Immunotherapies and Vaccines for Cancer and Infectious Diseases Report Overview

Author: Lucy J. Sannes, PhD, MBA

Chapter 1
INTRODUCTION
1.1. The Immune System
1.2. Scope of This Report

Chapter 2
MAJOR CANCERS AND INFECTIOUS DISEASES TARGETED BY NEW AND/OR EMERGING IMMUNOTHERAPIES AND VACCINES TO ENHANCE THE IMMUNE SYSTEM
2.1. Major Cancers Targeted by Immunotherapies and Vaccines
Brain Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Leukemia
Lung Cancer
Non–Small-Cell Lung Cancer
Small-Cell Lung Cancer
Lymphoma (Non–Hodgkin’s Lymphoma)
Melanoma
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Renal Cancer
2.2. Major Infectious Diseases Targeted by Emerging Immunotherapies and Vaccines
Anthrax
Campylobacter
Cytomegalovirus
Dengue
Diphtheria
Encephalitis
Haemophilus influenzae Type b
Hepatitis B Virus
Hepatitis C Virus
Herpes Simplex Virus
Human Immunodeficiency Virus
Human Papillomavirus
Influenza
Malaria
Meningococcal Disease; Neisseria meningitidis
Pertussis
Pneumococcal Disease; Streptococcus pneumoniae
Polio (Poliomyelitis)
Respiratory Syncytial Virus
Tetanus
Tuberculosis
West Nile Virus

Chapter 3
CURRENT PHARMACOLOGICAL OPTIONS FOR TREATMENT AND PREVENTION OF CANCER, AND IMMUNOTHERAPY/VACCINE OPTIONS FOR TREATMENT AND PREVENTION OF INFECTIOUS DISEASES
3.1. Current Pharmacological Options for Treatment and Prevention of Cancer
Brain Cancer
Breast Cancer
Chemotherapy
Hormone Therapy
Targeted Therapy: HER2-Positive Cancers
Targeted Therapy: VEGF and Angiogenesis
Cervical Cancer
Colorectal Cancer
Chemotherapy
Targeted Therapy: Monoclonal Antibodies
Leukemia
Pharmacological Therapies (Chemotherapy and Others)
Bone Marrow Transplants and Peripheral Stem Cell Transplants
Lung Cancer
Chemotherapy (Non–Small-Cell Lung Cancer)
Targeted Therapy: Kinase Inhibitors (Non–Small-Cell Lung Cancer)
Targeted Therapy: Monoclonal Antibodies (Non–Small-Cell Lung Cancer)
Photodynamic Therapy (Non–Small-Cell Lung Cancer)
Chemotherapy (Small-Cell Lung Cancer)
Lymphoma (Non–Hodgkin’s Lymphoma)
Chemotherapy
Monoclonal Antibodies
Other Immune-Based Therapies
Other Targeted Therapies: Histone Deacetylase Inhibitor
Melanoma
Interferon
Interleukin-2
Chemotherapy
Ovarian Cancer
Pancreatic Cancer
Chemotherapy
Targeted Therapy: Inhibition of EGFR Tyrosine Kinase
Prostate Cancer
Luteinizing Hormone–Releasing Hormone Agonists
Antiandrogens
Chemotherapy
Renal Cancer
Interferon
Interleukin-2
Targeted Therapy: Kinase Inhibitors
3.2. Current Infectious Disease Immunotherapies and Vaccines
Passive Immunotherapy
Immunotherapy for Treatment of Chronic Infections
Infectious Disease Vaccines
3.3. Medical and Market Needs; R&D Challenges
Cancer Immunotherapies and Vaccines
Infectious Disease Immunotherapies and Vaccines

Chapter 4
EXAMPLES OF CURRENT AND EMERGING APPROACHES TO ENHANCE THE IMMUNE SYSTEM FOR PREVENTION AND TREATMENT OF DISEASE
4.1. New Approaches for Cancer Immunotherapy and Vaccines
Nonspecific Active Immunotherapy (Immune-Modulating Agents)
Antigen Immunotherapies/Vaccines (Allogeneic)
Autologous Antigen Immunotherapies/Vaccines
Allogeneic Whole-Tumor-Cell Immunotherapies/Vaccines
Autologous Whole-Tumor-Cell Immunotherapies/Vaccines
Dendritic Cell Immunotherapies/Vaccines
DNA and Viral Vector Vaccines
4.2. Infectious Disease Vaccines
Types of Vaccines
Adjuvants

