Therapeutic Vaccines
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope - page 3
- Datamonitor's opinion on the future of the therapeutic vaccines market - page 3
- The early days of the therapeutic vaccine industry have so far been characterized by clinical and commercial failures. This has led to a vicious circle, where a lack of adequate funding and pharmaceutical experience through partnerships, has led to sub-optimal product development, leading to poor clinical results which have further damaged the industry's reputation - page 5
- The first therapeutic vaccines to reach the market have performed poorly. Polyvalent, patient-specific vaccines have major commercial disadvantages that have limited their uptake. However, rapid scientific progress means that antigen-specific, generalized vaccines could soon offer comparable efficacy, to complement their strong commercial profile. As a result, generalized vaccines are now starting to dominate the pipeline - page 7
- Datamonitor believes that there is an increasing trend in therapeutic vaccines development towards the use of multiple antigens (and adjuvants), to attack cancers or HIV from multiple angles-the generally low levels of side effects make this a viable option. Combinations of therapies, and novel approaches such as prime-boost regimens are expected to yield exciting results - page 9
- Because of the increasing focus on combining technologies and vaccines, partnerships will become much more important. The low level of cooperation between vaccine players needs to be addressed in order to accelerate the development of effective vaccines - page 11
- Therapeutic vaccine development is currently heavily weighted towards cancer vaccines, which account for 60.6% of all pipeline projects. However, the early-stage pipeline is starting to show greater interest in other therapeutic areas, from HIV and infectious disease to nicotine addiction, CNS and cardiovascular diseases. - page 12
- CHAPTER 2 STRATEGIC ISSUES IN THE THERAPEUTIC VACCINES INDUSTRY - page 30
- Introduction - page 31
- Factors driving therapeutic vaccine development - page 32
- Unmet clinical needs in cancer and chronic infectious disease - page 32
- Specific examples of unique clinical benefits shown with therapeutic vaccines - page 33
- Low level of side effects - page 34
- Case study - Melacine's side-effect profile was its key advantage - page 34
- Infrequent dosing required because of long-lasting effect - page 35
- Advances in genomics and proteomics enabling improved antigen selection - page 35
- Unmet clinical needs in cancer and chronic infectious disease - page 32
- Scientific issues inhibiting successful development, and how these may be overcome - page 35
- Finding the right antigen or antigens is central to therapeutic vaccine development - page 36
- Well-characterized antigens: an obvious starting point - page 37
- Using genomics and proteomics to generate new antigen targets - page 38
- Delivery technologies - numerous variants, no consensus - page 41
- Adjuvants - a key role in maximizing the immune response, but little commercial interest - page 42
- Older adjuvants - first targeting antibody response, and later T cell response - page 42
- Novel adjuvants - a niche area of R&D - page 43
- Finding the right combination of antigens, delivery method and adjuvant - page 45
- The use of multiple antigens or adjuvants is increasingly popular, encouraged by the low level of side effects - page 45
- Partnerships are the key to creating effective combination products - page 47
- High variability of patient response - page 47
- Targeting the right patient populations - page 48
- Late-stage cancer therapy versus early-stage: when is the optimal time for therapeutic vaccine usage? - page 49
