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Pipeline Insight: Cancer Vaccines and Cell Therapies
Technical Know How Needs Translation Into Clinical and Commercial Rewards
Publication Date April 2005
Publisher Datamonitor
Product Type Report
Pages 203
ISBN Number not applicable
Product Code DAT299
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Summary
Unmet need across the cancer market is high, with most therapies conferring low levels of specificity and high toxicity. Development of cancer vaccines may be the holy grail, with the promise of high specificity, low toxicity and prolonged activity. Despite years of R&D and enhanced understanding of tumor immunology, a reproducible survival benefit has proved elusive, leaving the market wide open.
- Examination of cancer vaccine pipeline with in-depth clinical and commercial profiles of Phase III candidates, incorporating Datamonitor opinion
- Seven market sales forecasts, commercial potential and research/clinical/commercial assessment of Phase III agents to 2014
- Analysis of the cancer vaccine market, identifying developmental, manufacturing, logistical, regulatory and commercialization issues
- Insight and commentary from qualitative interviews with oncology opinion leaders in the US and Europe Given the relative immaturity and lack of precedence of the cancer vaccine market, an entirely new set of clinical and strategic issues has been brought to light. Significant hurdles need to be overcome, both on a local and international level before successful commercialization of a cancer vaccine can be realized.Cancer vaccines will complement current treatment approaches, rather than serve as a replacement. If the full potential of cancer vaccines is realized, the need for multiple-lines of treatment may be eliminated, ultimately driving the cost of oncology care down.The majority of the cancer vaccine pipeline constitutes off-the-shelf vaccines rather than personalized or cell-based formulations. Although the former are capable of mass manufacture, the latter have shown greater clinical benefit, but encompass a more complex and expensive formulation. It is unclear which class will reach the market first.
- Identify the key cancer vaccines and cell therapies in the current pipeline based on sales forecasts to 2014 and Datamonitor drug assessments
- Assess opportunities and risks for cancer vaccines and cell therapies within the oncology market
- Optimize development and commercialization of cancer vaccines by improving strategic planning
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Content
- Chapter 1 Executive Summary
- Datamonitor insight into the cancer vaccines market
- Chapter 2 Pipeline Overview & Future Focus
- Pipeline overview
- Antigen-specific vaccines are the major focus of development
- Antigen-specific vaccines constitute over half of the current cancer vaccine pipeline
- Potential commercial rewards dictate tumor focus
- 'Big four' tumor types remain popular indications, joined by immunologically driven malignancies, such as melanoma and renal cell carcinoma
- As anticipated, the majority of the pipeline is made up of generalized rather than personalized cancer vaccines
- Fragmentation of the cancer vaccine market means strategic partnerships with major oncology players will ease the path to commercialization
- Key metrics
- Datamonitor pipeline assessment summary
- Future focus - cancer vaccines face many challenges on route to approval
- Chapter 3 Pipeline Dynamics
- A diverse range of disease subtypes
- Genetic basis of cancer evolution
- Tumorigenesis is the result of cooperative 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
- Increased therapeutic and generic competition results in reduced periods of market exclusivity
- Segmentation of market will require changes in clinical trial methodology
- Chapter 4 Cancer Vaccines & Cell Therapies Overview
- The goal: active, specific immunotherapy
- Skepticism surrounds the history and future commercial viability of this technology
- Overcoming immune tolerance is the key to success
- Classification of pipeline products
- Polyvalent vaccines
- Antigen-specific vaccines
- Dendritic cell vaccines
- Prophylactic vaccines
- Relative merits of different cancer vaccine approaches show no clear market leader
- Chapter 5 New Market, New Issues
- Lack of precedent confers unique strategic challenges
- Regulatory issues cloud the road to commercialization
