Innovations and Opportunities in Therapeutic Vaccines: Technology platforms, key players, and early pipeline candidates

Date: July 22, 2010
Pages: 261
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US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: I6C1CECAEE8EN
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Innovations and Opportunities in Therapeutic Vaccines: Technology platforms, key players, and early pipeline candidates
Therapeutic vaccines promise a new wave of highly potent and highly specific therapeutic agents designed to work in harmony with patients’ own immune systems. Recent advances in the understanding of the human immune system and in technical capabilities have allowed vaccines to move beyond pre-emptive (prophylactic) immunization and into treatment of established diseases. In April 2010, Dendreon’s Provenge became the first ever cancer vaccine to be approved by the US Food and Drug Administration (FDA), overcoming skepticism in the investment community and paving the way for a new generation of biological therapies.

This report explains what therapeutic vaccines are, how they work, and why drug developers around the world are using this approach to address everything from allergies to literally every kind of cancer. More than 70 new proprietary technologies are named and explained, with details of licensing deals and intellectual property positions.

The newest wave of drug candidates based on these technologies can be seen in more than 130 early pipeline candidates, each based on a commercial company or research institute known to have carried out preclinical and/or Phase I trials of at least one therapeutic vaccine candidate in the past year. By way of background, later stage candidates being developed by the same companies are also discussed. In total, more than 270 therapeutic vaccine candidates are identified in this report. Finally, prospects and challenges for the future of this field are discussed, with opinions from around 20 prominent industry leaders and academic researchers.

Key features of this report
  • ‘Beginners guide’ to vaccines and the human immune system, illustrated with original full-color diagrams, to show the potential challenges and benefits of therapeutic vaccination.
  • More than 70 descriptions of proprietary technologies currently in use around the world to design, produce and administer therapeutic vaccines.
  • A comprehensive guide to companies around the world that are currently developing brand new therapeutic vaccines (i.e. candidates in preclinical or Phase I clinical trials).
  • Details of more than 270 specific vaccine candidates, in development by around 120 different companies and research institutes.
  • Expert opinions on the opportunities, challenges and future trends in the monoclonal antibody field from around 20 industry leaders and academic researchers, over a dozen of whom were contacted directly and interviewed for this report.
Scope of this report
  • Understand the basic qualities of vaccines and how these qualities translate into unique medical and commercial features for therapeutic candidates.
  • Appreciate the challenges and risks of therapeutic vaccines, as well as their promise.
  • Assess emerging technologies for possible investment or in-licensing.
  • Identify which companies are involved in this field, and what they are doing.
  • Predict the kinds of drug that may reach the market over the next ten years.
  • Tailor your own company’s strategies to take advantage of upcoming opportunities, such as the validation of new technologies in human patients.
Key Market Issues
  • Therapeutic vaccines hold the potential to address diseases with a high unmet need for effective, i.e. markets that are currently under-penetrated.
  • Much like monoclonal antibodies, the inherent specificity of vaccines may shorten drug development times and increase rates of success in preclinical and clinical trials, now that the intricacies of the human immune system are better understood.
  • The recent US approval of Dendreon’s personalized cancer vaccine Provenge has established a precedent and a recognized path to regulatory approval for therapeutic vaccines.
  • Newer technologies target the same basic immune system processes as Provenge, but may result in cheaper and more broadly applicable therapies.
Key findings from this report
  • New technical capabilities and better understanding of the human immune system has recently allowed vaccination approaches to be applied to therapeutic settings as well as prophylaxis.
  • Demand for therapeutic vaccines is high, and profits from launched drugs are expected to achieve ‘blockbuster’ levels (billions of US dollars per annum).
  • Treatment of established diseases requires different immune reactions to protective (prophylactic) immunity, to overcome existing disease burdens and immuno-avoidance mechanisms, so immune responses must be ‘modulated’ rather than just stimulated.
  • Many new candidates use multiple ‘antigen’ targets, or multiple variants of a single target, to address heterogeneity in both disease targets and patients’ immune systems.
  • Vaccine approaches can also be used to inhibit immune responses to specific ‘antigens’, making them useful for treating allergies, autoimmune diseases and transplant rejection.
  • Various vectors (carriers) and adjuvants (immunostimulators), each with their own benefits and drawbacks, are being used to enhance the delivery of vaccine antigens to target immune cells and to modulate the strength and type of immune responses that result.
Key questions answered
  • What are therapeutic vaccines, and what can they do?
  • Why are so many companies and research institutes working on therapeutic vaccines?
  • Which companies are currently working to validate and develop the latest generation of drug candidates based on therapeutic vaccines?
  • What technological and regulatory challenges face these companies in developing such candidates and bringing them to market?
  • What technologies are being used to design, produce and administer these drug candidates?
  • Who developed these technologies, and who is using them right now?
Innovations and Opportunities in Therapeutic Vaccines
Executive summary
An introduction to therapeutic vaccines
Vaccines comprising unlinked polypeptide antigens
Peptide antigens linked to polypeptide carrier/adjuvant molecules
Delivery of peptide antigens using particulate carriers
DNA vaccines
Recombinant viruses as vaccines
Cell-based vaccines

