progress Analysis - Melanoma

4.11.7 Progress Analysis - Lymphoma




5 Immunotherapy in Oncology

5.1 Vaccine Strategies: Challenges & Opportunities

5.2 Key Antibody Developmental Strategies




6 Competitive Landscape in Cancer Vaccines

6.1 Countries & Players: Who are In the Lead?


6.1.1 Top 10 Players Constitute Up to One Third of R&D: Big Pharma Not Included!

6.1.2 Approved Cancer Vaccine Drugs: Performance


6.2 Deals & Alliances in Cancer Vaccines


6.2.1 Recent Mergers & Acquisitions in Cancer Vaccines

6.2.2 Deals in Prostate Cancer

6.2.3 Deals in Breast Cancer

6.2.4 Deals in Leukemia & Lymphoma

6.2.5 Drug Delivery Deals in Cancer Vaccines

6.2.6 Adjuvant Deals




7 Antibody Deals on the Rise

7.1 Antibody Deals in Phase III


7.1.1 Deal Situation: MDX 010

7.1.2 Deal Situation: WX G250

7.1.3 Deal Situation: Zanolimumab


7.2 Antibody Deals in Phase II


7.2.1 Deal Situation: Mapatumumab

7.2.2 Deal Situation: GCR 3888

7.2.3 Deal Situation: MDX 070

7.2.4 Deal Situation: CDP 860

7.2.5 Deal Situation: Tru-Scint OV

7.2.6 Deal Situation: SC 1

7.2.7 Deal Situation: PRO 70769

7.2.8 Deal Situation: XR 303

7.2.9 Deal Situation: HumaRAD-HN




8 Tumor Antigens

8.1 Tumor Antigens: General Comments

8.2 Antigen Discovery


8.2.1 Classical Immunology Approach

8.2.2 The Reverse Immunology Approach

8.2.3 Company Platforms


8.3 Specific Antigen Processing Technologies Increasing Antigen Presentation




9 Immunomodulators & Adjuvants in Cancer Vaccines

9.1 Overview

9.2 Cytokines


9.2.1 Vaccines in Combination with Interleukin-2

9.2.2 Tumor Necrosis Factor

9.2.3 Interferons


9.3 Adjuvants

9.4 Other Immunomodulating Strategies


9.4.1 An Immune Response Modifying Protein

9.4.2 Immunostimulatory DNA

9.4.3 Ex Vivo Stimulated Immune Cells

9.4.4 Fusion Protein Gain Potent Immune Response

9.4.5 Macrophage and Natural Killer Cells Activation

9.4.6 Selective Suppression of the Immune System to An Antigen

9.4.7 TAP Technology




10 Cancer Vaccine Delivery

10.1 Viral Delivery


10.1.1 Introduction

10.1.2 Viral Constructs Put into Use


10.2 Bacterias

10.3 Cell Therapy: Dendritic-cell Based & Cancer-Cell Based Therapies


10.3.1 Introduction

10.3.2 Cell Therapy Strategies


10.4 Synthetic Delivery Systems & Strategies


10.4.1 Introduction

10.4.2 Biotransport™

10.4.3 Biotype®vector

10.4.4 DNAVax Gene Delivery System

10.4.5 FusitAb™

10.4.6 GeneDrug™

10.4.7 Molecular Conjugates

10.4.8 Naked DNA Delivery

10.4.9 PVLP Technology

