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Triple Analysis: Melanoma Therapeutics, Antibodies and Vaccines in Oncology

Published by: BioSeeker Group AB

Published: Aug. 3, 2006 - 388 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 Melonoma Etiology and Pathophysiology




5 Key Therapy Strategies


5.1.1 Immunotherapy

5.1.2 Cancer Vaccines

5.1.3 Antiangiogenesis

5.1.4 Gene Therapy




6 Current Treatment Regimens

6.1 An Overview

6.2 Cytotoxic Drugs


6.2.1 Dacarbazine

6.2.2 Cisplatin

6.2.3 Carboplatin

6.2.4 Carmustine

6.2.5 Melphalan

6.2.6 Paclitaxel

6.2.7 Tamoxifen

6.2.8 Temozolomide

6.2.9 Vinblastine/Vinorelbine


6.3 Biological treatments


6.3.1 Virulizin

6.3.2 Melacine

6.3.3 Alfanative (Multiferon)

6.3.4 Proleukin or (Macrolin)

6.3.5 Ceplene Maxamine




7 Competitive Lanscape in Melanoma R&D


7.1.1 Phase I & II R&D Collaborations in Melanoma: Oxxon

7.1.2 Roche links Schering-Plough and Chugai Clusters Together - What Will the Outcome Be?

7.1.3 GlaxoSmithKline Brings Wyeth, Hayashibara, Cytokinetics and Coley Pharmaceuticals Together

7.1.4 GlaxoSmithKline and Sanofi-Aventis have a Joint Middle Man

7.1.5 R&D Collaboration Trends in Melanoma Projects




8 Current Melanoma Drug Development

8.1 Vaccines: Active Immunotherapy a Benefit or Not?


8.1.1 Vaccine: Direct Immunization with Tumor Antigens

8.1.2 Vaccines: Is the Development of Cell Therapy Stalling?

8.1.3 DNA Vaccine

8.1.4 Optimism for New Vaccine Adjuvants


8.2 Immunostimulants: The Push in Passive Immunotherapy


8.2.1 Immuno-Biologicals: The Work Horse

8.2.2 Immunostimulation by Gene Therapy

8.2.3 One Small Molecular Drug Candidate


8.3 Antiangiogenesis- The Major Research Focus for the Next Decade?

8.4 Apoptosis Inducers: Moving into Market

8.5 Small Molecules Inhibiting Cell Growth Faces Difficulties

8.6 Other Biological Drugs




9 Immunotherapy in Oncology

9.1 Vaccine Strategies: Challenges & Opportunities

9.2 Key Antibody Developmental Strategies




10 Competitive Landscape in Cancer Vaccines

10.1 Countries & Players: Who are In the Lead?


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

10.1.2 Approved Cancer Vaccine Drugs: Performance


10.2 Deals & Alliances in Cancer Vaccines


10.2.1 Recent Mergers & Acquisitions in Cancer Vaccines

10.2.2 Deals in Prostate Cancer

10.2.3 Deals in Breast Cancer

10.2.4 Deals in Leukemia & Lymphoma

10.2.5 Drug Delivery Deals in Cancer Vaccines

10.2.6 Adjuvant Deals




11 Antibody Deals on the Rise

11.1 Antibody Deals in Phase III


11.1.1 Deal Situation: MDX 010

11.1.2 Deal Situation: WX G250

11.1.3 Deal Situation: Zanolimumab


11.2 Antibody Deals in Phase II


11.2.1 Deal Situation: Mapatumumab

11.2.2 Deal Situation: GCR 3888

11.2.3 Deal Situation: MDX 070

11.2.4 Deal Situation: CDP 860

11.2.5 Deal Situation: Tru-Scint OV

11.2.6 Deal Situation: SC 1

11.2.7 Deal Situation: PRO 70769

11.2.8 Deal Situation: XR 303

11.2.9 Deal Situation: HumaRAD-HN




12 Tumor Antigens