Chapter 5
CANCER IMMUNOTHERAPIES AND VACCINES IN DEVELOPMENT
5.1. Brain Cancer
Advantagene
Antisense Pharma
Celldex Therapeutics
Merck Serono
Northwest Biotherapeutics
5.2. Breast Cancer
Antigen Express (Subsidiary of Generex Biotechnology)
Apthera
Celldex Therapeutics
Introgen Therapeutics
Peregrine Pharmaceuticals
5.3. Cervical Cancer
5.4. Colorectal Cancer
Celldex Therapeutics
GenVec
immatics biotechnologies
Oxford BioMedica and sanofi-aventis
Vaccinogen
5.5. Leukemia
Argos Therapeutics
Cell Genesys
Geron
The Vaccine Company
5.6. Lung Cancer
Agennix
AVAX Technologies
GlaxoSmithKline
GlobeImmune
IDM Pharma
Introgen Therapeutics
Merck Serono and Oncothyreon
Merck Serono
NovaRx
Peregrine Pharmaceuticals
Pfizer
Pharmexa
Transgene
Vaxon Biotech
5.7. Lymphoma (Non–Hodgkin’s Lymphoma)
Biovest International
Transgene
5.8. Melanoma
Antigenics
AVAX Technologies
BioVex
GenVec
GlaxoSmithKline
Medarex and Bristol-Myers Squibb
Merck Serono
Oxford BioMedica
Sanofi Pasteur
SciClone Pharmaceuticals and Sigma-Tau
Vical
ZymoGenetics
5.9. Ovarian Cancer
AVAX Technologies
Menarini Group
5.10. Pancreatic Cancer
Celldex Therapeutics
Cell Genesys
GenVec
GlobeImmune
Lorus Therapeutics and Zor Pharmaceuticals
Pharmexa
5.11. Prostate Cancer
Advantagene
Bavarian Nordic
Cell Genesys
Dendreon
Northwest Biotherapeutics
Onyvax
Oxford BioMedica and sanofi-aventis
5.12. Renal Cancer
Active Biotech
Agennix
Antigenics
Argos Therapeutics
Endocyte
Idera Pharmaceuticals and Merck Serono
immatics biotechnologies
LipoNova
Oxford BioMedica and sanofi-aventis
ZymoGenetics
5.13. Immunotherapies and Vaccines in Development for Other or Nonspecified Cancer Indications

Chapter 6
IMMUNOTHERAPIES AND VACCINES IN DEVELOPMENT FOR PREVENTION AND TREATMENT OF INFECTIOUS DISEASES
6.1. Anthrax and Other Biodefense Vaccines
6.2. Campylobacter and/or Enterotoxigenic Escherichia coli (Traveler’s Diarrhea)
Ace Biosciences
Intercell
6.3. Cytomegalovirus
Vical
6.4. Dengue
GlaxoSmith Kline
Sanofi Pasteur
6.5. Encephalitis
Novartis and Intercell
Sanofi Pasteur
6.6. Hepatitis B
Emergent BioSolutions
Merck and Dynavax
6.7. Hepatitis C
GlobeImmune
Hemispherx Biopharma
Human Genome Sciences and Novartis
Novartis Vaccines and Intercell
SciClone Pharmaceuticals
6.8. Herpes Simplex Virus
GlaxoSmithKline
6.9. Human Immunodeficiency Virus (HIV)
Argos Therapeutics
Bionor Immuno
GenVec
Hemispherx Biopharma
Sanofi Pasteur
Targeted Genetics
6.10. Human Papillomavirus (HPV)
GlaxoSmithKline
Merck
MGI Pharma (Subsidiary of Eisai)
Transgene and Roche
6.11. Influenza
Baxter Vaccines
CSL Biotherapies
GlaxoSmithKline
Novartis Vaccines
Protein Sciences Corporation
Sanofi Pasteur
6.12. Malaria
GlaxoSmithKline
6.13. Meningococcal Disease; Neisseria meningitidis
GlaxoSmithKline
Novartis
6.14. Pneumococcal Disease; Streptococcus pneumoniae
GlaxoSmithKline
Wyeth
6.15. Respiratory Syncytial Virus
6.16. Tuberculosis
Emergent BioSolutions
GlaxoSmithKline
6.17. West Nile Virus
Sanofi Pasteur
6.18. Emerging Combination Vaccines
6.19. Other Emerging Infectious Disease Vaccines

Chapter 7
SELECTED BUSINESS CONSIDERATIONS: IMMUNOTHERAPIES AND VACCINES THAT ENHANCE THE IMMUNE SYSTEM
7.1. Companies in the Infectious Disease and Cancer Vaccines and Immunotherapies Fields
7.2. Diseases Targeted for Product Development
Infectious Disease
Cancer
7.3. Technical Issues and Challenges for Cancer and Infectious Disease Vaccines and Immunotherapies
7.4. Partners (Corporate and Noncorporate) and Acquisitions
7.5. Human Papillomavirus—Infectious Disease Prophylactic Vaccine for Prevention of Cancer: Example of a Controversy with a New Vaccine
Social Issues
Safety Issues

Chapter 8
EXPERT INTERVIEWS
Estuardo Aguilar-Cordova, MD, Founder & Chief Executive Officer, Advantagene, Inc., Waban, MA
David Apelian, MD, PhD, MBA, Vice President, Clinical Development and Regulatory Affairs, and Chief Medical Officer, GlobeImmune, Louisville, CO
Robert Coffin, PhD, Chief Technology Officer, Founder and Director, BioVex, Woburn, MA
Raafat E.F. Fahim, PhD, President and Chief Executive Officer, Nabi Pharmaceuticals, Rockville, MD
Drew Hannaman, Vice President, Research and Development, Ichor Medical Systems, San Diego, CA
Kristen M. Hege, MD, Vice President, Clinical Research and Development, Cell Genesys, South San Francisco, CA
Frank Malinoski, MD, PhD, Senior Vice President, Medical and Scientific Affairs, MedImmune, Gaithersburg, MD
Cynthia W. Tuthill, PhD, Senior Vice President, Scientific Affairs, & Chief Scientific Officer, SciClone Pharmaceuticals, Foster City, CA
Sunny Uberoi, Vice President, Corporate Communications, Antigenics, New York, NY

