Drug Delivery Technology: Developing a New Generation of Vaccines
Developing a New Generation of Vaccines
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| “Over the past year, excitement within the industry has been growing as companies start to recognize the potential of vaccines.New i nsights into immunobiology and delivery systems may allow the development of better vaccines and vaccines for a wider range of diseases than was previously possible. The market looks set to explode over the next 5-10 years as a raft of new products based on these new technologies are developed and launched.” Dr Sara Sleigh Vaccination is recognized as a cost-effective medical strategy. Vaccines, alongside antibiotics and improved hygiene standards, have been responsible for a steady decrease in morbidity and mortality from infectious diseases worldwide since their introduction early in the 20th century. Currently available vaccines prevent up to 3 million deaths each year and 750,000 children avoid serious disability. Despite this high level of success, almost 7 million children under 5 years old still die each year from infections. Conventional vaccines have been based on live attenuated, or killed, viruses or bacteria, or recombinant proteins from these organisms. The design of live attenuated vaccines depended to some extent on serendipity and resulted in low success rates; both live attenuated and killed vaccines require handling live pathogens and are associated with safety problems. Vaccines based on recombinant protein antigens are not highly immunogenic, proteins can be difficult to manufacture and may have stability issues. Recent scientific advances have increased our understanding of immunobiology and now allow the more rational design of vaccines. These advances include new delivery technologies that will improve the safety and immunogenicity of traditional vaccines as well as introducing entirely new methods of vaccine delivery such as DNA vaccines. It is largely through the development of new delivery methods that companies are now aiming to tackle infectious diseases that have evaded vaccine manufacture in the past, develop vaccines for potential diseases related to bioterrorism and launch the new category of therapeutic vaccines. Vaccines are a vibrant area of pharmaceutical development. The activity in the marketplace has grown steadily over the past few years and looks set to continue and increase in the near future. This report describes the role of new delivery technologies in this rapidly growing field. |
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| Keywords: adenovirus vectors, adjuvants, bacterial delivery methods, biodefense vaccines, cellular immune response, DNA vaccines, emulsions, humoral immune response, non-viral vectors, viral vectors | |
 
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By Dr Sara Sleigh / Publication Date: 23rd November 2007
Contents:
1 The vaccine market: opportunities for novel delivery technologies 6
1.1 Introduction 6
1.2 Overview of the market 7
1.2.1 Market size 7
1.2.2 Key pharma players 8
1.2.3 Key areas of vaccine development 9
1.3 Product pipeline 11
2 Market drivers and opportunities for vaccine delivery technologies 13
3 Leading vaccine delivery companie 15
4 Immune potentiators and adjuvants 18
4.1 Immune potentiators 19
4.1.1 Pattern recognition receptors 19
4.1.2 Case Study: VaxImmuneTM (Coley Pharmaceuticals 23
4.1.3 Host-derived immune potentiators 24
4.1.4 Case study: Oncophage® (Antigenics 4
4.1.5 Case study: ImmuFACTTM (Immutep 5
4.2 Adjuvant delivery systems 6
4.2.1 Alum 6
4.2.2 Emulsions 26
4.2.3 Case study: Stimulon® (Antigenics26
4.2.4 Iscoms (immunostimulating complexes 27
4.2.5 Liposomes 27
4.2.6 Virosomes 27
4.2.7 Virus-like particles (VLPs 8
4.2.8 Case study: VLPs in therapeutic vaccines (Cytos Biotechnology 9
4.2.9 Microparticles/nanoparticles 30
4.3 Our opinion on adjuvant technologies 32
5 Delivering DNA vaccines 33
5.1 Viral delivery methods 33
5.1.1 Adenovirus vectors34
5.1.2 Case study: AdVac® (Crucell 35
5.1.3 Poxvirus vectors 36
5.1.4 Case study: TroVax® (Oxford BioMedica 38
5.1.5 Alphavirus vectors 38
5.1.6 Adeno-associated virus 39
5.1.7 Other viral vectors 39
5.1.8 Case study: ChimeriVaxTM (Sanofi Pasteur40
5.1.9 Case study: ImmunoVEX® (BioVex 41
5.2 Bacterial delivery methods 41
5.3 Complexed DNA 42
5.3.1 Case Study: cationic lipid delivery system VaxfectinTM (Vical Inc 42
5.4 Delivery of uncomplexed DNA 43
5.4.1 Case study: TriGridTM Delivery System (Ichor Medical Systems 45
5.4.2 Case Study: PowderJect technology (PowderMed, part of Pfizer 46
5.5 Our opinion on DNA vaccine delivery technologies 47
6 Vaccine delivery to the mucosal system and skin 48
6.1 Intranasal and inhaled vaccine delivery 48
6.1.1 Case study: polycationic liposomes (NasVax 50