12.1 Tumor Antigens: General Comments

12.2 Antigen Discovery


12.2.1 Classical Immunology Approach

12.2.2 The Reverse Immunology Approach

12.2.3 Company Platforms


12.3 Specific Antigen Processing Technologies Increasing Antigen Presentation




13 Immunomodulators & Adjuvants in Cancer Vaccines

13.1 Overview

13.2 Cytokines


13.2.1 Vaccines in Combination with Interleukin-2

13.2.2 Tumor Necrosis Factor

13.2.3 Interferons


13.3 Adjuvants

13.4 Other Immunomodulating Strategies


13.4.1 An Immune Response Modifying Protein

13.4.2 Immunostimulatory DNA

13.4.3 Ex Vivo Stimulated Immune Cells

13.4.4 Fusion Protein Gain Potent Immune Response

13.4.5 Macrophage and Natural Killer Cells Activation

13.4.6 Selective Suppression of the Immune System to An Antigen

13.4.7 TAP Technology




14 Cancer Vaccine Delivery

14.1 Viral Delivery


14.1.1 Introduction

14.1.2 Viral Constructs Put into Use


14.2 Bacterias

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


14.3.1 Introduction

14.3.2 Cell Therapy Strategies


14.4 Synthetic Delivery Systems & Strategies


14.4.1 Introduction

14.4.2 Biotransport™

14.4.3 Biotype®vector

14.4.4 DNAVax Gene Delivery System

14.4.5 FusitAb™

14.4.6 GeneDrug™

14.4.7 Molecular Conjugates

14.4.8 Naked DNA Delivery

14.4.9 PVLP Technology

14.4.10 Sphingosomal Drug Delivery Technology

14.4.11 STEALTH

14.4.12 Failed Liposomal Systems




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

15.1 How to Make Them Smaller and Different?

15.2 Biomaterials in Sustained Delivery Applications


15.2.1 Implants


15.3 Gene delivery - the Future?


15.3.1 Delivery Vehicles for DNA

15.3.2 Gene Delivery in Commercialization




16 Cancer Vaccines in Development: By Major Indications

16.1 General Oncology Overview

16.2 Progress Analysis - Melanoma

16.3 Progress Analysis - Breast Cancer

16.4 Progress Analysis - Prostate Cancer

16.5 Progress Analysis - Lung Cancer

16.6 Progress Analysis - Colorectal Cancer

16.7 Progress Analysis - Cervical Cancer




17 Antibodies in Clinical Development


17.1.1 Prostate Cancer Therapeutics

17.1.2 Breast Cancer Therapeutics

17.1.3 Colorectal Cancer Therapeutics

17.1.4 Melanoma Therapeutics

17.1.5 Hematological Cancers Therapeutics


17.2 Antibodies in Phase III Clinical Development


17.2.1 Progress Analysis: IGN 101

17.2.2 Progress Analysis: MDX 010

17.2.3 Progress Analysis: ONYVAX 105

17.2.4 Progress Analysis: Ovarex

17.2.5 Progress Analysis: Panitumumab

17.2.6 Progress Analysis: RENCAREX

17.2.7 Progress Analysis: Nimotuzumab

17.2.8 Progress Analysis: TransMID

17.2.9 Progress Analysis: Lintuzumab

17.2.10 Progress Analysis: Zanolimumab


17.3 Antibodies in Phase II Clinical Development


17.3.1 Progress Analysis: ABT-510

17.3.2 Progress Analysis: BB 10901

17.3.3 Progress Analysis: CP 675206

17.3.4 Progress Analysis: CNTO-328

17.3.5 Progress Analysis: Ecromeximab

17.3.6 Progress Analysis: EMD 273063

17.3.7 Progress Analysis: WX-G250RIT