References

Company Index with Web Addresses

Tables

Table 2.1. Incidence and Prevalence of Selected Cancers in the United States, 2008
Table 2.2. Five-Year Relative Survival Rates by Stage of Diagnosis (1996–2003) for Major Cancers Targeted by Immunotherapies and Cancer Vaccines
Table 3.1. Selected Chemotherapy Drugs that Are FDA Approved for Treatment of Cancer
Table 3.2. Selected Chemotherapy Drugs Approved by the FDA for Treatment of Brain Cancer
Table 3.3. Selected Drugs Approved by the FDA for Treatment of Breast Cancer
Table 3.4. Selected Drugs Approved by the FDA for Treatment of Cervical Cancer
Table 3.5. Selected Drugs Approved by the FDA for Treatment of Colorectal Cancer
Table 3.6. Selected Drugs Approved by the FDA for Treatment of Leukemia
Table 3.7. Selected Drugs Approved by the FDA for Treatment of Lung Cancer (Including NSCLC and SCLC)
Table 3.8. Selected Drugs Approved by the FDA for Treatment of Non–Hodgkin’s Lymphoma
Table 3.9. Selected Drugs Approved by the FDA for Treatment of Melanoma
Table 3.10. Selected Drugs Approved by the FDA for Treatment of Ovarian Cancer
Table 3.11. Selected Drugs Approved by the FDA for Treatment of Advanced or Metastatic Pancreatic Cancer
Table 3.12. Selected Drugs Approved by the FDA for Treatment of Prostate Cancer
Table 3.13. Selected Drugs Approved by the FDA for Treatment of Advanced or Metastatic Renal Cell Carcinoma
Table 3.14. Selected Passive Immunotherapies for Prevention of Infectious Disease Infection and Other Indications
Table 3.15. Selected Active Immunotherapies Approved by the FDA for Treatment of Infectious Diseases
Table 3.16. FDA-Licensed Infectious Disease Vaccines
Table 5.1. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Brain Cancer
Table 5.2. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Breast Cancer
Table 5.3. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Colorectal Cancer
Table 5.4. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Leukemia
Table 5.5. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Lung Cancer
Table 5.6. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Lymphoma (Non–Hodgkin’s Lymphoma)
Table 5.7. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Melanoma
Table 5.8. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Ovarian Cancer
Table 5.9. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Pancreatic Cancer
Table 5.10. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Prostate Cancer
Table 5.11. Selected Cancer Immunotherapies and Vaccines in Clinical Trials for Treatment of Renal Cancer
Table 5.12. Selected Immunotherapies and Vaccines in Development for Other or Nonspecified Cancer Indications
Table 6.1. Selected Anthrax and Other Biodefense Vaccines in Development
Table 6.2. Selected Vaccines in Development to Protect Against Campylobacter and/or Enterotoxigenic Escherichia coli Infections (Traveler’s Diarrhea)
Table 6.3. Selected Vaccines in Development for Cytomegalovirus
Table 6.4. Selected Vaccines in Development for Dengue
Table 6.5. Selected Vaccines in Development for Encephalitis
Table 6.6. Selected Vaccines and/or Immunotherapies in Development for Prevention or Treatment of Hepatitis B Virus Infection
Table 6.7. Selected Vaccines and/or Immunotherapies in Development for Prevention or Treatment of Hepatitis C Virus Infection
Table 6.8. Selected Vaccines in Development for Herpes Simplex Virus Infection (Genital Herpes)
Table 6.9. Selected Vaccines and/or Immunotherapies in Development for Human Immunodeficiency Virus (HIV) Infection
Table 6.10. Selected Vaccines and/or Immunotherapies in Development for Human Papillomavirus (HPV) for Prevention or Treatment of Cervical Dysplasia or Cancer
Table 6.11. Selected Vaccines and/or Immunotherapies in Development for Influenza
Table 6.12. Selected Vaccines and/or Immunotherapies in Development for Malaria
Table 6.13. Selected Vaccines and/or Immunotherapies in Development for Meningococcal Disease (Neisseria meningitidis)
Table 6.14. Selected Vaccines and/or Immunotherapies in Development for Pneumococcal Disease (Streptococcus pneumoniae)
Table 6.15. Selected Vaccines in Development for Respiratory Syncytial Virus (RSV)
Table 6.16. Selected Vaccines in Development for Tuberculosis (TB)
Table 6.17. Selected Vaccines and/or Immunotherapies in Development for West Nile Virus (WNV)
Table 6.18. Selected Combination Vaccines in Development
Table 6.19. Selected Vaccines and/or Immunotherapies in Development for Other Infectious Diseases