CHAPTER 1 AN INTRODUCTION TO THERAPEUTIC VACCINES

Summary
Introduction
Vaccination
Therapeutic vaccination
Specificity
Potency
Convenience and cost
Challenges for therapeutic vaccines
Disease burden
Immunosuppression
Immuno-avoidance
Examples of therapeutic vaccines already approved for sale/manufacture
Rabies vaccines
Allergy vaccines
Alutard SQ
Grazax
Chanllergen
Multiple sclerosis immunotherapy
BCG vaccines as immunotherapies for cancers
TheraCys
OncoTICE
PACIS
Vaccines containing cancer antigens
Melacine
MVax
CreaVax-RCC
Oncophage
Provenge
OncoVAX
Conclusions

CHAPTER 2 VACCINES COMPRISING UNLINKED POLYPEPTIDE ANTIGENS

Summary
Introduction
Technology platforms
Polyvalent Vaccines
Tolerogenic vaccines
Apitopes
ToleroMune
Tregitopes
Complementary peptides
Bionor Immuno peptide design
TUMAPs
magnICON
ImmuNovo platforms
PepTcell epitope prediction
Variosite
Optimized cryptic peptides
iAPA
Early pipeline vaccine candidates
ALK-Abell?
Apitope
Axon Neuroscience
Bayer Innovation
BioArctic Neuroscience
Bionor Immuno
BioSidus
CIGB
Circassia
CSL
CuraVac
EpiVax
Genovax
Green Peptide
GSK
Helicure
iBio
Immatics
ImmunoCellular Therapeutics
Immunotope
Immunovaccine
ImmunoVentis
ImmuNovo
Intercell
Juvaris
MabVax
Multimmune
OncoTherapy Science
Paladin Labs
PepTcell
Pfizer
Profectus
PSMA Development Co
Shionogi
Variation Biotech
Vaxine Pty Ltd
Vaxon
VaxOnco
Conclusions
Antigenicity
Target antigen(s)
Tolerance
Production

CHAPTER 3 PEPTIDE ANTIGENS LINKED TO POLYPEPTIDE CARRIER/ADJUVANT MOLECULES

Summary
Introduction
Technology platforms
Haptenization
Mimotopes
AFFiTOME
ADX40
ImmunoBodies
APC targeting mAb-vaccines
Vaccibodies
ApoVax
Ii Key Hybrid
LEAPS
HSP technology
ASIT+
CyaA
ImmuCcine
Kinoid vaccines
UBITh
Early pipeline vaccine candidates
AFFiRiS
Antigen Express
Antigenics
ApoImmune
Aracl?n Biotech
Aster Biopharmaceuticals
BioTech Tools
Braasch Biotech
Cancer Research UK
CEL-SCI
Celldex
Genticel
GSK
Immunotech Labs
Immunovative Therapies
Kancer Ltd
Neovacs
Pfizer
Pro-Cure
Recopharma
SJ Biomed
UBI
Vaccibody AS
Conclusions

CHAPTER 4 DELIVERY OF PEPTIDE ANTIGENS USING PARTICULATE CARRIERS

Summary
Introduction
Technology platforms
SupraAntigen
ImuXen
Lipotek platforms
Virosomes
Virus-like particles
CVLPs
HCV VLPs
Schiller and Chackerian
Auto-antibody drugs
Immunodrugs
WHcAg VLPs
PREPs
Versamune
CHP Technology
DCtag
pMHC-NP
Cellarium
Early pipeline vaccine candidates
AC Immune
C-Pharma
Cytos
Dendright
Henderson Morely
ImmunoFrontier
InCytu
Lentigen
Lipotek
Lipoxen
Oncothyreon
Panvax
Parvus Therapeutics
PDS Biotech
Pevion
Select Vaccines
VLP Biotech
Conclusions

