Pipeline Insight Therapeutic Cancer Vaccines

A turbulent path from bench to bedside

Publication Date	January 2007
Publisher	Datamonitor
Product Type	Report
Pages	234
ISBN Number	not applicable
Product Code	DAT03301

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Summary

Introduction

Unmet 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

Research and analysis of the cancer vaccines pipeline with in-depth clinical and commercial assessment of Phase III candidates, plus expert opinion
Seven major pharmaceutical market sales forecasts to 2015 for key pipeline candidates incorporating product specific assumptions and events
Segmentation and examination of product pipeline by phase, technology platform, vaccine specificity, indication and developer
Insight and analysis of clinical, regulatory, pharmacoeconomic and strategic issues that challenge the path to commercialization of a cancer vaccine

Highlights

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

Acquire a detailed appreciation and impartial perspective of the entire cancer vaccine developmental pipeline
Identify the key therapeutic cancer vaccines in late-phase development based on sales forecasts to 2015 and Datamonitor's drug assessment methodology
Consider, assess and react to opportunities and risks for cancer vaccines within the oncology market

Content

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 &Amp; 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 &Amp; 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 &Amp; 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