- Mutation of antigens makes a universal immune response difficult with antigen-specific vaccines - page 52
- Finding the right antigen or antigens is central to therapeutic vaccine development - page 36
- Commercial issues inhibiting successful commercialization, and how these may be overcome - page 52
- Some commercial issues are common to both personalized and generalized vaccines... - page 54
- Long clinical trials - page 54
- ...but personalized vaccines present many unique commercial problems - page 54
- High cost, and low scalability of personalized vaccine manufacturing - page 55
- Potential regulatory difficulties - page 57
- Logistical difficulties with collecting and transporting samples and vaccines - page 57
- Lack of acceptance by physicians and the general public - page 58
- Lack of interest from pharmaceutical companies in personalized therapies - page 58
- Lack of funding: the vicious circle - page 59
- Are generalized therapies the answer? - page 60
- In the near term, personalized and generalized vaccines are expected to have similar overall prospects - page 61
- In the longer term, there are clear signs that generalized vaccines are being favored in early-stage development - page 62
- Some commercial issues are common to both personalized and generalized vaccines... - page 54
- Products failing clinical trials - high-profile failures and their causes and effects - page 63
- Aphton's Insegia (G17DT) - no survival benefit - page 63
- CancerVax's Canvaxin - no survival benefit - page 63
- Cell Genesys's GVAX lung and myeloma - commercial limitations of personalized vaccines - page 64
- Progenics' GMK - still in development, but inferiority to interferon alpha severely limits its prospects - page 64
- VaxGen's AIDSVAX - high-profile failure of an HIV vaccine candidate - page 65
- Biomira's Theratope - another vaccine that failed to meet endpoints and improve survival - page 65
- Is big pharma losing interest? - page 65
- Key big pharma players and their partnerships - page 66
- Sanofi Pasteur - page 66
- GlaxoSmithKline - page 68
- Merck & Co - page 69
- Wyeth - page 70
- Merck KGaA - page 70
- Bristol-Myers Squibb - page 70
- Pfizer - page 70
- Roche - page 71
- Key big pharma players and their partnerships - page 66
- Technological advances give hope for the future - page 71
- Polyvalent vaccines - page 72
- Whole cell vaccines - page 73
- Heat shock proteins - page 74
- Antigen-specific vaccines - page 74
- Recombinant viral vector - page 74
- Recombinant bacterial vector - page 75
- Subunit vaccine - page 75
- Peptide vaccine - page 75
- Conjugated vaccines - page 76
- Anti-idiotype vaccines - page 76
- DNA vaccines - page 77
- Prime-boost vaccines - page 77
- Other vaccines - page 78
- Dendritic cell vaccine - page 78
- Toxoid vaccine - page 79
- How can therapeutic vaccines move forward - page 79
- Parallels between the evolution of therapeutic vaccines and monoclonal antibodies - page 80
- Polyvalent vaccines - page 72
- CHAPTER 3 THERAPEUTIC VACCINE MARKET AND PIPELINE ANALYSIS, 2005 - 2010 - page 81
- Current market position, 2005 - page 82
- Profiles of marketed therapeutic vaccines - page 83
- Avax's M-Vax - page 83
- IntraCel's OncoVax - page 84
- Corixa's Melacine (discontinued) - page 84
- Profiles of marketed therapeutic vaccines - page 83
- Pipeline overview - page 85
- Patient-specific versus non-patient-specific vaccines - page 87
- Pipeline analysis according to vaccine type - page 89
- Pipeline analysis according to therapy area - page 92
- Cancer indications being targeted: melanoma is the most common, followed by the 'big four' tumor types and hematological tumors - page 95
- Beyond cancer and infectious disease: emerging therapy areas - page 96
- Sales forecasts - page 97
- Pipeline products from leading companies profiled in Chapter 4 - page 98
