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Stakeholder Opinions: Therapeutic Vaccines - A far-off promise of greatness

Datamonitor
December 17, 2009
SKU: DFMN2539759

Abstract Table of Contents Related Reports

Introduction

The development of therapeutic vaccines has expanded beyond cancer indications and is attracting increasing interest from Pharma and Biotech, driven by potential advantages such as improved specificity, long-lasting immune response and cost-savings compared to conventional pharmacotherapy. First candidates have reached late-stage clinical development.

Scope

Strategic analysis of therapeutic vaccine pipelines and key clinical candidates across several disease areas outside cancer
Thorough assessment of opportunities and challenges for therapeutic vaccine development
Review of potential strategies to increase the efficacy of therapeutic vaccines
In-depth discussion of key target diseases, unmet needs and rationales for therapeutic vaccine development

Highlights

Efficacy and safety as well as the lack of suitable animal models remain key issues in therapeutic vaccine design and development. A prudent combination of suitable antigens, adjuvants and delivery systems will be crucial to creating efficacious therapeutic vaccines.

Other strategies to increase the efficacy of therapeutic vaccination may include a combination of therapeutic vaccination and pharmacotherapy as well as targeting of early-stage patients, who are more likely to mount a sufficient immune response.

Candidates for the treatment of substance dependence and diabetes have advanced furthest, whereas experts are more sceptical about the prospects of therapeutic vaccination in cardiovascular and autoimmune diseases. Disease-specific risk/benefit profiles will be key to regulatory approval.

Reasons to Purchase

Review therapeutic vaccine progress in four key disease areas outside cancer
Gain insight into the market environment for therapeutic vaccines through an analysis of pipelines, key candidates and regulatory trends
Understand challenges, unmet needs and future opportunities by learning about the views of industry and academic key opinion leaders

