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Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies
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Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies

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IntroductionNo therapeutic cancer vaccine has received approval in any of the seven major pharmaceutical markets, despite extensive research efforts. However, with one product in pre-registration in ...

IntroductionNo therapeutic cancer vaccine has received approval in any of the seven major pharmaceutical markets, despite extensive research efforts. However, with one product in pre-registration in the US, the prospect of the first marketed therapeutic cancer vaccine in the seven major markets is now closer to reality.Scope*Forecast sales of the therapeutic cancer vaccines in late-phase development in the seven major markets over the period 2009 to 2018*In-depth profiles and analysis for all vaccines in late-phase development, including trial data, SWOT analysis and clinical and commercial potential*Segmentation and analysis of the therapeutic cancer vaccine pipeline by developmental phase, class, indication and technology platform*Insight and analysis of market potential for therapeutic cancer vaccines including commercial opportunity, unmet needs and patient potentialHighlightsThe theoretical market potential for therapeutic cancer vaccines in the seven major markets totals over $4.7 billion. Due to the limitations associated with the first generation of cancer vaccines, Datamonitor forecasts the current late-phase therapeutic cancer vaccines to achieve lower sales of $1.3 billion by 2018.High risk and uncertain rewards have limited larger companies' involvement in the therapeutic cancer vaccines. Of the larger companies, GlaxoSmithKline and Merck KGaA have made the greatest commitment. The prospect of the first therapeutic vaccine approval in the US could stimulate renewed interest in this therapy class from further key players.Of the 13 vaccines in late-phase development, Provenge (Dendreon), Stimuvax (Merck KGaA/Oncothyreon) and MAGE-A3 ASCI (GlaxoSmithKline) have the highest clinical and commercial potential. Provenge is likely to be the first therapeutic cancer vaccine to market, having shown a statistically significant overall survival advantage in prostate cancer.Reasons to Purchase*Justify go/no-go decisions on the basis of potential return on investment*Identifying licensing opportunities based on company portfolio and market needs*Use product profiles to aid pricing and reimbursement decisions

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    Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Document Transcript

    • Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of firstapproval set to reinvigorate interest from major companiesPublished on December 2009 Report SummaryIntroductionNo therapeutic cancer vaccine has received approval in any of the seven major pharmaceutical markets, despite extensive researchefforts. However, with one product in pre-registration in the US, the prospect of the first marketed therapeutic cancer vaccine in theseven major markets is now closer to reality.Scope*Forecast sales of the therapeutic cancer vaccines in late-phase development in the seven major markets over the period 2009 to2018*In-depth profiles and analysis for all vaccines in late-phase development, including trial data, SWOT analysis and clinical andcommercial potential*Segmentation and analysis of the therapeutic cancer vaccine pipeline by developmental phase, class, indication and technologyplatform*Insight and analysis of market potential for therapeutic cancer vaccines including commercial opportunity, unmet needs and patientpotentialHighlightsThe theoretical market potential for therapeutic cancer vaccines in the seven major markets totals over $4.7 billion. Due to thelimitations associated with the first generation of cancer vaccines, Datamonitor forecasts the current late-phase therapeutic cancervaccines to achieve lower sales of $1.3 billion by 2018.High risk and uncertain rewards have limited larger companies involvement in the therapeutic cancer vaccines. Of the largercompanies, GlaxoSmithKline and Merck KGaA have made the greatest commitment. The prospect of the first