17.3.8 Progress Analysis: HGS-ETR1

17.3.9 Progress Analysis: HuMax-CD20

17.3.10 Progress Analysis: HuMax-EGFr

17.3.11 Progress Analysis: Galiximab

17.3.12 Progress Analysis: PROXINIUM

17.3.13 Progress Analysis: RAV12

17.3.14 Progress Analysis: SGN-15

17.3.15 Progress Analysis: SGN-30

17.3.16 Progression Analysis: VEGF-Trap

17.3.17 Progress Analysis: MEDI 522

17.3.18 Progress Analysis: Volociximab




18 Disclaimer




19 Company Index




20 Drug Index




21 Appendix I: Treatment Guide Lines Melanoma




2.1 List of Boxes

Box 1: Mechanisms which tumor cells use to evade an immune reaction

Box 2: Introgen’s INGN 241 Shows Vaccine Properties

Box 3: Quick Facts - Oncophage

Box 4: Oncophage - Designation and Status

Box 5: Quick Facts - GM2-KLH Vaccine

Box 6 Progenics reaquires rights to vaccine

Box 7: Completed Melanoma Phase III trials

Box 8: Quick Facts - NovaVac-M1

Box 9: Quick Facts - SB 249553

Box 10: Quick Facts - MJV 101

Box 11: Quick Facts - Russian Melanoma Vaccine

Box 12: Quick Facts - GV 1001

Box 13: Quick Facts - N-Acetyl-GM3 ganglioside

Box 14: Quick Facts: neu-glycolyl-GM3 ganglioside

Box 15: Quick Facts - NY-ESO-1 ISCOMS

Box 16: NY-ESO-1 and ISCOMATRIX

Box 17: Quick Facts - F 50040

Box 18: KpOmpA technology

Box 19: Quick Facts - TransVax

Box 20: Quick Facts - Canvaxin

Box 21: Canvaxin - Designation and Status

Box 22: CancerVax Milestone payment

Box 23: Quick Facts - Dexosome

Box 24: Important Milestones and License Fees

Box 25: Quick Facts - M-VAX

Box 26: Quick Facts -OncoVax

Box 27: Quick Facts - Uvidem

Box 28: Agreements Between Sanofi-Aventis and IDM

Box 29: Quick Facts - Alvac-Mage1/Mage3

Box 30: Quick Facts - Oxxon vaccine

Box 31: Quick Facts - Therion’s Melanoma Vaccine

Box 32: Quick Facts - ImmunoVEX trimelan

Box 33: Quick Facts - OncoVEX GM-CSF

Box 34: Quick Facts - GVAX

Box 35: Agreement Japan Tobacco and Cell Genesys

Box 36: Predicted launch of GVAX

Box 37: Quick Facts - Gp100 + MART-1 vaccine

Box 38: Quick Facts - MAGE-3-TK

Box 39: Quick Facts - Enhanzyn

Box 40: Quick Facts - QS-21

Box 41: Quick Facts - ZADAXIN

Box 42: Quick Facts - Mobista

Box 43: Quick Facts - ProMune

Box 44: Quick Facts - Talabostat

Box 45: Quick Facts - MDX-010

Box 46: Quick Facts - Peginterferon alfa-2b

Box 47: Quick Facts - BAY-504798

Box 48: Quick Facts - EMD-273063

Box 49: Quick Facts - Urocidin

Box 50: Quick Facts - CP-675206

Box 51: Quick Facts - ALLOVECTIN-7

Box 52: Quick Facts - Cytokine, Gene therapy

Box 53: Quick Facts - TG 1041

Box 54: Quick Facts - Lenalidomide

Box 55: Introgen’s INGN 241 Shows Anti-angiogenesis Properties

Box 56: Quick Facts - Sorefenib

Box 57: Quick Facts - Vitaxin

Box 58: Quick Facts . Bevacizumab

Box 59: Quick Facts - Endostatin

Box 60: Quick Facts - PI88

Box 61: Quick Facts - Oblimersen

Box 62: Quick Facts - Didemnin B

Box 63: Quick Facts - INGN 241

Box 64: Recent Identification of Molecular Pathways Underlying Activity of Introgen's INGN 241 Anti- Cancer Therapy