- Formulation and manufacturing concerns raised by regulatory bodies
- Skepticism over cost-effectiveness hampers commercialization
- Prophylactic vaccines have demonstrable clinical benefit
- Wide range of indications under development makes it difficult to compare efficacies of each class of cancer vaccine
- Changing the paradigm in clinical trial design
- Clinical trial endpoints are starting to evolve to accommodate changing needs
- Investigators must establish and consistently employ standard response criteria specific to the assessment of cancer vaccines
- Immune monitoring should be integral to assessing the efficacy of vaccine strategies
- Optimizing cancer vaccine delivery strategies
- Cancer vaccines are likely to be most efficacious in the setting of minimal residual disease
- Timing of vaccine delivery is crucial if part of multi-modality regimen
- Strategies to overcome the influence of neutralizing antibodies following vaccine administration
- Significant hurdles challenge the path to commercialization
- Chapter 6 Polyvalent Vaccines Drug Analysis & Forecasts
- In comparison to autologous vaccines, allogeneic approaches are likely to realize an expedited path to commercialization
- Pipeline overview
- Cell Genesys's GVAX counters the belief that there is no dose-related effect with cancer vaccines
- CancerVax/Serono's Canvaxin - despite FDA action hampering developmental partnership increases first-to-market potential
- Antigenics's Oncophage - early-stage trials have demonstrated limited clinical benefit
- Forecasts
- Datamonitor drug assessment summary
- Chapter 7 Antigen-Specific Vaccines Drug Analysis & Forecasts
- High rate of clinical failure associated with antigen-specific vaccines in late-stage development
- Pipeline overview
- Aphton/Sanofi-Aventis's Insegia (G17DT) fails to meet primary endpoint in Phase III pancreatic cancer study
- Biomira's Theratope - failed Phase III study casts doubt over commercial viability
- Progenics' GMK - despite relevance of antigen, Phase III trials have failed to demonstrate clinical benefit
- Medarex/Bristol-Myers Squibb's MDX-1379 - evidence of enhanced immune response is accompanied by potentially dose-limiting autoimmunity
- Therion Biologics' PANVAC-VF - validity of antigen targets could offer hope to pancreatic cancer patients
- Igeneon's IGN-101 - low awareness of both the company and its lead product candidate present a major hurdle
- Favrille's FavID - by targeting patient population with few recognized treatment options, regulatory bar is lowered
- Biovest/Accentia's BIOVAXID - companies should strive to exploit potential first-to-market advantage
- Genitope's MyVax - second-to-market status may be saved by targeting slightly different patient population than BIOVAXID
- Vical's Allovectin-7 - another vaccine that confounds the theory of an absence of dose-related effect
- Forecasts
- Datamonitor drug assessment summary
- Chapter 8 Dendritic Cell Vaccines Analysis & Forecasts
- Dendreon's Provenge forges the way in the technologically appealing dendritic cell approach
- Pipeline overview
- Dendreon's Provenge (APC-8015) - promises to be first to market within this class of vaccines
- Forecasts
- Datamonitor drug assessment summary
- Appendix A
- List of tables
- List of figures
- Methodology
- Datamonitor forecast methodology
- Datamonitor drug assessment summary
- Contributing experts
- Opinion leader interview transcripts
- Doctor Vincenzo Cerundolo, Professor of Immunology, Head Cancer Research UK Tumor Immunology Program, Associate Director of MRC Human Immunology Unit, Weatherall Institute of Molecular Medicine, University of Oxford, Oxford, UK
- Doctor John Grange, Professor, Centre for Infectious Diseases and International Health, Department of Medicine, Royal Free and University College Medical School, London, UK
- Doctor Elke Jaeger, Medical Oncologist, Department of Oncology, Krankenhaus Nordwest, Frankfurt, Germany
- Doctor Howard Kaufman, Vice Chairman of Surgical Oncology & Associate Professor of Clinical Surgery, Department of Surgery, Columbia University, New York, US
- Doctor Philip Livingston, Medical Oncologist, Memorial Sloan-Kettering Cancer Center, New York, US
- Doctor Daniel Speiser, Associate Member, Division of Clinical Onco-immunology, Ludwig Institute for Cancer Research, Lausanne, Switzerland
- Bibliography
- Appendix B
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