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Innovations and Opportunities in Therapeutic Vaccines: Technology Platforms, Key Players, and Early Pipeline Candidates

NEW YORK, Nov. 8, 2010 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Innovations and Opportunities in Therapeutic Vaccines: Technology platforms, key players, and early pipeline candidates

Therapeutic vaccines promise a new wave of highly potent and highly specific therapeutic agents designed to work in harmony with patients' own immune systems. Recent advances in the understanding of the human immune system and in technical capabilities have allowed vaccines to move beyond pre-emptive (prophylactic) immunization and into treatment of established diseases. In April 2010, Dendreon's Provenge became the first ever cancer vaccine to be approved by the US Food and Drug Administration (FDA), overcoming skepticism in the investment community and paving the way for a new generation of biological therapies.

This report explains what therapeutic vaccines are, how they work, and why drug developers around the world are using this approach to address everything from allergies to literally every kind of cancer. More than 70 new proprietary technologies are named and explained, with details of licensing deals and intellectual property positions.

The newest wave of drug candidates based on these technologies can be seen in more than 130 early pipeline candidates, each based on a commercial company or research institute known to have carried out preclinical and/or Phase I trials of at least one therapeutic vaccine candidate in the past year. By way of background, later stage candidates being developed by the same companies are also discussed. In total, more than 270 therapeutic vaccine candidates are identified in this report. Finally, prospects and challenges for the future of this field are discussed, with opinions from around 20 prominent industry leaders and academic researchers.

Key features of this report

  • 'Beginners guide' to vaccines and the human immune system, illustrated with original full-color diagrams, to show the potential challenges and benefits of therapeutic vaccination.
  • More than 70 descriptions of proprietary technologies currently in use around the world to design, produce and administer therapeutic vaccines.
  • A comprehensive guide to companies around the world that are currently developing brand new therapeutic vaccines (i.e. candidates in preclinical or Phase I clinical trials).
  • Details of more than 270 specific vaccine candidates, in development by around 120 different companies and research institutes.
  • Expert opinions on the opportunities, challenges and future trends in the therapeutic vaccine field from around 20 industry leaders and academic researchers, over a dozen of whom were contacted directly and interviewed for this report.

  • Scope of this report

  • Understand the basic qualities of vaccines and how these qualities translate into unique medical and commercial features for therapeutic candidates.
  • Appreciate the challenges and risks of therapeutic vaccines, as well as their promise.
  • Assess emerging technologies for possible investment or in-licensing.
  • Identify which companies are involved in this field, and what they are doing.
  • Predict the kinds of drug that may reach the market over the next ten years.
  • Tailor your own company's strategies to take advantage of upcoming opportunities, such as the validation of new technologies in human patients.

  • Key Market Issues

  • Therapeutic vaccines hold the potential to address diseases with a high unmet need for effective, i.e. markets that are currently under-penetrated.
  • Much like monoclonal antibodies, the inherent specificity of vaccines may shorten drug development times and increase rates of success in preclinical and clinical trials, now that the intricacies of the human immune system are better understood.
  • The recent US approval of Dendreon's personalized cancer vaccine Provenge has established a precedent and a recognized path to regulatory approval for therapeutic vaccines.
  • Newer technologies target the same basic immune system processes as Provenge, but may result in cheaper and more broadly applicable therapies.

  • Key findings from this report

  • New technical capabilities and better understanding of the human immune system has recently allowed vaccination approaches to be applied to therapeutic settings as well as prophylaxis.
  • Demand for therapeutic vaccines is high, and profits from launched drugs are expected to achieve 'blockbuster' levels (billions of US dollars per annum).
  • Treatment of established diseases requires different immune reactions to protective (prophylactic) immunity, to overcome existing disease burdens and immuno-avoidance mechanisms, so immune responses must be 'modulated' rather than just stimulated.
  • Many new candidates use multiple 'antigen' targets, or multiple variants of a single target, to address heterogeneity in both disease targets and patients' immune systems.
  • Vaccine approaches can also be used to inhibit immune responses to specific 'antigens', making them useful for treating allergies, autoimmune diseases and transplant rejection.
  • Various vectors (carriers) and adjuvants (immunostimulators), each with their own benefits and drawbacks, are being used to enhance the delivery of vaccine antigens to target immune cells and to modulate the strength and type of immune responses that result.