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Overview: Catalyst; Summary; About Datamonitor healthcare; About the healthcare research & analysis team; Executive Summary; Scope of the analysis; Datamonitor insight into the therapeutic vaccines market; Related reports; Upcoming reports; Therapeutic vaccination - an overview; Key findings; General considerations; Therapeutic vaccines induce either T-cell or B-cell mediated immune responses; Dendritic cells (DCs) play a key initial role in human immunity.; T-cell based immune responses lead to an eradication of pathogens or infected cells by cytotoxic T-cells; B-cell based immune responses lead to the production of antibodies; Monoclonal antibody therapy has laid a good foundation for therapeutic vaccine development in some disease areas; Potential advantages and challenges of therapeutic vaccination; Advantages; Therapeutic vaccines could offer targeted therapies with increased specificity; The longevity of an immune response would reduce therapy times; Therapeutic vaccination may be able to provide a cure for some diseases which currently require lifelong treatment; Therapeutic vaccines could significantly reduce treatment costs for some indications; Challenges; Lack of understanding of the disease mechanism handicaps therapeutic vaccine development in some indications; Lack of involvement of Big Pharma is threatening progress in the sector; Safety is a key concern for therapeutic vaccination approaches; Reaching efficacy remains the main challenge for therapeutic vaccines; Strategies used to increase the efficacy of therapeutic vaccines; Adjuvants can increase vaccine immunogenicity, but are often associated with safety concerns; Antigen design and delivery - advantages for organized antigen structures; Mucosal or dermal administration could offer benefits, but is perceived as less important by experts; Combination of therapeutic vaccines with standard therapy could increase efficacy; Regulatory situation; Overview of indications outside cancer targeted by therapeutic vaccines; Therapeutic vaccines in cardiovascular and metabolic diseases; Key findings; Overview; Hypertension vaccines; Rationale for development of vaccines against hypertension; Disease background: over 25% of adults are suffering from hypertension; Compliance is a key challenge for existing hypertension therapy; Pipeline overview; Profiles of key candidates; CYT-006-AngQb (Cytos Biotechnology); Angiotensin Therapeutic Vaccine (BTG); Outlook for hypertension vaccines; Atherosclerosis vaccines; Rationale for development of vaccines against atherosclerosis; Disease background: atherosclerosis is the main underlying condition for coronary heart disease or stroke; Current atherosclerosis treatment is based on statin therapy; Pipeline overview; Outlook for atherosclerosis vaccines; Diabetes vaccines; Rationale for development of vaccines against diabetes; Disease background: the prevalence of diabetes is increasing due to an aging population and sedentary lifestyle; Vaccination could add significant value to diabetes therapy, particularly in type 1 patients; Pipeline overview; Profiles of key candidates; Diamyd (Diamyd Medical AB); Outlook for diabetes vaccines; Therapeutic vaccines in CNS diseases; Key findings; Overview; Substance dependence vaccines; Rationale for development of vaccines against substance dependence; Disease background: nicotine dependence is the most prevalent substance dependence; Current treatments are inadequate for preventing smoking relapse; Vaccination could provide a safe and more efficacious alternative to existing therapies; Pipeline overview; Profiles of key candidates; NicVAX (Nabi Biopharmaceuticals/GlaxoSmithKline); NIC-002 (Novartis/Cytos Biotechnology); TA-NIC (Celtic Pharma); Niccine (Independent Pharmaceutica AB); TA-CD (Celtic Pharma); Outlook for substance dependence vaccines; Alzheimer’s disease vaccines; Rationale for development of vaccines against Alzheimer’s disease; Disease background: Abeta and tau as main targets for future drugs; The number of people suffering from Alzheimer’s disease is increasing across the seven major markets; Current treatments are symptomatic, with no disease-modifying drugs available; Therapeutic vaccination appears a promising concept for the therapy of Alzheimer’s disease; The termination of AN1792 has taught valuable lessons for vaccine design; Pipeline overview; Profiles of key candidates; ACC-001 (Johnson & Johnson/Pfizer); CAD-106 (Novartis/Cytos Biotechnology); Outlook for Alzheimer’s disease vaccines; Therapeutic vaccines in autoimmune disorders; Key findings; Overview; Rationale for development of vaccines against autoimmune diseases; Rheumatoid arthritis is a key target disease for vaccine makers; Disease background: rheumatoid arthritis is a chronic disease, mainly affecting the elderly; Antibody-based treatments have provided proof-of-concept for immunotherapy of rheumatoid arthritis; Vaccines could address several unmet needs in rheumatoid arthritis therapy; Multiple sclerosis is another key target for vaccine developers; Disease background: multiple sclerosis is a chronic disease causing severe damage to the central nervous system; Current treatment: interferons remain the backbone of multiple sclerosis therapy; Key unmet needs in multiple sclerosis therapy include improved efficacy and safety; Vaccination is a promising approach for the treatment of autoimmune diseases; Pipeline overview; Profiles of key candidates; Tovaxin (Opexa); BHT-3009 (Bayhill Therapeutics); Outlook for therapeutic vaccines against autoimmune diseases; Therapeutic vaccines in infectious diseases; Key findings; Overview; Hepatitis B therapeutic vaccines; Rationale for development of therapeutic vaccines against hepatitis B; Disease background: over 360 million people globally suffer from chronic hepatitis B; Current therapy is based on interferons and antivirals; Vaccination could improve efficacy, convenience and susceptibility to resistances; Pipeline overview; Profiles of key candidates; Hepatitis B virus vaccine (Emergent Biosolutions); Outlook for therapeutic hepatitis B vaccines; Hepatitis C therapeutic vaccines; Rationale for development of therapeutic vaccines against hepatitis B; Disease background - hepatitis C is a key underlying condition for cirrhosis and liver cancer; Current treatment gold standard is combination therapy with peginterferon / ribavirin; Unmet needs include efficacy in genotype 1 patients, tolerability and shorter treatment duration; Hepatitis C is a challenging target for vaccine developers; Pipeline overview; Profiles of key candidates; GI-5005 / HepCVax (GlobeImmune); IC41 (Intercell); ChronVac-C (Tripep/Inovio); Outlook for therapeutic hepatitis C vaccines; Human immunodeficiency virus (HIV); Rationale for the development of therapeutic vaccines against HIV; Disease background - HIV prevalence is highest in the developing world; HAART has transformed HIV into a chronic disease, with many treatment options available; Viral eradication remains the most important unmet need in HIV therapy; Although promising in theory, vaccination against HIV faces significant challenges in practice; Pipeline overview; Clinical failure of Merck & Co’s prophylactic candidate has increased concerns regarding the feasibility of therapeutic HIV vaccination; Profiles of key candidates; Vacc-4x (Bionor Immuno); AGS-004 (Argos Therapeutics/Kyowa Hakko Kirin); Outlook for therapeutic HIV vaccines
Bibliography: Journals; Websites; Datamonitor reports
Appendix A: Data definitions, limitations and assumptions; Standard units; Country group definitions; Rest of European Union; Middle East and North Africa (MENA); Rest of World
Appendix B: Contributing experts; Conferences attended; Report methodology; About Datamonitor; About Datamonitor Healthcare; About the Infectious Diseases analysis team; Key therapy team members; Holger Rovini, Head of Respiratory and Infectious Diseases; Hedwig Kresse, Senior Analyst, Infectious Diseases; Disclaimer

Stakeholder Opinions: Therapeutic Vaccines - A far-off promise of greatness

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