Box 65: Quick Facts - KOS 953

Box 66: Quick Facts - Temozomide

Box 67: Molecular Pathways Underlying the Activity of Temozolomide’s Anti-Cancer Therapy

Box 68: Quick Facts - Pivanex

Box 69: Quick Facts - Karenitecin

Box 70: Quick Facts - Lomeguatrib

Box 71: Quick Facts - PD 0325901

Box 72: Quick Facts - SB 715992

Box 73: Quick Facts - INO 1001

Box 74: Quick Facts - CP 4055

Box 75: Quick Facts - AP 12009

Box 76: Quick Facts - Ecromeximab

Box 77: Quick Facts - ILX 651

Box 78: Quick Facts - Kahalalide F

Box 79: Quick Facts - ABX MA1

Box 80: Mechanisms Which Tumor Cells Use to Evade an Immune Reaction

Box 81: M-VAX - Business & Market Bakground

Box 82: Gardasil: Business & Market Background

Box 83: The Principal Terms of Deal between AstraZeneca and Cambridge Antibody Technology

Box 84: TNF in Cancer Treatments

Box 85: Marrion’s Drug Delivery Technology

Box 86: Quick Facts - IGN 101

Box 87: Quick Facts - MDX 010

Box 88: Quick Facts - ONYVAX 105

Box 89: Quick Facts - Ovarex

Box 90: Quick Facts - Panitumumab

Box 91: Quick Facts - RENCARNEX

Box 92: Quick Facts - Nimotuzumab

Box 93: Quick Facts - RENCARNEX

Box 94: Quick Facts - Lintuzumab

Box 95: Quick Facts - Zanolimumab

Box 96: Quick Facts - ABT-510

Box 97: Quick Facts - BB 10901

Box 98: Quick Facts - CP-675206

Box 99: Quick Facts - CNTO-328

Box 100: Quick Facts - Ecromeximab

Box 101: Quick Facts - EMD-273063

Box 102: Quick Facts - WX-G250RIT

Box 103: Quick Facts - HGS-ETR1

Box 104: Quick Facts - HuMax-CD20

Box 105: Quick Facts - HuMax-EGFr

Box 106: Quick Facts - Galiximab

Box 107: Quick Facts - PROXINIUM

Box 108: Quick Facts - RAV12

Box 109: Quick Facts -SGN-15

Box 110: Quick Facts -SGN-30

Box 111: Quick Facts - VEGF-Trap

Box 112: Quick Facts - MEDI 522

Box 113: Quick Facts - Volociximab




2.2 List of Figures

Figure 1. Oxxon’s R&D Collaborations in Melanoma

Figure 2. Schering Plough’s R&D Collaborations in Melanoma

Figure 3. GlaxoSmithKline and Wyeth’s R&D Collaborations in Melanoma

Figure 4. Bristol-Myers Squibb’s and Sanofi-Aventis’ Collaborations in Melanoma

Figure 5: Top 10 Countries in Cancer Vaccine Research

Figure 6: Top 10 Companies’ Clinical Trial Progress in Cancer Vaccine

Figure 7: 2003-2005 Deals & Alliances in Cancer Vaccine

Figure 8: Distribution of Cancer Vaccine Trials in Melanoma

Figure 9: Distribution of Cancer Vaccine Trials in Breast Cancer

Figure 10: Distribution of Cancer Vaccine Trials in Prostate Cancer

Figure 11: Distribution of Cancer Vaccine Trials in Lung Cancer

Figure 12: Distribution of Cancer Vaccine Trials in Colorectal Cancer

Figure 13: Distribution of Cancer Vaccine Trials in Cervical Cancer




2.3 List of Tables

Table 1: Critical Risk Factors for Development of Melanoma

Table 2: Definition and Description of Stages of Melanoma

Table 3: Prognosis of the 4 Stages of Malignant Melanoma

Table 4: Deployed Strategies for Blocking Angiogenesis

Table 5: Current Cytotoxic Drugs for Treatment of Melanoma

Table 6: Development Milestones- Virulizin

Table 7: Development Milestones - Melacine

Table 8: Development Milestones - Alfanative

Table 9: Development Milestones - Proleukin

Table 10: Number of Collaborations and Drugs per Developmental Stage

Table 11: Tumor antigen

Table 12: In vivo gene therapy

Table 13: Cell therapy based platform in pipeline as potential treatment of melanoma

