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Pipeline Insight: Therapeutic Cancer Vaccines - A turbulent path from bench to bedsidePublished by: Datamonitor Published: Dec. 20, 2006 - 234 Pages Table of ContentsABOUT DATAMONITOR HEALTHCARE About the Oncology pharmaceutical analysis team CHAPTER 1 EXECUTIVE SUMMARY Scope of analysis Datamonitor insight into the cancer vaccines market Key metrics Datamonitor pipeline assessment summary CHAPTER 2 PIPELINE DYNAMICS Pipeline overview Therapeutic cancer vaccines in late-phase development Therapeutic cancer vaccines in Phase II development Therapeutic cancer vaccines in Phase I development Pipeline by developmental phase and class There are over 100 different therapeutic cancer vaccines in the clinical developmental pipeline Pipeline by technology platform Lack of precedent is reflected by diversity of technology platforms Pipeline by vaccine specificity As expeceted, generalized vaccines dominate over personalized therapies Pipeline by indication Cancer vaccines are being investigated in 18 different tumor types Pipeline by company Developmental pipeline dominated by small pharma/biotech players Only 14 companies/institutes have more than one candidate in the cancer vaccine developmental pipeline CHAPTER 3 DISEASE OVERVIEW A diverse range of disease subtypes Genetic basis of cancer evolution Tumorigenesis is the result of co-operative accumulated mutations Existing pharmacotherapy approaches provide limited treatment benefit Cytotoxic drugs lack specificity Hormonal or endocrine therapy provides incremental benefit in selected tumors Optimizing current treatment strategies is paramount The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy Dynamic cancer market offers significant commercial opportunity Ongoing sales growth drives the market Intensive R&D produces a rich developmental pipeline Growing patient population and significant unmet needs propel innovation in the cancer market Clinical and strategic threats to the commercialization of cancer drugs Progressively rising R&D costs threaten industry productivity Pharmacoeconomic pressures drive payers to implement restrictive pricing and reimbursement policies Therapeutic and generic competition reduces periods of market exclusivity Segmentation of market will require changes in clinical trial methodology CHAPTER 4 MARKET DEFINITION AND PIPELINE CLASSIFICATION Active, specific immunotherapy Overcoming immune tolerance is key to success Types of targets for vaccine therapy Classification of pipeline products Antigen-specific vaccines Polyvalent vaccines Dendritic cell vaccines Prophylactic vaccines Relative merits of therapeutic cancer vaccines CHAPTER 5 NEW MARKET, NEW ISSUES Integrating therapeutic cancer vaccines into current treatment paradigms Cancer vaccines are likely to broaden existing treatment options not replace them Immunosuppressive therapy can compromise the efficacy of a cancer vaccine Cancer vaccines are likely to be most effective in the setting of minimal residual disease Multiple vaccinations can induce development of strong neutralizing antibodies Adjuvants can improve the immunogenicity of a cancer vaccine Clinical trial design and surrogate endpoints for cancer vaccines Clinical trial endpoints must adapt in line with changing needs Should immune monitoring be integral to assessing the efficacy of vaccine strategies? Strategic challenges facing the commercialization of cancer vaccines Regulatory issues cloud the road to commercialization Formulation and manufacturing of cancer vaccines can become a major cause for concern Skepticism over cost-effectiveness hampers commercialization Wide range of indications under development makes it difficult to compare efficacies of each class of cancer vaccine Significant hurdles challenge the path to commercialization CHAPTER 6 ANTIGEN-SPECIFIC CANCER VACCINES ANALYSIS & FORECASTS Pipeline overview Late-phase pipeline of antigen-specific cancer vaccines Phase II pipeline of antigen-specific cancer vaccines Phase I pipeline of antigen-specific cancer vaccines MGI Pharma Biologics’ Amolimogene (Biotope-CD; ZYC101a) Drug profile Clinical trial data Datamonitor comments Pharmexa’s GV1001 Drug profile Clinical trial data Datamonitor comments Bristol-Myers Squibb’s MDX-1379 Drug profile Clinical trial data Datamonitor comments Oxford BioMedica’s TroVax (MVA-h5T4) Drug profile Clinical trial data Datamonitor comments Progenics’ GMK (GM2-KLH) Drug profile Clinical trial data Datamonitor comments Receptor BioLogix’s Insegia (G17DT) Drug profile Clinical trial data Datamonitor comments Accentia Biopharmaceuticals’ BIOVAXID Drug profile Clinical trial data Datamonitor comments Favrille’s FavId (Id-KLH) Drug profile Clinical trial data Datamonitor comments Genitope’s MyVax (GTOP-99) Drug profile Clinical trial data Datamonitor comments Comparison of anti-idiotype vaccines Forecasts Datamonitor drug assessment summary CHAPTER 7 POLYVALENT CANCER VACCINES ANALYSIS & FORECASTS Pipeline overview Late-phase pipeline of polyvalent cancer vaccines Phase II pipeline of polyvalent cancer vaccines Phase I pipeline of polyvalent cancer vaccines AVAX Technologies’ M-Vax Drug profile Clinical trial data Datamonitor comments Cell Genesys’ GVAX Drug profile Clinical trial data Datamonitor comments Intracel’s OncoVAX Drug profile Clinical trial data Datamonitor comments Antigenics’ Oncophage (Vitespen; HSPPC-96) Drug profile Clinical trial data Datamonitor comments Forecasts Datamonitor drug assessment summary CHAPTER 8 DENDRITIC CELL CANCER VACCINES ANALYSIS & FORECASTS Pipeline overview Dendreon’s Provenge (Sipuleucel-T; APC-8015) Drug profile Clinical trial data Datamonitor comments Forecasts Datamonitor drug assessment summary APPENDIX A List of tables List of figures Methodology Datamonitor forecast methodology Datamonitor drug assessment summary Abbreviations Contributing experts Key opinion leader interview transcripts Bibliography APPENDIX B About Datamonitor About Datamonitor Healthcare About the Oncology analysis team Disclaimer AbstractIntroductionUnmet needs across the cancer market remain high, with most therapies conferring low levels of specificity and high toxicity. Therapeutic cancer vaccines offer an attractive therapeutic addition, delivering treatment of high specificity, low toxicity and prolonged activity. However, despite years of R&D, a reproducible survival benefit has proved elusive, leaving the market wide open. Scope
105 different pipeline cancer vaccines have been identified of which 14 are in late-phase development. These existing candidates have a forecast sales potential of up to $3.1 billion in the seven major pharmaceutical markets by 2015. Despite Dendreon's Provenge preregistration status, skepticism still surrounds the use of dendritic cells as a viable technology platform. Indeed, an entirely new set of clinical and strategic issues has been brought to light across the spectrum of cancer vaccine development classes. While personalized immunotherapies offer greater levels of specificity and lower toxicity, generalized alternatives should facilitate production, help achieve economies of scale and offer broader utility in a range of tumor types. It is therefore not suspiring that these 'off-the-shelf' products dominate the current pipeline. Reasons to Purchase
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