6.1.2 Case study: Modulation of Tight Junction Biology (Alba Therapeutics 50
6.2 Oral vaccine delivery 51
6.2.1 Case study: oral delivery with live bacterial vectors (Avant Immunotherapeutics 53
6.3 Plant-derived vaccines 54
6.4.1 Case study: the PassPortTM Patch (Altea Therapeutics 56
6.5 Our opinion on mucosal and skin delivery technologies 57
7 Needle-free delivery 58
7.1 Liquid jet injectors 58
7.1.1 Case study: Biojector 2000 and VitaVax (Bioject Medical Technologies Inc 59
7.2 Solid dose injectors 60
7.2.1 Case study: Glide Pharmas’ Solid Dose Injector 60
7.3 Our opinion on needle-free delivery technologies 62
8 Single-dose vaccines 63
8.1.1 Case study: OctoVaxTM (OctoPlus 63
8.1.2 Case study: stabilizing vaccines in glass microspheres (Cambridge Biostability 64
9 Market trends in drug delivery in vaccines 65
9.1 Key vaccine delivery companies 65
9.2 Recent partnerships and acquisitions 68
9.3 Market trends 2006-2012 71
9.3.1 Global vaccine delivery market 2006-2012 71
9.3.2 Pharma drivers and vaccine delivery trends by 2012 72
9.4 Market by 2020 73
9.4.1 Global vaccine and vaccine delivery markets by 2020 73
9.4.2 Pharma drivers and vaccine delivery trends by 2020 73
9.5 Summary & Conclusions 75
10 Bibliography 76
11 Acknowledgements 78
List of Tables:
List of Figures:
Figure 1.1: Global vaccine market sales 2006 7
Figure 1.2: Leading vaccine brands 2006 8
Figure 1.3: Leading companies’ vaccine sales (2006 8
Figure 1.4: Key areas of vaccine development 9
Figure 1.5: Numbers of vaccines in clinical development 2006 11
Figure 2.1: Schematic showing simplified mechanisms of humoral and cellular immune response 13
Figure 2.2: Vaccine delivery opportunities 14
Figure 4.1: Pathway of events following TLR9 activation by CpG oligonucleotides 21
Figure 5.1: Oxford BioMedica’s therapeutic cancer vaccine TroVax 38
Figure 5.2: The TriGridTM Delivery System from Ichor Medical Systems 45
Figure 5.3: Schematic diagram of the PowderJect device configured for preclinical use 46
Figure 6.1: Nasal anatomy 48
Figure 6.2: Tight junction biology 51
Figure 6.3: Avant Immnotherapeutic’s live bacterial vaccine vector 53
Figure 6.4: Use of the PassPortTM Patch and Applicator from Altea Therapeutics 56
Figure 7.1: Components of the Biojector 2000 device 59
Figure 7.2: Glide Pharmaceuticals Solid Dose Injector 60
Figure 9.1: Predicted influence of vaccine delivery technologies to 2020 74
List of Tables:
Table 1.1: Anticipated vaccine sales as a percentage of overall pharma sales 2009 2012 for the top 5 companies 9
Table 1.2: Vaccines in clinical development 12
Table 3.1: Leading vaccine delivery companies 15
Table 4.1: Classification of vaccine adjuvants 18
Table 4.2: Pattern-recognition receptors 19
Table 4.3: Toll-like receptor agonists currently in development for
vaccines 20
Table 4.4: Key characteristics of CpG ODNs 22
Table 4.5: Examples of current vaccine development programs with CpG ODNs 23
Table 4.6: Vaccines in development containing host-derived immune potentiators 24
Table 4.7: Virosome-based vaccines in development 28
Table 4.8: Advantages and disadvantages of VLP-based vaccines 28
Table 4.9: VLP-based vaccines for infectious disease 29
Table 4.10: Cytos Biotechnology development pipeline for VLP-based therapeutic vaccines 30
Table 5.1: Advantages and disadvantages of DNA vaccines 33
Table 5.2: Adenovirus-based vaccines in clinical development 35
Table 5.3: Licensees of Crucell’s PER.C6 and AdVac® technology 36
Table 5.4: MVA-based vaccines in development 37
Table 5.5: Alphavax vaccine development programs 39
Table 5.6: Other viral vectors under consideration for vaccine delivery 40
Table 5.7: ChimeriVaxTM products in clinical development 41
Table 5.8: GlobeImmune’s product pipeline 42
Table 5.9: Vaccine candidates under development by Vical and its partners 43
Table 5.10: Companies developing electroporation devices for DNA vaccine delivery 44
Table 5.11: Pipelines of DNA vaccines delivered using electroporation 44
Table 5.12: PowderMed’s vaccine pipeline 46
Table 6.1: Key companies advancing intranasal vaccine delivery 49
Table 6.2: Product pipelines of key companies advancing oral vaccine delivery 52
Table 6.3: Key companies developing vaccines for delivery through the skin 55
Table 6.4: Concealed mini-needle and micro-needle devices 55
Table 7.1: Examples of liquid jet injectors for needle-free vaccine delivery 59
Table 9.1: Summary of leading vaccine delivery companies 65
Table 9.2: Summary of recent alliances, agreements and acquisitions with vaccine delivery companies 69
Table 9.3: Forecasts of approved delivery driven vaccine products 2006-2012 71
Table 9.4: Forecasts of pipeline DD driven vaccine products 2006-2012 (US$ million) 72
Table 9.5: Forecast of vaccine delivery market 2012-2020 (US$ billion) 73