therapeutic vaccineapproval in the US could stimulate renewed interest in this therapy class from further key players.Of the 13 vaccines in late-phase development, Provenge (Dendreon), Stimuvax (Merck KGaA/Oncothyreon) and MAGE-A3 ASCI(GlaxoSmithKline) have the highest clinical and commercial potential. Provenge is likely to be the first therapeutic cancer vaccine tomarket, having shown a statistically significant overall survival advantage in prostate cancer.Reasons to Purchase*Justify go/no-go decisions on the basis of potential return on investment*Identifying licensing opportunities based on company portfolio and market needsPipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 1/12
    • Find Industry reports, Company profilesReportLinker and Market Statistics*Use product profiles to aid pricing and reimbursement decisions Table of ContentOverview 1Catalyst 1Summary 1ABOUT DATAMONITOR HEALTHCARE 2About the Oncology pharmaceutical analysis team 2Executive Summary 3Strategic scoping and focus 3Datamonitor insight into the disease market 4Contributing experts 5Related reports 5Upcoming related reports 6Pipeline Overview and Dynamics 8Key findings 8Pipeline overview 9Pipeline summary 9There are 13 therapeutic cancer vaccines in late-phase clinical development in the seven major markets 9High barriers to commercialization have restricted the number of personalized therapeutic cancer vaccines in clinical development 11Peptide-based vaccines are the most common technology class in the therapeutic cancer vaccines pipeline 12A disproportionately high number of therapeutic cancer vaccines are in development for melanoma 14Comparative forecasts 16Datamonitor forecasts the late-phase therapeutic cancer vaccines to realize sales of $1.3 billion by 2018 16Datamonitor pipeline assessment summary 16Key companies involved in the therapeutic cancer vaccines pipeline 18Analysis of the therapeutic cancer vaccines pipeline by company 18High risk and uncertain rewards have limited Big Pharma involvement in the therapeutic cancer vaccines pipeline 18GlaxoSmithKline has made the greatest commitment to therapeutic cancer vaccines of all the Big Pharma 20Therapeutic cancer vaccine deals and alliances 21There have been relatively few deals and alliances involving therapeutic cancer vaccines in recent years 212. Therapeutic Cancer Vaccines - Market Potential 24Key findings 24Introduction to therapeutic cancer vaccines 25Tumors and the immune system 25There is substantial evidence supporting a link between tumors and the immune system 25Researchers have identified a large number of tumor antigens 25Definition of therapeutic cancer vaccines 26Therapeutic cancer vaccines are defined as active specific immunotherapy 26Classification of therapeutic cancer vaccines 27Evaluation of therapeutic cancer vaccine technology platforms 28Anti-idiotype vaccines 28Antigen-presenting cell (APC) vaccines 29DNA vaccines 30Heat-shock proteins 30Peptide-based vaccine 30Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 2/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsRecombinant protein-based vaccines 31Whole-cell vaccines 31Clinical barriers facing therapeutic cancer vaccine developers 33Factors limiting the efficacy of therapeutic cancer vaccines 33Tumor escape mechanisms allow tumor cells to evade recognition and destruction by the immune system 33Positive outcomes to therapeutic vaccination are less likely in patients with late-stage disease 34Strategies for improving cancer vaccine efficacy 34Combining vaccines with chemotherapy or monoclonal antibodies could help to inhibit tumor escape 34Vaccine adjuvants are commonly used to boost immune responses 36Trials in early-stage patients are likely to be more successful but pose significant challenges 36Unmet needs in cancer 37Therapeutic cancer vaccines have the potential to address several unmet needs in cancer 37Patient potential 39Assessment of therapeutic cancer vaccine patient potential and market potential 393. R&D Approach 41Key findings 41Clinical trial design for therapeutic cancer vaccines: a different approach to oncology R&D 42Patient selection 42Early-stage patients are likely to show better responses to immunotherapy 42Patient cohort homogeneity is particularly important in therapeutic cancer vaccine clinical trials 42Biomarkers