Table 14: Ex vivo gene therapy loading of antigen presenting cells

Table 15: Overview of Immunostimulants in Development based on Type

Table 16: Overview of Immuno-Biologicals

Table 17: MDX-010’s Collaborative History and Landscape

Table 18: Overview of Gene Therapy Drugs for Immunostimulation

Table 19: Anti-angiogenisis Drugs under Development

Table 20: Selected Regulatory Progress of Sorafenib

Table 21: Overview Apoptopic Inducer Drugs

Table 22: Selected Regulatory Progress of Didemin B

Table 23: Overview of Small Molecule Drugs

Table 24: Overview of Various Biological Drugs in Development for Melanoma

Table 25: Summary of Strategies Enhancing Antibody Function

Table 26: Companies with Cancer Vaccine Drugs on Market

Table 27: Antigen Classification

Table 28: Platforms Used to Improve Antigen Presentation

Table 29: Cancer Vaccines in Clinical Trials in Combination with Interleukin-2

Table 30: Adjuvants in Cancer Vaccines

Table 31: Synthetic Delivery Systems Deployed in Cancer in General and Cancer Vaccines in Particular

Table 32: Potential Advantages in Local, Controlled-Release for Therapeutic Antibodies

Table 33: Drug Delivery Companies with Cancer Focus

Table 34: FDA Approved Polymer-based Drug Delivery Systems for Cancer

Table 35 Top 10 Cancer Indications in Non-Antibody Based Cancer Vaccines

Table 36: Discountinued Phase I to Phase III Cancer Vaccine Drugs

Table 37: List of Phase I to Phase III Cancer Vaccines in Development for Melanoma

Table 38: List of Phase I to Phase III Cancer Vaccines in Development for Breast Cancer

Table 39: List of Phase I to Phase III Cancer Vaccines in Development for Prostate Cancer

Table 40: List of Phase I to Phase III Cancer Vaccines in Development for Lung Cancer

Table 41: List of Phase I to Phase III Cancer Vaccines in Development for Colorectal Cancer

Table 42: List of Phase I to Phase III Cancer Vaccines in Development for Cervical Cancer

Table 43: Antibody Therapeutics in Prostate Cancer

Table 44: Antibody Therapeutics in Breast Cancer

Table 45: Antibody Therapeutics in Colorectal Cancer

Table 46: Antibody Therapeutics in Melanoma

Table 47: Antibody Therapeutics in Hematological Cancer

Table 48: 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, Melanoma Therapeutics, Antibodies and Vaccines in Oncology, which are all subjects to an extensive number of innovative drug candidates. This extensive 380+ 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.

Melanoma drug development has and will continue to have a strong focus on target therapy such as vaccines, monoclonal antibodies, dendritic cells, and gene therapy. In recent years, immunologic strategies including tumor vaccine and adjuvant therapy with interferon-alfa have been attempted to improve survival of patients with more advanced malignant melanoma. Another emerging strategy in anticancer therapy is the targeting of chemotherapy resistance by overcoming the antiapoptosis mechanisms of cancer cells.

Melanoma Highlights:
  • Disease overview, including incidence, unmet needs, risk factors, screening and diagnosis.
  • Analysis of current treatment and key therapeutic strategies, including surgery, immunotherapy, vaccines and combination therapies.
  • Includes product profiles of key drugs by class.
  • Progress analysis of on more than 55 pipeline products, including emerging and hot pre-clinical data, discontinued projects, clinical trial information, commercial potential and limiting factors.
Competitive landscape analysis, including extensive lay-out of competitors with collaborations, licensing, M&A etc, major highlights, trends and company profiles on more than 50 of the most important companies in melanoma.

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 in Oncology 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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