  • Key questions answered

  • What are therapeutic vaccines, and what can they do?
  • Why are so many companies and research institutes working on therapeutic vaccines?
  • Which companies are currently working to validate and develop the latest generation of drug candidates based on therapeutic vaccines?
  • What technological and regulatory challenges face these companies in developing such candidates and bringing them to market?
  • What technologies are being used to design, produce and administer these drug candidates?
  • Who developed these technologies, and who is using them right now?

  • Table of ContentsInnovations and Opportunities in Therapeutic Vaccines

    Executive summary 12

    An introduction to therapeutic vaccines 12

    Vaccines comprising unlinked polypeptide antigens 12

    Peptide antigens linked to polypeptide carrier/adjuvant molecules 14

    Delivery of peptide antigens using particulate carriers 14

    DNA vaccines 15

    Recombinant viruses as vaccines 16

    Cell-based vaccines 17

    Chapter 1 An introduction to therapeutic vaccines 20

    Summary 20

    Introduction 21

    Vaccination 21

    Therapeutic vaccination 22

    Specificity 22

    Potency 23

    Convenience and cost 23

    Challenges for therapeutic vaccines 24

    Disease burden 24

    Immunosuppression 24

    Immuno-avoidance 26

    Examples of therapeutic vaccines already approved for sale/manufacture 27

    Rabies vaccines 27

    Allergy vaccines 27

    Alutard SQ 28

    Grazax 28

    Chanllergen 28

    Multiple sclerosis immunotherapy 29

    BCG vaccines as immunotherapies for cancers 29

    TheraCys 30

    OncoTICE 30

    PACIS 30

    Vaccines containing cancer antigens 30

    Melacine 31

    MVax 32

    CreaVax-RCC 32

    Oncophage 33

    Provenge 33

    OncoVAX 35

    Conclusions 35

    Chapter 2 Vaccines comprising unlinked polypeptide antigens 38

    Summary 38

    Introduction 39

    Technology platforms 41

    Polyvalent Vaccines 42

    Tolerogenic vaccines 42

    Apitopes 43

    ToleroMune 44

    Tregitopes 44

    Complementary peptides 45

    Bionor Immuno peptide design 47

    TUMAPs 47

    magnICON 49

    ImmuNovo platforms 49

    PepTcell epitope prediction 50

    Variosite 51

    Optimized cryptic peptides 51

    iAPA 52

    Early pipeline vaccine candidates 53

    ALK-Abello 53

    Apitope 54

    Axon Neuroscience 55

    Bayer Innovation 55

    BioArctic Neuroscience 57

    Bionor Immuno 57

    BioSidus 58

    CIGB 58

    Circassia 58

    CSL 59

    CuraVac 59

    EpiVax 60

    Genovax 60

    Green Peptide 61

    GSK 62

    Helicure 62

    iBio 62

    Immatics 63

    ImmunoCellular Therapeutics 64

    Immunotope 65

    Immunovaccine 65

    ImmunoVentis 66

    ImmuNovo 67

    Intercell 68

    Juvaris 69

    MabVax 69

    Multimmune 69

    OncoTherapy Science 70

    Paladin Labs 71

    PepTcell 71

    Pfizer 71

    Profectus 72

    PSMA Development Co 73

    Shionogi 73

    Variation Biotech 73

    Vaxine Pty Ltd 74

    Vaxon 75

    VaxOnco 76

    Conclusions 83

    Antigenicity 83

    Target antigen(s) 83

    Tolerance 84

    Production 84

    Chapter 3 Peptide antigens linked to polypeptide carrier/adjuvant molecules 88

    Summary 88

    Introduction 89

    Technology platforms 89

    Haptenization 89

    Mimotopes 89

    AFFiTOME 90

    ADX40 90