- GVAX Prostate - proven survival benefit in prostate cancer makes this Cell Genesys' great hope - page 98
- Provenge - Dendreon's vaccine is the first to achieve survival benefit in Phase III trials for prostate cancer - page 98
- PANVAC/CEA VF-TRICOM - addressing the challenge of pancreatic cancer - page 99
- Oncophage - appears effective only in a small subgroup of melanoma patients - page 99
- MyVax - Genitope leads the race to market an anti-idiotype vaccine for non-Hodgkin's lymphoma - page 99
- Aphton's IGN101 - possible use in various cancers: NSCLC is first but colorectal could eventually provide its biggest success - page 100
- Biovest's BiovaxID - may have lost the chance to be first lymphoma vaccine to market - page 100
- FavID - Favrille looks likely to face stiff competition in the lymphoma marketplace - page 101
- Additional products not covered in company profiles - page 101
- MDX-1379 - Medarex's combination therapy with MDX-010 could be a breakthrough for cancer vaccines - page 101
- GMK vaccine - Progenics - page 102
- AIDSVAX - VaxGen - page 103
- Pipeline products from leading companies profiled in Chapter 4 - page 98
- Current market position, 2005 - page 82
- CHAPTER 4 PROFILES OF LEADING COMPANIES - page 105
- Antigenics - page 106
- Summary - page 106
- SWOT analysis - page 107
- Alliance network - page 107
- Technology platforms - page 109
- Heat Shock Protein technology - page 109
- Liposome encapsulation - page 110
- QS-21 adjuvant - page 110
- Therapeutic vaccines pipeline - page 110
- Oncophage (vitespen; formerly HSPPC-96) - page 110
- AG-858 (HSPPC-70) - page 112
- AG-707 - page 112
- Financial outlook - page 112
- Other activities beyond therapeutic vaccines - page 112
- Aphton - page 113
- Summary - page 113
- SWOT analysis - page 114
- Key events in 2005 - page 114
- Alliance network - page 114
- Technology platforms - page 115
- Anti-gastrin technology - page 115
- Therapeutic vaccines pipeline - page 116
- Insegia (G17DT immunogen) - page 116
- IGN101 - page 117
- GnRH Pharmaccine - page 118
- Financial outlook - page 118
- Other activities beyond therapeutic vaccines - page 119
- Biomira - page 119
- Summary - page 119
- SWOT analysis - page 120
- Alliance network - page 121
- Technology platforms - page 121
- Liposome Vaccine platform - page 122
- Therapeutic vaccines pipeline - page 122
- L-BLP25 - page 123
- Theratope (development suspended) - page 124
- L-BGLP40 - page 124
- Financial outlook - page 125
- Other activities beyond therapeutic vaccines - page 125
- Biovest International - page 125
- Key findings - page 126
- SWOT analysis - page 126
- Alliance network - page 127
- Technology platforms - page 127
- BiovaxID Technology Platform - page 127
- Therapeutic vaccines pipeline - page 128
- BiovaxID - page 128
- Financial outlook - page 129
- CancerVax - page 130
- Summary - page 130
- SWOT analysis - page 131
- Alliance network - page 131
- Technology platforms - page 132
- Therapeutic vaccines pipeline - page 132
- Canvaxin (suspended) - page 132
- SAI-EGF - page 133
- Preclinical programs: SAI-TGF-alpha and SAI-EGFR-ECD - page 133
- Financial outlook - page 134
- Other activities beyond therapeutic vaccines - page 134
- Cell Genesys - page 135
- Key findings - page 135
- SWOT analysis - page 136
- Alliance network - page 136
- Technology platforms - page 137
- GVAX Technology Platform - page 137
- Therapeutic vaccines pipeline - page 137
- GVAX Prostate - page 138
- GVAX Pancreatic - page 138
- GVAX Leukemia - page 139
- Financial outlook - page 139
- Cytos Biotechnology - page 140
- Summary - page 140
- SWOT analysis - page 141
- Alliance network - page 142
- Technology platforms - page 142
- Immunodrugs platform - page 142
- DELphi protein discovery technology - page 143
- pCytTS mammalian expression system - page 143