could play an important role in patient selection for therapeutic cancer vaccine clinical trials 43Dosing 43Maximum tolerated dose does not determine the optimum dose for therapeutic cancer vaccines 43Endpoints 43Overall survival is the most robust primary endpoint for licensing applications 43Response rates from single-arm Phase II trials do not effectively support go/no-go decisions 44Therapeutic cancer vaccine clinical trials should incorporate immunological endpoints 44Monitoring for autoimmune manifestations is important in therapeutic cancer vaccine clinical trials 45Monitoring for delayed vaccine effects 45Clinical trial designs should take into account the possibility of a delayed immune response 45Co-administered drugs 46Combinations of vaccines with other drug therapies should be evaluated from early- through to late-stage 464. Pipeline Analysis & Forecasts: Personalized Vaccines 47Key findings 47Overview for personalized therapeutic vaccines 48Pipeline summary 48Comparative forecasts 49BiovaxID (Accentia Biopharmaceuticals) 52Drug overview 52Drug profile 52Key historical events 53SWOT analysis 54Clinical trial data 55Phase III study shows that maintenance BiovaxID prolongs disease-free survival in follicular lymphoma 55Phase II data in mantle cell lymphoma show that BiovaxID treatment is feasible in B-cell-depleted patients 56Clinical attractiveness 57BiovaxIDs positive Phase III data represent an important milestone for therapeutic vaccines... 57...but clinical relevance of the data is doubtful 57Commercial attractiveness 58As a personalized vaccine, BiovaxID will have to overcome major economical and logistical barriers 58Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 3/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsRituxan will provide fierce competition for BiovaxID in the first-line maintenance setting 58Forecasts to 2018 58M-Vax (Avax Technologies) 59Drug overview 59Drug profile 59Key historical events 60SWOT analysis 61Clinical trial data 62Clinical attractiveness 63As a personalized vaccine, M-Vax will have to offer significant efficacy advantages over the other vaccines in late-phase developmentfor melanoma 63The toxicity associated with Proleukin could restrict uptake of M-Vax 63Commercial attractiveness 63Fierce competition from standardized therapeutic vaccines in development for melanoma is likely 63Datamonitor drug assessment score card for M-Vax 64Forecasts to 2018 64Oncophage (vitespen; Antigenics) 65Drug overview 65Drug profile 66Key historical events 67SWOT analysis 68Clinical trial data 69Retrospective analysis of Phase III RCC data suggest that Oncophage improves recurrence-free survival in a subgroup of patients 69Clinical attractiveness 70Oncophage is targeting a high unmet need group of patients 70Commercial attractiveness 70Oncophage will struggle to penetrate the more lucrative seven major markets 70Forecasts to 2018 71Provenge (sipuleucel-T; Dendreon) 71Drug overview 71Drug profile 72Key historical events 73SWOT analysis 74Clinical trial data 75Phase III D9901 study shows Provenge to confer a statistically significant improvement in overall survival, however, it failed to meetits primary endpoint of improving time to progression 76Phase III IMPACT study shows Provenge to confer a statistically significant improvement in overall survival, therefore meeting thetrials primary endpoint 77Combined D9901 and D9902A subgroup analysis shows Taxotere administered upon disease progression to Provenge-treatedpatients results in a prolonged survival benefit 78Preliminary results from the PROTECT trial suggest Provenges efficacy in early-stage prostate cancer 78Clinical attractiveness 79Provenge may represent a viable alternative for those patients precluded from Taxotere therapy 79Potential exists for line extension of Provenge into the adjuvant setting 80Commercial attractiveness 80Provenge has already generated considerable controversy 80Provenges probable high cost and complex manufacture may be offset by being the first vaccine to demonstrate a survival benefit inprostate cancer 81The backing of an established oncology player could enhance Provenges commercial potential 81Datamonitor drug assessment score card for Provenge 82Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 4/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsForecasts to 2018 835. Pipeline Analysis & Forecasts: Standardized Vaccines 84Key findings 84Overview for standardized therapeutic vaccines 85Pipeline summary 85Comparative forecasts 87Abagovomab (ACA-125; Menarini/CellControl Biomedical) 90Drug overview 90Drug profile 90Key historical events 91SWOT analysis 92Clinical trial data 93Phase I/II data show that abagovomab induces immune responses and is well tolerated in ovarian cancer 94Clinical attractiveness 96There is considerable doubt surrounding the clinical potential of abagovomab in Stage III/IV ovarian cancer 96Commercial attractiveness 96Menarinis lack of oncology presence could make partnership with a larger oncology player necessary 96First-line maintenance setting could be a relatively lucrative niche population for abagovomab 96Datamonitor drug assessment score card for abagovomab 97Forecasts to 2018 98Allovectin-7 (velimogene aliplasmid; Vical) 98Drug overview 98Drug profile 99Key historical events 100SWOT analysis 101Clinical trial data 102Vical discontinued Phase III development of lower dose Allovectin-7 in metastatic melanoma 102Phase II data for higher dose Allovectin-7 show activity and tolerability in Stage III/IV melanoma 103Clinical attractiveness 103It is uncertain whether high-dose Allovectin-7 will be significantly more effective than low-dose Allovectin-7 103Gene therapy technology likely to generate particular skepticism and caution from physicians 104Intratumoral route of administration will limit Allovectins indication expansion potential 104Commercial attractiveness 104Finding a marketing partner in the US and EU markets could prove challenging for Vical 104Datamonitor drug assessment score card for Allovectin-7 105Forecasts to 2018 106Gp100:209-217(210M) (National Cancer Institute) 106Drug overview 106Drug profile 107Key historical events 107SWOT analysis 108Clinical trial data 109Phase III data show that gp100:209-217(210M) is active in melanoma 109Clinical attractiveness 110Positive Phase III data mark an important milestone for therapeutic cancer vaccines in melanoma... 110...although it is doubtful whether the data are sufficient to support approval at this stage 110The toxicity associated with Proleukin could restrict uptake of gp100:209-217(210M) 110Commercial attractiveness 111Despite positive Phase III data, gp100:209-217(210M) has not yet attracted a partner from industry 111Forecasts to 2018 111Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 5/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsGV-1001 (tertomotide; Kael-GemVax) 111Drug overview 111Drug profile 112Key historical events 113SWOT analysis 114Clinical trial data 115One Phase III study of GV-1001 in pancreatic cancer has been terminated 115Phase I/II data show that GV-1001 plus GM-CSF induces an immune response in unresectable pancreatic cancer 116Phase I/II data in NSCLC point to GV-1001s potential in other indications 117Clinical attractiveness 117PrimoVax Phase III failure highlights the difficulties of sequencing chemotherapy with vaccines 117Commercial attractiveness 117Negative Phase III data could make it difficult to attract a larger partner 117Merck & Co could provide a major competitive threat if its telomerase-based vaccines reach the market 117Datamonitor drug assessment score card for GV-1001 118Forecasts to 2018 119Lucanix (belagenpumatucel-L; NovaRx) 119Drug overview 119Drug profile 120Key historical events 120SWOT analysis 121Clinical trial data 122Clinical attractiveness 123It will be very challenging for Lucanix to show a survival advantage in late-stage NSCLC 123Commercial attractiveness 124Lucanix could face strong competition in the maintenance setting from Alimta 124Datamonitor drug assessment score card for Lucanix 125Forecasts to 2018 126MAGE-A3 ASCI (astuprotimut-r; GlaxoSmithKline) 126Drug overview 126Drug profile 127Key historical events 128SWOT analysis 129Clinical trial data 129Phase II data show non-statistically significant disease-free survival improvement in early-stage non-small cell lung cancer 131Phase II data show that AS15 adjuvant is superior to AS02 adjuvant in melanoma 132Clinical attractiveness 132Early-stage NSCLC could be a favorable setting for MAGE-A3 ASCI 132MAGE-A3 ASCIs tolerability will be an advantage in the maintenance setting for platinum-treated