    ImmunoBodies 91

    APC targeting mAb-vaccines 92

    Vaccibodies 93

    ApoVax 96

    Ii Key Hybrid 96

    LEAPS 98

    HSP technology 98

    ASIT+ 99

    CyaA 99

    ImmuCcine 100

    Kinoid vaccines 100

    UBITh 101

    Early pipeline vaccine candidates 101

    AFFiRiS 101

    Antigen Express 102

    Antigenics 102

    ApoImmune 103

    Araclon Biotech 103

    Aster Biopharmaceuticals 104

    BioTech Tools 104

    Braasch Biotech 104

    Cancer Research UK 106

    CEL-SCI 106

    Celldex 106

    Genticel 107

    GSK 108

    Immunotech Labs 109

    Immunovative Therapies 109

    Kancer Ltd 110

    Neovacs 110

    Pfizer 111

    Pro-Cure 112

    Recopharma 113

    SJ Biomed 113

    UBI 114

    Vaccibody AS 116

    Conclusions 119

    Chapter 4 Delivery of peptide antigens using particulate carriers 122

    Summary 122

    Introduction 123

    Technology platforms 123

    SupraAntigen 123

    ImuXen 124

    Lipotek platforms 124

    Virosomes 124

    Virus-like particles 125

    CVLPs 125

    HCV VLPs 126

    Schiller and Chackerian 126

    Auto-antibody drugs 127

    Immunodrugs 127

    WHcAg VLPs 128

    PREPs 128

    Versamune 129

    CHP Technology 130

    DCtag 130

    pMHC-NP 131

    Cellarium 132

    Early pipeline vaccine candidates 132

    AC Immune 132

    C-Pharma 133

    Cytos 134

    Dendright 134

    Henderson Morely 135

    ImmunoFrontier 136

    InCytu 137

    Lentigen 137

    Lipotek 137

    Lipoxen 138

    Oncothyreon 138

    Panvax 139

    Parvus Therapeutics 139

    PDS Biotech 140

    Pevion 141

    Select Vaccines 142

    VLP Biotech 142

    Conclusions 145

    Chapter 5 DNA vaccines 148

    Summary 148

    Introduction 149

    Technology platforms 150

    Ii suppression 150

    BHT-DNA 151

    ANTIGENeering 151

    Peptide-Derivatized Dendrimers 152

    IL-12M 153

    TriGrid 154

    LAMP-vax 154

    SynCon 155

    ProfectusVAX 156

    ImuXen 156

    Early pipeline vaccine candidates 157

    Antigen Express 157

    Bayhill Therapeutics 157

    CIGB 158

    Genetic Immunity 158

    Genexine 159

    Genovax 159

    GeoVax 160

    Ichor 161

    ImmunoFrontier 162

    ImmunoGenetix 162

    Immunomic Therapeutics 163

    Inovio 164

    Karolinska Institute 165

    Lipoxen 165

    Merck & Co 166

    Profectus 167

    Scancell 167

    University of Miami 168

    University of Southampton 169

    Vaccibody AS 169

    Vical 169

    ViroMed 170

    Conclusions 173

    Chapter 6 Recombinant viruses as vaccines 178

    Summary 178

    Introduction 179

    Technology platforms 179

    Alphavaccine 179

    MVA-BN 180

    Chimpanzee adenovirus vectors 180

    Theravax 182

    Co-X-Gene 182

    ProfectusVAX 182

    IBDV 183

    Early pipeline vaccine candidates 183

    AlphaVax 183

    BN ImmunoTherapeutics 184

    Crucell 185

    Genexine 186

    GenPhar 186

    GeoVax 186

    Okairos 187

    Profectus 188

    PSMA Development Co 188

    Transgene SA 188

    TSD Japan 189

    Vaxin Inc 190

    VectorLogics 190

    Virax 191

    Conclusions 195

    Safety concerns 195

    Immunogenicity 196

    Chapter 7 Cell-based vaccines 198

    Summary 198

    Introduction 199

    Technology platforms 199

    Advaxis' Listeria platform 199

    Aduro BioTech's Listeria platforms 200

    AEterna Zentaris bacterial carrier system 201