- Therapeutic vaccines pipeline - page 144
- CYT002-NicQb - page 145
- CYT005-AllQbG10 - page 146
- CYT004-MelQbG10 - page 146
- CYT007-TNFQb - page 146
- CYT006-AngQb - page 147
- CYT009-GhrQb - page 147
- CAD-106 - page 147
- Preclinical products - page 147
- Financial outlook - page 148
- Other activities beyond therapeutic vaccines - page 148
- Dendreon - page 149
- Summary - page 149
- SWOT analysis - page 150
- Alliance network - page 150
- Technology platforms - page 151
- Antigen Delivery Cassette technology - page 151
- Therapeutic vaccines pipeline - page 152
- Provenge (sipuleucel-T) - page 152
- APC8024 (lapuleucel-T) - page 155
- Financial outlook - page 155
- Other activities beyond therapeutic vaccines - page 156
- Favrille - page 156
- Key findings - page 156
- SWOT analysis - page 157
- Alliance network - page 157
- Technology platforms - page 158
- FavID Platform - page 158
- Therapeutic vaccines pipeline - page 158
- FavID - page 159
- Financial outlook - page 159
- Genitope - page 160
- Summary - page 160
- SWOT analysis - page 161
- Alliance network - page 161
- Technology platforms - page 162
- Hi-GET technology - page 162
- Therapeutic vaccines pipeline - page 163
- MyVax Personalized Immunotherapy (GTOP-99) - page 163
- Financial outlook - page 164
- Other activities beyond therapeutic vaccines - page 165
- IDM Pharma - page 165
- Key findings - page 165
- SWOT analysis - page 166
- Alliance network - page 166
- Technology platforms - page 167
- Dendritophage Vaccine Platform - page 167
- DNA Vaccine Platform - page 167
- Free Peptide Vaccine Platform - page 168
- Therapeutic vaccines pipeline - page 169
- EP-2101 - page 169
- Uvidem - page 169
- Collidem - page 170
- EP HIV-1090 - page 170
- Financial outlook - page 170
- Oxxon Therapeutics - page 171
- Key findings - page 171
- SWOT analysis - page 172
- Alliance network - page 172
- Technology platforms - page 173
- PrimeBoost Technology Platform - page 173
- Therapeutic vaccines pipeline - page 173
- HBV 1, HBV 2 - page 174
- Mel 1, Mel 2 - page 174
- HIV 1 - page 174
- Financial outlook - page 175
- Pharmexa - page 175
- Summary - page 176
- SWOT analysis - page 176
- Alliance network - page 177
- Technology platforms - page 179
- AutoVac platform - page 179
- Therapeutic vaccines pipeline - page 180
- GV1001 - page 181
- HER-2 Protein Autovac - page 182
- HER-2 DNA Autovac - page 183
- RANKL vaccine - page 183
- TNF-alpha vaccine - page 183
- AutoVac Alzheimer's vaccine - page 183
- Financial outlook - page 184
- Stressgen Biotechnologies - page 185
- Summary - page 185
- SWOT analysis - page 186
- Alliance network - page 186
- Technology platforms - page 187
- CoVal Fusion Protein technology - page 187
- Therapeutic vaccines pipeline - page 187
- HspE7 - page 188
- Financial outlook - page 188
- Other activities beyond therapeutic vaccines - page 189
- Therion Biologics - page 189
- Key findings - page 190
- SWOT analysis - page 190
- Alliance network - page 191
- Technology platforms - page 191
- Recombinant Viral Vector Platform - page 191
- Therapeutic vaccines pipeline - page 192
- PANVAC-VF - page 193
- PROSTVAC-VF - page 193
- Financial outlook - page 193
- Transgene - page 194
- Key findings - page 194
- SWOT analysis - page 195
- Alliance network - page 195
- Technology platforms - page 196
- Recombinant Viral Vector Platform - page 196
- Therapeutic vaccines pipeline - page 197
- MVA-MUC1-IL2 - page 197
- MVA-HPV-IL2 - page 197
- MVA-HCV - page 198
- Ad-TFN( - page 198
- Financial outlook - page 198
- Antigenics - page 106
- CHAPTER 5 APPENDIX - page 200
- Supplementary data - page 200
- How to contact experts in your industry - page 202
- List of Tables
- Table 1: Cancer antigens most frequently targeted by pipeline cancer vaccines - page 37
- Table 2: Selected antigen licensing deals - page 41