CHAPTER 5 DNA VACCINES

Summary
Introduction
Technology platforms
Ii suppression
BHT-DNA
ANTIGENeering
Peptide-Derivatized Dendrimers
IL-12M
TriGrid
LAMP-vax
SynCon
ProfectusVAX
ImuXen
Early pipeline vaccine candidates
Antigen Express
Bayhill Therapeutics
CIGB
Genetic Immunity
Genexine
Genovax
GeoVax
Ichor
ImmunoFrontier
ImmunoGenetix
Immunomic Therapeutics
Inovio
Karolinska Institute
Lipoxen
Merck & Co
Profectus
Scancell
University of Miami
University of Southampton
Vaccibody AS
Vical
ViroMed
Conclusions

CHAPTER 6 RECOMBINANT VIRUSES AS VACCINES

Summary
Introduction
Technology platforms
Alphavaccine
MVA-BN
Chimpanzee adenovirus vectors
Theravax
Co-X-Gene
ProfectusVAX
IBDV
Early pipeline vaccine candidates
AlphaVax
BN ImmunoTherapeutics
Crucell
Genexine
GenPhar
GeoVax
Okairos
Profectus
PSMA Development Co
Transgene SA
TSD Japan
Vaxin Inc
VectorLogics
Virax
Conclusions
Safety concerns
Immunogenicity

CHAPTER 7 CELL-BASED VACCINES

Summary
Introduction
Technology platforms
Advaxis’ Listeria platform
Aduro BioTech’s Listeria platforms
?terna Zentaris bacterial carrier system
Tarmogens
Autologous dendritic cells
iAPA
DCVax
HS System
HyperAcute Immunotherapies
TGF-? antisense technology
ImmuneFx
OPALs
Early pipeline vaccine candidates
Aduro BioTech
Advaxis
?terna Zentaris
Cadila Pharmaceuticals
Celprogen
Creagene
Dendreon
Entest
Geron
GlobeImmune
Gradalis
Heat Biologics
ImmunoCellular Therapeutics
ImmunoVentis
King’s College, London
Morphogenesis
Multimmune
Newcastle University
NewLink Genetics
Northwest Biotherapeutics
NovaRx
OPAL Therapeutics
Pique Therapeutics
University of Queensland
VaxOnco
Conclusions
Microbial cells
Diseased or disease-mimicking cells
Dendritic cell vaccines
The future of therapeutic vaccines
Appendix
Primary research methodology
Glossary
Index
References

LIST OF FIGURES

Figure 2.1: Antigen presentation by MHC class I
Figure 2.2: Antigen presentation by MHC class II
Figure 2.3: ARM treatment of autoimmune disease
Figure 3.4: Immunobody activation of T-helper cells
Figure 3.5: An example of a Vaccibody
Figure 3.6: An Ii Key Hybrid
Figure 7.7: Tarmogen vaccination

LIST OF TABLES

Table 2.1: Therapeutic vaccine candidates containing unlinked polypeptide antigens
Table 2.2: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 1)
Table 2.3: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 2)
Table 2.4: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 3)
Table 2.5: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 4)
Table 2.6: Therapeutic vaccine candidates containing unlinked polypeptide antigens (ctd 5)
Table 3.7: Therapeutic vaccine candidates containing peptide antigens linked to polypeptide carriers/adjuvant molecules
Table 3.8: Therapeutic vaccine candidates containing peptide antigens linked to polypeptide carriers/adjuvant molecules (ctd 1)
Table 3.9: Therapeutic vaccine candidates containing peptide antigens linked to polypeptide carriers/adjuvant molecules (ctd 2)
Table 4.10: Therapeutic vaccine candidates using simple particulate carriers
Table 4.11: Therapeutic vaccine candidates using simple particulate carriers (ctd)
Table 5.12: Therapeutic DNA vaccine candidates
Table 5.13: Therapeutic DNA vaccine candidates (ctd 1)
Table 5.14: Therapeutic DNA vaccine candidates (ctd 2)
Table 6.15: Therapeutic vaccine candidates comprising recombinant viruses
Table 6.16: Therapeutic vaccine candidates comprising recombinant viruses (ctd)
Table 7.17: Therapeutic cell-based vaccine candidates
Table 7.18: Therapeutic cell-based vaccine candidates (ctd 1)
Table 7.19: Therapeutic cell-based vaccine candidates (ctd 2)
Table 7.20: Therapeutic cell-based vaccine candidates (ctd 3)
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