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 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


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


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


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


ADX40 90

ImmunoBodies 91

APC targeting mAb-vaccines 92

Vaccibodies 93

ApoVax 96

Ii Key Hybrid 96


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


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


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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Nicolas Bombourg


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