    Tarmogens 201

    Autologous dendritic cells 203

    iAPA 204

    DCVax 204

    HS System 205

    HyperAcute Immunotherapies 206

    TGF-? antisense technology 207

    ImmuneFx 207

    OPALs 209

    Early pipeline vaccine candidates 209

    Aduro BioTech 209

    Advaxis 210

    AEterna Zentaris 210

    Cadila Pharmaceuticals 210

    Celprogen 211

    Creagene 211

    Dendreon 211

    Entest 212

    Geron 213

    GlobeImmune 214

    Gradalis 216

    Heat Biologics 217

    ImmunoCellular Therapeutics 217

    ImmunoVentis 218

    King's College, London 219

    Morphogenesis 219

    Multimmune 220

    Newcastle University 220

    NewLink Genetics 221

    Northwest Biotherapeutics 222

    NovaRx 223

    OPAL Therapeutics 223

    Pique Therapeutics 224

    University of Queensland 224

    VaxOnco 225

    Conclusions 230

    Microbial cells 230

    Diseased or disease-mimicking cells 230

    Dendritic cell vaccines 231

    The future of therapeutic vaccines 232

    Appendix 233

    Primary research methodology 233

    Glossary 234

    Index 247

    References 255

    List of FiguresFigure 2.1: Antigen presentation by MHC class I 40

    Figure 2.2: Antigen presentation by MHC class II 41

    Figure 2.3: ARM treatment of autoimmune disease 46

    Figure 3.4: Immunobody activation of T-helper cells 92

    Figure 3.5: An example of a Vaccibody 94

    Figure 3.6: An Ii Key Hybrid 97

    Figure 7.7: Tarmogen vaccination 202

    List of TablesTable 2.1: Therapeutic vaccine candidates containing unlinked polypeptide antigens 77

    Table 2.2: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 1) 78

    Table 2.3: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 2) 79

    Table 2.4: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 3) 80

    Table 2.5: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 4) 81

    Table 2.6: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 5) 82

    Table 3.7: Therapeutic vaccine candidates containing peptide antigens linked to polypeptide carriers/adjuvant molecules 117

    Table 3.8: Therapeutic vaccine candidates containing peptide antigens linked to polypeptide carriers/adjuvant molecules (ctd 1) 118

    Table 3.9: Therapeutic vaccine candidates containing peptide antigens linked to polypeptide carriers/adjuvant molecules (ctd 2) 119

    Table 4.10: Therapeutic vaccine candidates using simple particulate carriers 143

    Table 4.11: Therapeutic vaccine candidates using simple particulate carriers (ctd) 144

    Table 5.12: Therapeutic DNA vaccine candidates 171

    Table 5.13: Therapeutic DNA vaccine candidates (ctd 1) 172

    Table 5.14: Therapeutic DNA vaccine candidates (ctd 2) 173

    Table 6.15: Therapeutic vaccine candidates comprising recombinant viruses 193

    Table 6.16: Therapeutic vaccine candidates comprising recombinant viruses (ctd) 194

    Table 7.17: Therapeutic cell-based vaccine candidates 226

    Table 7.18: Therapeutic cell-based vaccine candidates (ctd 1) 227

    Table 7.19: Therapeutic cell-based vaccine candidates (ctd 2) 228

    Table 7.20: Therapeutic cell-based vaccine candidates (ctd 3) 229

    To order this report:Biotechnology Industry: Innovations and Opportunities in Therapeutic Vaccines: Technology platforms, key players, and early pipeline candidates

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