10.4.10 Sphingosomal Drug Delivery Technology

10.4.11 STEALTH

10.4.12 Failed Liposomal Systems




11 New Approaches in Antibody Delivery and Design - The Next Generation

11.1 How to Make Them Smaller and Different?

11.2 Biomaterials in Sustained Delivery Applications


11.2.1 Implants


11.3 Gene delivery - the Future?


11.3.1 Delivery Vehicles for DNA

11.3.2 Gene Delivery in Commercialization




12 Cancer Vaccines in Development: By Major Indications

12.1 General Oncology Overview

12.2 Progress Analysis - Melanoma

12.3 Progress Analysis - Breast Cancer

12.4 Progress Analysis - Prostate Cancer

12.5 Progress Analysis - Lung Cancer

12.6 Progress Analysis - Colorectal Cancer

12.7 Progress Analysis - Cervical Cancer




13 Antibodies in Clinical Development


13.1.1 Prostate Cancer Therapeutics

13.1.2 Breast Cancer Therapeutics

13.1.3 Colorectal Cancer Therapeutics

13.1.4 Melanoma Therapeutics

13.1.5 Hematological Cancers Therapeutics


13.2 Antibodies in Phase III Clinical Development


13.2.1 Progress Analysis: IGN 101

13.2.2 Progress Analysis: MDX 010

13.2.3 Progress Analysis: ONYVAX 105

13.2.4 Progress Analysis: Ovarex

13.2.5 Progress Analysis: Panitumumab

13.2.6 Progress Analysis: RENCAREX

13.2.7 Progress Analysis: Nimotuzumab

13.2.8 Progress Analysis: TransMID

13.2.9 Progress Analysis: Lintuzumab

13.2.10 Progress Analysis: Zanolimumab


13.3 Antibodies in Phase II Clinical Development


13.3.1 Progress Analysis: ABT-510

13.3.2 Progress Analysis: BB 10901

13.3.3 Progress Analysis: CP 675206

13.3.4 Progress Analysis: CNTO-328

13.3.5 Progress Analysis: Ecromeximab

13.3.6 Progress Analysis: EMD 273063

13.3.7 Progress Analysis: WX-G250RIT

13.3.8 Progress Analysis: HGS-ETR1

13.3.9 Progress Analysis: HuMax-CD20

13.3.10 Progress Analysis: HuMax-EGFr

13.3.11 Progress Analysis: Galiximab

13.3.12 Progress Analysis: PROXINIUM

13.3.13 Progress Analysis: RAV12

13.3.14 Progress Analysis: SGN-15

13.3.15 Progress Analysis: SGN-30

13.3.16 Progression Analysis: VEGF-Trap

13.3.17 Progress Analysis: MEDI 522

13.3.18 Progress Analysis: Volociximab




14 Disclaimer




15 Company Index




16 Drug Index




2.1 List of Boxes

Box 1: The Power of Ambit’s Kinase Profiling

Box 2: Summary Terms of the Exelixis Transaction

Box 3: Mechanisms Which Tumor Cells Use to Evade an Immune Reaction

Box 4: M-VAX - Business & Market Bakground

Box 5: Gardasil: Business & Market Background

Box 6: The Principal Terms of Deal between AstraZeneca and Cambridge Antibody Technology