- Table 3: Commercial factors influencing the successful development and commercialization of therapeutic vaccines - page 53
- Table 4: Three major classes of therapeutic vaccine and the technology types included under each class - page 72
- Table 5: Marketed therapeutic vaccine products - page 82
- Table 6: Distribution of therapeutic vaccine pipeline projects by stage of development - page 86
- Table 7: The percentage of pipeline products that are patient-specific decreases sharply in earlier-stage development - page 88
- Table 8: Forecast sales of therapeutic vaccine product candidates in Phase III trials, 2005 - page 97
- Table 9: Antigenics: Key information - page 106
- Table 10: Antigenics' Heat Shock Protein technology - page 109
- Table 11: Antigenics' therapeutic vaccines pipeline, 2005 - page 110
- Table 12: Aphton: Key information - page 113
- Table 13: Aphton's Anti-gastrin technology - page 115
- Table 14: Aphton's therapeutic vaccines pipeline, 2005 - page 116
- Table 15: Biomira: Key information - page 119
- Table 16: Biomira's Liposome Vaccine platform - page 122
- Table 17: Biomira's therapeutic vaccines pipeline, 2005 - page 122
- Table 18: Biovest International: Key information - page 125
- Table 19: BiovaxID Technology Platform - page 127
- Table 20: Biovest's therapeutic vaccines pipeline, 2005 - page 128
- Table 21: CancerVax: Key information - page 130
- Table 22: CancerVax's therapeutic vaccines pipeline, 2005 - page 132
- Table 23: Cell Genesys: Key information - page 135
- Table 24: GVAX Technology Platform - page 137
- Table 25: Cell Genesys' therapeutic vaccines pipeline, 2005 - page 137
- Table 26: Cytos Biotechnology: Key information - page 140
- Table 27: Cytos Biotechnology's Immunodrugs platform - page 142
- Table 28: Cytos Biotechnology's therapeutic vaccines clinical pipeline, 2005 - page 144
- Table 29: Dendreon: Key information - page 149
- Table 30: Dendreon's Antigen Delivery Cassette technology - page 151
- Table 31: Dendreon's therapeutic vaccines pipeline, 2005 - page 152
- Table 32: Favrille: Key information - page 156
- Table 33: FavID Technology Platform - page 158
- Table 34: Favrille's therapeutic vaccines pipeline, 2005 - page 158
- Table 35: Genitope: Key information - page 160
- Table 36: Genitope's Hi-GET technology - page 162
- Table 37: Genitope's therapeutic vaccines pipeline, 2005 - page 163
- Table 38: IDM Pharma: Key information - page 165
- Table 39: Dendritophage Vaccine Platform - page 167
- Table 40: DNA Vaccine Platform - page 167
- Table 41: Free Peptide Vaccine Platform - page 168
- Table 42: IDM Pharma's therapeutic vaccines pipeline, 2005 - page 169
- Table 43: Oxxon Therapeutics: Key information - page 171
- Table 44: PrimeBoost Technology Platform - page 173
- Table 45: Oxxon Therapeutics' therapeutic vaccines pipeline, 2005 - page 173
- Table 46: Pharmexa: Key information - page 175
- Table 47: Pharmexa's AutoVac platform - page 179
- Table 48: Pharmexa's therapeutic vaccines pipeline, 2005 - page 180
- Table 49: Stressgen Biotechnologies: Key information - page 185
- Table 50: Stressgen's CoVal Fusion Protein technology - page 187
- Table 51: Stressgen's therapeutic vaccines pipeline, 2005 - page 187
- Table 52: Therion Biologics: Key information - page 189
- Table 53: Recombinant Viral Vector Platform - page 191
- Table 54: Therion Biologics' therapeutic vaccines pipeline, 2005 - page 192
- Table 55: Transgene: Key information - page 194
- Table 56: Recombinant Viral Vector Platform - page 196
- Table 57: Transgene's therapeutic vaccines pipeline, 2005 - page 197
- Table 58: Numbers of products in development within each technology type - page 200
- Table 59: Numbers of pipeline products in each stage of development, split by therapy area - page 201
- List of Figures