patients 133Potential to select patients most likely to respond to therapy could be a significant advantage 134MAGE-A3 ASCIs potential in melanoma is less certain than in NSCLC 134Commercial attractiveness 134The need for patients to express MAGE-A3 restricts the commercial potential of MAGE-A3 ASCI 134GlaxoSmithKlines experience of both the oncology and vaccines market will give a competitive advantage 134Datamonitor drug assessment score card for MAGE-A3 ASCI 135Forecasts to 2018 136MDX-1379 (Bristol-Myers Squibb) 137Drug overview 137Drug profile 138Key historical events 139Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 6/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsSWOT analysis 140Clinical trial data 141MDX-1379 plus ipilimumab induced a modest percentage of durable response in Stage IV melanoma 141Clinical attractiveness 142Autoimmune events could make the risk: benefit ratio for MDX-1379 plus ipilimumab unfavorable 142Phase II data show limited evidence of MDX-1379s clinical activity... 142...although there is strong proof-of-concept for therapeutic vaccines based on gp100 in melanoma 143Commercial attractiveness 143The combination of two expensive biologics will be unattractive to payers 143Datamonitor drug assessment score card for MDX-1379 144Forecasts to 2018 145PR1 peptide antigen (The Vaccine Company) 145Drug overview 145Drug profile 146Key historical events 147SWOT analysis 148Clinical trial data 149PR1 peptide antigen induced immune and clinical responses in patients with myeloid hematological malignancies in Phase I/II trial150Clinical attractiveness 151PR1 peptide antigen could fulfill the unmet need for more tolerable treatment options in elderly AML patients 151Commercial attractiveness 151PR-1 peptide antigen would benefit from the backing of a more experienced company 151Datamonitor drug assessment score card for PR1 peptide antigen 152Forecasts to 2018 153Stimuvax (BLP-25; Merck KGaA/Oncothyreon) 153Drug overview 153Drug profile 154Key historical events 155SWOT analysis 156Clinical trial data 157Phase II data show that locoregional Stage III non-small cell lung cancer patients may be optimal target patient population forStimuvax 158There is a lack of clinical trial data for Stimuvax in breast cancer 159Clinical attractiveness 159Stimuvax could fill a niche in the NSCLC market 159Stimuvaxs clinical potential in breast cancer is difficult to predict 159Commercial attractiveness 160Merck KGaAs experience in the oncology market will prove valuable for the successful commercialization of Stimuvax 160Datamonitor drug assessment score card for Stimuvax 161Forecasts to 2018 162Bibliography 164APPENDIX 172Methodology 172Product forecasts 172Datamonitor drug assessment scorecard 172About Datamonitor 173About Datamonitor Healthcare 173About the Oncology analysis team 174Datamonitor consulting 174Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 7/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsDisclaimer 174List of TablesTable 1: Therapeutic vaccines in late-phase clinical development (Phase III or pre-registration) for cancer in the seven major markets,2009 10Table 2: Sales forecasts for late-phase pipeline therapeutic cancer vaccines in the seven major markets, 2009-2018 ($m) 16Table 3: Therapeutic cancer vaccines in clinical development by Big Pharma, 2009 20Table 4: Deals and alliances involving therapeutic cancer vaccines in clinical development, 2001-09 22Table 5: Summary advantages and disadvantages associated with the most commonly used technology platforms for the pipelinetherapeutic cancer vaccines, 2008 28Table 6: Unmet needs in selected cancer indications, 2009 37Table 7: Datamonitor assessment of patient potential and market potential ($m) for therapeutic cancer vaccines in selectedindications, 2018 39Table 8: Personalized therapeutic vaccines in late-phase clinical development (Phase III or pre-registration) for cancer in the sevenmajor markets, 2009 48Table 9: Forecast assumptions for personalized therapeutic cancer vaccines in late-phase development in the seven major markets,2009 50Table 10: Sales forecasts for late-phase personalized therapeutic cancer vaccines in the seven major markets, 2009-2018 ($m) 51Table 11: BiovaxID - drug profile, 2009 52Table 12: BiovaxID: key historical events 53Table 13: Clinical