Box 7: TNF in Cancer Treatments

Box 8: Marrion’s Drug Delivery Technology

Box 9: Quick Facts - IGN 101

Box 10: Quick Facts - MDX 010

Box 11: Quick Facts - ONYVAX 105

Box 12: Quick Facts - Ovarex

Box 13: Quick Facts - Panitumumab

Box 14: Quick Facts - RENCARNEX

Box 15: Quick Facts - Nimotuzumab

Box 16: Quick Facts - RENCARNEX

Box 17: Quick Facts - Lintuzumab

Box 18: Quick Facts - Zanolimumab

Box 19: Quick Facts - ABT-510

Box 20: Quick Facts - BB 10901

Box 21: Quick Facts - CP-675206

Box 22: Quick Facts - CNTO-328

Box 23: Quick Facts - Ecromeximab

Box 24: Quick Facts - EMD-273063

Box 25: Quick Facts - WX-G250RIT

Box 26: Quick Facts - HGS-ETR1

Box 27: Quick Facts - HuMax-CD20

Box 28: Quick Facts - HuMax-EGFr

Box 29: Quick Facts - Galiximab

Box 30: Quick Facts - PROXINIUM

Box 31: Quick Facts - RAV12

Box 32: Quick Facts -SGN-15

Box 33: Quick Facts -SGN-30

Box 34: Quick Facts - VEGF-Trap

Box 35: Quick Facts - MEDI 522

Box 36: Quick Facts - Volociximab




2.2 List of Figures

Figure 1 Top 10 PKI Drug Developing Companies

Figure 2 Clinical Trial Distribution in Breast Cancer for PKI Drugs

Figure 3 Clinical Trial Distribution in Prostate Cancer for PKI Drugs

Figure 4 Clinical Trial Distribution in Lung Cancer for PKI Drugs

Figure 5 Clinical Trial Distribution in Colorectal Cancer for PKI Drugs

Figure 6 Clinical Trial Distribution in Leukemia for PKI Drugs

Figure 7 Clinical Trial Distribution in Melanoma for PKI Drugs

Figure 8: Clinical Trial Distribution in Lymphoma for PKI Drugs

Figure 9: Top 10 Countries in Cancer Vaccine Research

Figure 10: Top 10 Companies’ Clinical Trial Progress in Cancer Vaccine

Figure 11: 2003-2005 Deals & Alliances in Cancer Vaccine

Figure 12: Distribution of Cancer Vaccine Trials in Melanoma

Figure 13: Distribution of Cancer Vaccine Trials in Breast Cancer

Figure 14: Distribution of Cancer Vaccine Trials in Prostate Cancer

Figure 15: Distribution of Cancer Vaccine Trials in Lung Cancer

Figure 16: Distribution of Cancer Vaccine Trials in Colorectal Cancer

Figure 17: Distribution of Cancer Vaccine Trials in Cervical Cancer




2.3 List of Tables

Table 1: Overview of Targets in Commercial Development

Table 2: Cyclin-dependent Kinase Targets in Development

Table 3: Aurora Kinase Targets in Development

Table 4: Cell Cycle Checkpoint Targets in Development

Table 5: Epidermal Growth Factor Receptor Targets in Development

Table 6: FMS-like tyrosine kinases and their Synonyms

Table 7: Fms-related Tyrosine Kinase Targets in Development

Table 8: Platelet-derived Growth Factor Receptor Targets in Development

Table 9: Kinase Insert Domain Targets in Development

Table 10: Drugs in Development Targeting the PI3K/Akt/mTOR pathway

Table 11: Drugs in Development Targeting the Ras-Raf-MEK-ERK (ERK) pathway

Table 12: Serine/Threonine Kinase Inhibitors in Development

Table 13: Protein Kinase Targets in Clinical Trials for Breast Cancer

Table 14: Protein Kinase Targets in Clinical Trials for Prostate Cancer

Table 15: Protein Kinase Targets in Clinical Trials for Lung Cancer

Table 16: Protein Kinase Targets in Clinical Trials for Colorectal Cancer

Table 17: Protein Kinase Targets in Clinical Trials for Leukemia

Table 18: Protein Kinase Targets in Clinical Trials for Melanoma

Table 19: Protein Kinase Targets in Clinical Trials for Lymphoma

Table 20: Drugs in Therapy - Mechanism & Targets

Table 21: Current and Developmental History of PKI Drugs in Therapy

Table 22: Approvals: Indications & Markets

Table 23: Top 10 Drugs in Terms of Number of Clinical Trials

Table 24: List of Cancer Indications Targeted by Protein Kinase Inhibitors

Table 25: PKI Drugs in Development for Breast Cancer

Table 26: PKI Drugs in Development for Prostate Cancer

Table 27: PKI Drugs in Development for Lung Cancer

Table 28: PKI Drugs in Development for Colorectal Cancer

Table 29: PKI Drugs in Development for Leukemia

Table 30: PKI Drugs in Development for Melanoma

Table 31: PKI Drugs in Development for Lymphoma

Table 32: Summary of Strategies Enhancing Antibody Function

Table 33: Companies with Cancer Vaccine Drugs on Market

Table 34: Antigen Classification

Table 35: Platforms Used to Improve Antigen Presentation

Table 36: Cancer Vaccines in Clinical Trials in Combination with Interleukin-2

Table 37: Adjuvants in Cancer Vaccines

Table 38: Synthetic Delivery Systems Deployed in Cancer in General and Cancer Vaccines in

