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

Datamonitor, December 2009, Pages: 160

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 of this title

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.

Key reasons to purchase this title

- 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

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

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