development of BiovaxID, 2009 55Table 14: M-Vax - drug profile, 2009 59Table 15: M-Vax: key historical events 60Table 16: M-Vax: clinical development, 2009 62Table 17: Sales forecast for M-Vax in melanoma across the seven major markets, 2009-2018 ($m) 64Table 18: Oncophage - drug profile, 2009 66Table 19: Oncophage: key historical events 67Table 20: Clinical development of Oncophage, 2009 69Table 21: Provenge - drug profile, 2009 72Table 22: Provenge: key historical events 73Table 23: Clinical development of Provenge in prostate cancer, 2009 75Table 24: Sales forecast for Provenge in metastatic castrate-resistant prostate cancer across the seven major markets, 2009-2018($m) 83Table 25: Therapeutic vaccines in late-phase clinical development (Phase III or pre-registration) for cancer in the seven majormarkets, 2009 85Table 26: Forecast assumptions for standardized therapeutic cancer vaccines in late-phase development in the seven major markets,2009 (1of 2) 87Table 27: Forecast assumptions for standardized therapeutic cancer vaccines in late-phase development in the seven major markets,2009 (2 of 2) 88Table 28: Sales forecasts for late-phase standardized therapeutic cancer vaccines in the seven major markets, 2009-2018 ($m) 89Table 29: Abagovomab - drug profile, 2009 90Table 30: Abagovomab: key historical events 91Table 31: Clinical development of abagovomab, 2009 93Table 32: Sales forecast for abagovomab in ovarian cancer across the seven major markets, 2009-2018 ($m) 98Table 33: Allovectin-7 - drug profile, 2009 99Table 34: Allovectin-7: key historical events 100Table 35: Clinical development of Allovectin-7, 2009 102Table 36: Sales forecast for Allovectin-7 in melanoma across the seven major markets, 2009-2018 ($m) 106Table 37: Gp100:209-217(210M) - drug profile, 2009 107Table 38: Gp100:209-217(210M): key historical events 107Table 39: GV-1001 - drug profile, 2009 112Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 8/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsTable 40: GV-1001: key historical events 113Table 41: Clinical development of GV-1001, 2009 115Table 42: Sales forecast for GV-1001 in pancreatic cancer across the seven major markets, 2009-2018 ($m) 119Table 43: Lucanix - drug profile, 2009 120Table 44: Lucanix: key historical events 120Table 45: Clinical development of Lucanix, 2009 122Table 46: Sales forecast for Lucanix in NSCLC across the seven major markets, 2009-2018 ($m) 126Table 47: MAGE-A3 ASCI - drug profile, 2009 127Table 48: MAGE-A3 ASCI: key historical events 128Table 49: Clinical development of MAGE-A3 ASCI, 2009 130Table 50: Sales forecast for MAGE-A3 ASCI in non-small cell lung cancer (NSCLC) across the seven major markets, 2009-2018 ($m)136Table 51: Sales forecast for MAGE-A3 ASCI in melanoma across the seven major markets, 2009-2018 ($m) 136Table 52: Combined sales forecast for MAGE-A3 ASCI (in NSCLC and melanoma) across the seven major markets, 2009-2018 ($m)137Table 53: MDX-1379 - drug profile, 2009 138Table 54: MDX-1379: key historical events 139Table 55: Clinical development of MDX-1379, 2009 141Table 56: Sales forecast for MDX-1379 in melanoma across the seven major markets, 2009-2018 ($m) 145Table 57: PR1 peptide antigen - drug profile, 2009 146Table 58: PR1 peptide antigen: key historical events 147Table 59: Clinical development of PR1 peptide antigen, 2009 149Table 60: Sales forecast for PR1 peptide antigen in acute myeloid leukemia (AML) across the seven major markets, 2009-2018 ($m)153Table 61: Stimuvax - drug profile, 2009 154Table 62: Stimuvax: key historical events 155Table 63: Clinical development of Stimuvax, 2009 157Table 64: Sales forecast for Stimuvax in non-small cell lung cancer (NSCLC) across the seven major markets, 2009-2018 ($m) 162Table 65: Sales forecast for Stimuvax in breast cancer across the seven major markets, 2009-2018 ($m) 162Table 66: Combined sales forecast for Stimuvax (in NSCLC and breast cancer) across the seven major markets, 2009-2018 ($m) 163Table 67: Datamonitor drug assessment parameters 172List of FiguresFigure 1: Number of personalized therapeutic cancer vaccines in clinical development versus number of standardized therapeuticcancer vaccines in clinical development, 2009 11Figure 2: Analysis of the therapeutic cancer vaccines clinical pipeline by class of technology platform, 2009 