Particular

Table 39: Potential Advantages in Local, Controlled-Release for Therapeutic Antibodies

Table 40: Drug Delivery Companies with Cancer Focus

Table 41: FDA Approved Polymer-based Drug Delivery Systems for Cancer

Table 42 Top 10 Cancer Indications in Non-Antibody Based Cancer Vaccines

Table 43: Discountinued Phase I to Phase III Cancer Vaccine Drugs

Table 44: List of Phase I to Phase III Cancer Vaccines in Development for Melanoma

Table 45: List of Phase I to Phase III Cancer Vaccines in Development for Breast Cancer

Table 46: List of Phase I to Phase III Cancer Vaccines in Development for Prostate Cancer

Table 47: List of Phase I to Phase III Cancer Vaccines in Development for Lung Cancer

Table 48: List of Phase I to Phase III Cancer Vaccines in Development for Colorectal Cancer

Table 49: List of Phase I to Phase III Cancer Vaccines in Development for Cervical Cancer

Table 50: Antibody Therapeutics in Prostate Cancer

Table 51: Antibody Therapeutics in Breast Cancer

Table 52: Antibody Therapeutics in Colorectal Cancer

Table 53: Antibody Therapeutics in Melanoma

Table 54: Antibody Therapeutics in Hematological Cancer

Table 55: MDX-010’s Collaborative History and Landscape

Abstract

Executive Summary

In this triple analysis report BioSeeker Group has analyzed three major and intertwined areas of cancer R&D, Protein Kinase Inhibitors (PKI), Antibodies and Vaccines in Oncology, which are all subjects to an extensive number of innovative drug candidates. This extensive 300+ pages report compiles and analyzes in parallel the progress concerning drug development and competitive situation in the three mentioned key oncology areas. The report will not only provide a framework but also a careful identification and evaluation of drug candidates, technologies and competitors.

The number of protein kinase inhibitor drugs has risen sharply, as the number of targets. The fiercest competition in PKI drug development is found in breast, lung, leukemia, prostate, and colorectal cancer. Several big pharma companies are out hunting for promising technology and drugs to complement their internal pipeline. The perfect date between Gleevec and Chronic Myeloid Leukemia (CML) will however be hard to achieve by other inhibitors currently in development, because of CMLïs strong link to a sole pathogenic event - the Philadelphia chromosome. Thus, it is expected that multiple inhibitors may have to be used together to effect higher cure rates in cancers with multiple genetic abnormalities.

Protein Kinase Inhibitors Highlights:
  • Drugs according to protein kinase target; Dual or multiple kinase inhibitor analysis
  • Targets according to indication
  • Competitive landscape assessment
  • Protein kinase inhibitors on market
  • Thorough review of the seven largest cancer indications in the field of protein kinase inhibitors
Among the targeted therapies for cancer, immunotherapy is probably the most versatile treatment strategy for the eradication of tumors, metastatic spread or not. Main strategies of cancer immunotherapy aim at exploiting the therapeutic potential of tumor-specific antibodies and cellular immune effector mechanisms (vaccines).

Immunotherapy Highlights:
  • In-depth competitive landscape assessment of the cancer immunotherapy market place; Including more than 200 immunotherapy drugs and pharmaceutical companies
  • Thorough review of tumor antigen discovery, immunomodulating strategies and adjuvants
  • Thorough review of antibody and vaccine delivery and technologies surrounding it - The next generation
  • Progress analysis of six major cancer vaccine indications and late stage antibody development projects, including players, drugs, clinical progress and pitfalls


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