Therapeutic Vaccines for Cancer: On the Threshold of Success

TABLE OF CONTENTS

Chapter 1: Executive Summary

• References

Chapter 2: Introduction

• Historical Perspective
• Basic Immunological Principles Discussed in This Report
• Intermediate Immunological Principles Discussed in This Report
• References

Chapter 3: Assessment of the Current State of Therapeutic Development

• Reasons for Pessimism
• Reasons for Optimism
• References

Chapter 4: Development Strategies

• Antigen Selection
  • In Search of the Ideal Antigen
• Common Antigens in Cancer Vaccines
  • Complex Antigen Cocktails: Autologous versus Allogeneic
• Current Development Strategies
• Adjuvants
  • Late-stageLate- Stage Clinical Development
  • Phase I and Preclinical
  • Halted
• Peptides
  • Late-Stage Clinical Development
  • Phase I and Preclinical
  • Halted
• Plasmid DNA and Viral Vectors
  • Late-Stage Clinical Development
  • Phase I and Preclinical
  • Halted
• Microbial Vectors
  • Phase I and Preclinical
• Tumor Cells
  • Late-Stage Clinical Development
  • Phase I and Preclinical
  • Halted
• Dendritic Cells (DCs)
  • Late-Stage Clinical Development
  • Phase I and Preclinical
  • Halted
• Other Strategies
  • Late-Stage Clinical Development
  • Phase I and Preclinical
  • Halted
• Future Strategies
  • Maintenance
  • Removing Inhibition in the Local Tumor Environment
  • Activating The Innate System
• Clinical Trials
• Surrogate Markers
• Standardizing and Combining Trials
  • Trials in the Sickest of the Sick
• Market Model
  • Methodology and Assumptions
  • Forecast
• References
• Endnotes

Chapter 5: Company Pro.les

• Anosys, Inc.
• Antigenics Inc.\
• Argos Therapeutics, Inc.
• AVAX Technologies, Inc.
• Biomira Inc. . 5�E6
• CancerVax Corporation
• Cerus Corporation
• Corixa Corporation
• Cytogen Corporation
• Dendreon Corporation
• Enzo Biochem, Inc.
• Favrille, Inc.
• Genitope Corporation
• Genzyme Corporation
• IDM S.A.
• Immune Response Corporation
• Juvaris BioTherapeutics, Inc.
• Medarex, Inc.
• NEMOD Biotherapeutics GmbH & Co. KG
• Northwest Biotherapeutics, Inc.
• NovaRx Corporation
• Oxxon Therapeutics Inc.
• Therion Biologics Corporation
• Transgene S.A.
• Vical Inc.

TABLE OF EXHIBITS

• Exhibit 3.1 Cancer Vaccines in Phase III Clinical Trials
• Exhibit 3.2 Cancer Vaccines in Phase II Clinical Trials
• Exhibit 3.3 Survey Question: How would you rank the following criteria in importance?
• Exhibit 3.4 Results of Clinical Vaccine Studies in Patients with Metastatic Cancers
• Exhibit 4.1 Survey Question: How do you rank the following challenges in developing therapeutic cancer vaccines?
• Exhibit 4.2 Examples of Tumor Antigens
• Exhibit 4.3 Survey Question: Please rank the following development strategies as to which you think is the most likely to succeed (adapted from Berzofsky, et al.)
• Exhibit 4.4 Survey Question: What are the most promising methods for improving cancer immunotherapeutics?
• Exhibit 4.5 Technologies for Monitoring Immune Responses
• Exhibit 4.6 Survey Question: Which of the following therapeutic vaccines currently in Phase III do you think is most likely to succeed?
• Exhibit 4.7 Projected U.S. Market for Therapeutic Vaccines