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New Report Sees Combinations of Immunostimulatory Adjuvants With Efficacious Delivery Systems As a Promising Approach

October 16, 2008

Research and Markets (http://www.researchandmarkets.com/research/e1ceb5/stakeholder_opinio) has announced the addition of the “Stakeholder Opinions: Vaccine Adjuvants – Uncertainties Rule” report to their offering.

Adjuvants are coming increasingly into focus for vaccine developers since many novel split- and subunit vaccines are insufficiently immunogenic on their own. Adjuvants offer a solution: they can accelerate, enhance and prolong the immune response to vaccination but also enable the use of antigen-sparing formulations. This makes them an attractive option for prophylactic and therapeutic vaccines.

Scope

– In-depth analysis of key TLR-dependent and TLR-independent adjuvant candidates in clinical development

– Thorough assessment of key opportunities and risks for novel adjuvants

– Review of clinical trials and available data for adjuvants in development

– In-depth discussion of regulatory hurdles and strategic advice on how to overcome them

Highlights of this title

In order to overcome the high regulatory barriers, adjuvant developers should focus on indications with high unmet need and no available vaccines. As safety and reactogenicity will be key factors in the FDAs evaluation of novel adjuvants, the barrier to approval of novel adjuvants is lower for therapeutic than for prophylactic indications.

The report sees combinations of immunostimulatory adjuvants with efficacious delivery systems as a promising approach, but hurdles to approval for these combinations will be higher than for single-component adjuvants. The future regulatory performance of GSKs AS04 will have a crucial impact on the prospects of such combination approaches.

Most available licensed adjuvants, such as alum and MF59, stimulate a strong Th2 response, making them unsuitable for a large number of indications requiring a CTL-mediated immune responses. Novel adjuvants could significantly improve the prospects of vaccine development in indications with a high unmet need, including cancer and tuberculosis.

Key reasons to purchase this title

– Review profiles and clinical data of key adjuvants both marketed and in clinical development and assess their future potential

– Gain insight into the current state of the vaccine adjuvant industry and its future chances and challenges

– Understand regulatory hurdles and develop strategies to maximize chances of approval for novel adjuvants

Key Topics Covered:

CHAPTER 1 EXECUTIVE SUMMARY

Strategic scoping and focus

Insight into the disease market

Related reports

Upcoming related reports

CHAPTER 2 THE VALUE PROPOSITION FOR VACCINE ADJUVANTS

Why are adjuvants needed?

Vaccination triggers a complex immune response cascade

Adjuvants have a key role in increasing the immunogenicity of vaccination

Brief history of adjuvant development

Adjuvants can be split into two groups, based on their dominant mechanism of action

For vaccine manufacturers, adjuvant development brings significant challenges

CHAPTER 3 REGULATORY SITUATION FOR ADJUVANTS

History – only four adjuvants have been approved in the seven major markets (7MM) so far

Safety and reactogenicity of novel adjuvants will form the key part of the FDAs decisions about approval

Several key considerations may facilitate gaining FDA approval for novel adjuvants

CHAPTER 4 ADJUVANT PROFILES

TLR-independent adjuvants – delivery systems

Mechanism

Alum

Profile

Efficacy and safety

Assessment

Oil-in-water emulsions

MF59 (Novartis)

Profile

Efficacy and safety

Assessment

AS03 (GlaxoSmithKline)

Profile

Efficacy and safety data

Assessment

Advax (Vaxine Pty)

Profile

Partnerships and licensing deals

Efficacy and safety data

Assessment

Saponins/ISCOMs (immunostimulating complexes)

QS-21

ISCOMs

Liposomes

TLR-dependent adjuvants – immune potentiators

TLR-agonists can trigger both innate and adaptive immunity

Only few TLR types are targeted by vaccine adjuvants

TLR9 agonists activate both innate and adaptive immunity

TLR3 is a receptor for double-stranded RNA

TLR4 agonists stimulate inflammation

Flagellin is the only known TLR5 ligand

A multitude of TLR-dependent adjuvant candidates are in clinical development

MPL-based adjuvants

AS01

AS02

AS04

RC-529 (Dynavax)

Profile

Partnerships and licensing deals

Efficacy and safety data

Assessment

Flagellin (VaxInnate)

Profile

Partnerships and licensing deals

Clinical and safety data

Assessment

TLR-agonists (Idera Pharma/Merck & Co)

Profile

Partnerships and licensing deals

Clinical and safety data

Assessment

CpG 7909 (Pfizer)

Profile

Partnerships and licensing deals

Clinical data

Safety data

Assessment

IC31 (Intercell)

Profile

Partnerships and licensing deals

Clinical and safety data

Assessment

ISS (Dynavax)

Profile

Partnerships and licensing deals

Efficacy and safety data

Assessment

BIBLIOGRAPHY

Literature

APPENDIX

Contributing experts

Academic key opinion leaders

Industry key opinion leaders

Report methodology

List of Tables

Table 1: Key present and past links between Big Pharma and novel adjuvants

Table 2: Key TLR-independent adjuvants in development for prophylactic vaccines

Table 3: MF59: key facts, 2008

Table 4: AS03: key facts, 2008

Table 5: Advax: key facts, 2008

Table 6: Advax – deals and alliances overview, 2008

Table 7: TLR types, natural ligands and adjuvant strategies

Table 8: Key TLR-dependent adjuvants in development for prophylactic vaccines, 2008

Table 9: Key TLR-dependent adjuvants in development for therapeutic indications, 2008

Table 10: AS01: key facts, 2008

Table 11: AS02: key facts, 2008

Table 12: AS04: key facts, 2008

Table 13: RC-529: key facts, 2008

Table 14: RC-529 – deals and alliances overview, 2008

Table 15: Flagellin: key facts, 2008

Table 16: VaxInnates TLR technology – deals and alliances overview, 2008

Table 17: TLR agonists (Idera): key facts, 2008

Table 18: Ideras TLR technology – deals and alliances overview, 2008

Table 19: CpG 7909: key facts, 2008

Table 20: CpG 7909 – deals and alliances overview, 2008

Table 21: IC31: key facts, 2008

Table 22: IC31 – deals and alliances overview, 2008

Table 23: ISS: key facts, 2008

Table 24: ISS technology – deals and alliances overview, 2008

List of Figures

Figure 1: Overview of immune responses after vaccination or infection

Figure 2: Promising indications for vaccine adjuvants

Figure 3: Milestones in adjuvant development

Figure 4: Adjuvant classes used in marketed and pipeline vaccines

Figure 5: Drivers and resistors for adjuvant development

Figure 6: Strategies to maximize chances for the FDA approval for novel adjuvants

Figure 7: Efficacy of MF59-adjuvanted influenza vaccine versus non-adjuvanted influenza vaccine in elderly with or without underlying chronic disease

Figure 8: CpG 7909 – rapid seroconversion in combination with Engerix-B in healthy patients

For more information visit http://www.researchandmarkets.com/research/e1ceb5/stakeholder_opinio.

Source: Datamonitor




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