Abstract
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
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? 50
- 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 BiotypeRvector
- 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
- 15.3 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
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
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
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
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