NEW YORK, Nov. 8, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
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 Contents
Innovations 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 Figures
Figure 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 Tables
Table 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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