12Figure 3: Number of therapeutic cancer vaccines in development by indication, 2009 14Figure 4: Datamonitor drug assessment summary for the therapeutic cancer vaccines in late-phase clinical development in the sevenmajor markets, 2009 17Figure 5: Analysis of the therapeutic cancer vaccines pipeline by type of company, 2009 18Figure 6: Classification of tumor antigens most commonly targeted by the therapeutic cancer vaccines, 2009 26Figure 7: Classification of therapeutic cancer vaccines, 2009 27Figure 8: Clinical barriers to successful therapeutic cancer vaccine development and potential solutions 33Figure 9: Datamonitor drug assessment summary for the personalized therapeutic cancer vaccines in late-phase clinical developmentin the seven major markets, 2009 49Figure 10: BiovaxID SWOT analysis, 2009 54Figure 11: BiovaxID: Phase III results as first-line consolidation therapy in follicular lymphoma 56Figure 12: M-Vax SWOT analysis, 2009 61Figure 13: M-Vax: Phase I/II results in Stage IIIb-IV melanoma 62Figure 14: M-Vax - Datamonitor drug assessment summary, 2009 64Figure 15: Oncophage SWOT analysis, 2009 68Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 9/12
    • Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 16: Provenge SWOT analysis, 2009 74Figure 17: Provenge: Phase III D9901 results of investigation in asymptomatic metastatic castration-resistant prostate cancer 76Figure 18: Provenge: Phase III IMPACT results of investigation in asymptomatic or mildly symptomatic metastatic castration-resistantprostate cancer 77Figure 19: Provenge: analysis of patient subgroup from Phase III D9901 and D9902A studies who received Taxotere followingProvenge or placebo 78Figure 20: Provenge: preliminary Phase III PROTECT results of investigation in hormone-sensitive non-metastatic prostate cancer 79Figure 21: Provenge - Datamonitor drug assessment summary, 2009 82Figure 22: Datamonitor drug assessment summary for the standardized cancer vaccines in late-phase clinical development in theseven major markets, 2009 86Figure 23: Abagovomab SWOT analysis, 2009 92Figure 24: Phase I/II study results of abagovomab in ovarian cancer 94Figure 25: Phase I/II study results of abagovomab in ovarian cancer 95Figure 26: Abagovomab - Datamonitor drug assessment summary, 2009 97Figure 27: Allovectin-7 SWOT analysis, 2009 101Figure 28: Phase II results investigating high-dose Allovectin-7 in recurrent or unresponsive Stage III/IV melanoma 103Figure 29: Allovectin-7 - Datamonitor drug assessment summary, 2009 105Figure 30: Gp100:2019-217(210M) SWOT analysis, 2009 108Figure 31: Phase III trial results for gp100:209-217(210M) plus high-dose (HD) interleukin-2 (IL-2) in melanoma 109Figure 32: GV-1001 SWOT analysis, 2009 114Figure 33: Phase I/II trial results investigating GV-1001 in unresectable pancreatic cancer 116Figure 34: GV-1001 - Datamonitor drug assessment summary, 2009 118Figure 35: Lucanix SWOT analysis, 2009 121Figure 36: Phase II results for Lucanix in advanced non-small cell lung cancer (NSCLC) 123Figure 37: Lucanix - Datamonitor drug assessment summary, 2009 125Figure 38: MAGE-A3 ASCI SWOT analysis, 2009 129Figure 39: Phase II results for MAGE-A3 ASCI as adjuvant therapy in completely resected Stage IB/II non-small cell lung cancer(NSCLC) 131Figure 40: Phase II results for MAGE-A3 ASCI unresectable and metastatic melanoma 132Figure 41: MAGE-A3 ASCI - Datamonitor drug assessment summary, 2009 135Figure 42: MDX-1379 SWOT analysis, 2009 140Figure 43: Phase II trial results investigating a second-line combination of ipilimumab and MDX-1379 in Stage IV melanoma patients142Figure 44: MDX-1379 - Datamonitor drug assessment summary, 2009 144Figure 45: PR1 peptide antigen SWOT analysis, 2009 148Figure 46: Phase I/II trial results investigating PR1 peptide antigen in mixed myeloid hematological malignancies 150Figure 47: PR1 peptide antigen - Datamonitor drug assessment summary, 2009 152Figure 48: Stimuvax SWOT analysis, 2009 156Figure 49: Phase IIb results for Stimuvax maintenance therapy in advanced non-small cell lung cancer (NSCLC) 158Figure 50: Stimuvax - Datamonitor drug assessment summary, 2009 161Pipeline Insight: Therapeutic Cancer Vaccines - Prospect of first approval set to reinvigorate interest from major companies Page 10/12
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