- Figure 1: Lack of funding causes a vicious circle in therapeutic vaccine development - page 6
- Figure 2: Generalized vaccines dominate the early-stage pipeline - page 8
- Figure 3: The overwhelming majority (67.8%) of active pipeline therapeutic vaccines are antigen-specific - page 9
- Figure 4: Therapeutic vaccines technology evolution - page 10
- Figure 5: Cancer vaccines dominate the therapeutic vaccines pipeline, followed by infectious disease and HIV vaccines - page 12
- Figure 6: The clinical-stage therapeutic vaccines pipeline is heavily focused on cancer products, but preclinical products are much more widely distributed among other therapeutic areas - page 13
- Figure 7: Technological evolution of immunotherapeutic medicines - page 31
- Figure 8: The overwhelming majority (67.8%) of active pipeline therapeutic vaccines are antigen-specific - page 36
- Figure 9: Lack of funding causes a vicious circle in therapeutic vaccine development - page 60
- Figure 10: Generalized vaccines are forecast slightly stronger sales growth than personalized vaccines up to 2010 - page 61
- Figure 11: Analysis of the therapeutic vaccines pipeline suggests that generalized therapies are becoming more popular - page 62
- Figure 12: Therapeutic vaccines technology evolution - page 71
- Figure 13: The therapeutic vaccine pipeline shows strong progression up to Phase II but a very low success rate from Phase II onwards - page 86
- Figure 14: Generalized vaccines dominate the early-stage pipeline - page 88
- Figure 15: The overwhelming majority (67.8%) of active pipeline therapeutic vaccines are antigen-specific - page 90
- Figure 16: Analysis of products in development shows that conjugated, dendritic cell and viral vector vaccines are most popular - page 91
- Figure 17: Cancer vaccines dominate the therapeutic vaccines pipeline, followed by infectious disease and HIV vaccines - page 92
- Figure 18: Cancer is the overwhelmingly dominant therapy area by numbers of therapeutic vaccines in development - page 93
- Figure 19: The clinical-stage therapeutic vaccines pipeline is heavily focused on cancer products, but preclinical products are much more widely distributed among other therapeutic areas - page 94
- Figure 20: Late-stage cancer vaccines are largely focused on melanoma, colorectal, prostate, lung and hematological cancers - page 95
- Figure 21: Assessment of Antigenics' strategic position - page 107
- Figure 22: Antigenics' alliance network - page 108
- Figure 23: Assessment of Aphton's strategic position - page 114
- Figure 24: Assessment of Biomira's strategic position - page 120
- Figure 25: Assessment of Biovest International's strategic position - page 126
- Figure 26: Assessment of CancerVax's strategic position - page 131
- Figure 27: Assessment of Cell Genesys' strategic position - page 136
- Figure 28: Assessment of Cytos Biotechnology's strategic position - page 141
- Figure 29: Assessment of Dendreon's strategic position - page 150
- Figure 30: Assessment of Favrille's strategic position - page 157
- Figure 31: Assessment of Genitope's strategic position - page 161
- Figure 32: Assessment of IDM Pharma's strategic position - page 166
- Figure 33: Assessment of Oxxon Therapeutics' strategic position - page 172
- Figure 34: Assessment of Pharmexa's strategic position - page 177
- Figure 35: Pharmexa's alliance network - page 178
- Figure 36: Assessment of Stressgen's strategic position - page 186
- Figure 37: Assessment of Therion Biologics' strategic position - page 190
- Figure 38: Assessment of Transgene's strategic position - page 195
Other users found this report page using the following search terms: therapeutic vaccines immunotherapy vaccines therapeutic rate marketed shock growth setback success swot therapy
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.