Cancer Vaccine Developments to 2013

Publication Date	September 2007
Publisher	Espicom
Product Type	Report
Pages	184
ISBN Number	978-1-85822-295-0
Product Code	ESP00119

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Summary

Who are the players and products in the race to launch? This report critically assesses the candidates in their wider market context, providing a complete review of the market and its likely development to 2013. The launch of Sanofi Pasteur MSD's Gardasil and GSK's Cervarix has propelled cancer vaccines from research obscurity to a key area of commercial and clinical interest. But can the sector capitalise on these gains and really fulfil its promise?

By 2010, the global cancer market is expected to generate sales in excess of US$60 billion due to growth in the sales of existing innovative products and the launch of nearly 60 new products which will account for around 30% of total drug launches.

But where do cancer vaccines fit into this outlook? At present, prophylactic vaccines dominate the cancer vaccine sector following the recent launches of Sanofi Pasteur MSD's Gardasil and GlaxoSmithKline's Cervarix. We expect that sales of these vaccines will break through US$4 billion by 2011. While there is no therapeutic vaccine market, so to speak of, at present, it has the potential to mirror the growth seen in the monoclonal antibody market, and reach sales in excess of US$5 billion by 2012. This prediction may be optimistic and is highly dependent on vaccines being approved for major cancer indications - no small challenge taking the development history of the sector.

While no new therapeutic cancer vaccine has been approved recently the product pipeline has changed substantially, shifting from one filled with vaccines at the Phase I and II stage, to a more mature pipeline reflecting a shift in development towards the later stages. This is a consequence, not only of the age of the pipeline, but of the difficulties and pitfalls that therapeutic cancer vaccine development faces. Many vaccines have fallen by the wayside for one reason or another. Indeed the rush to join this area of research has waned slightly with the realisation that products are harder to bring to market than first anticipated. Cancers covered

Brain
Breast
Gastrointestinal
Genito-urinary
Gynaecological
Haematological
Lung
Melanoma/Sarcoma

Types of cancer vaccine

Antigen/adjuvant vaccines
Whole-cell tumour vaccines
Dendritic cell vaccines
Viral vectors and DNA vaccines
Idiotype vaccines.

Content

Executive summary
Introduction
What is a cancer vaccine?
Prophylactic vaccines
Overview
Limitations
Therapeutic vaccines
Overview
Ag/adjuvant vaccines
Whole cell tumour vaccines
Dendritic cell vaccines
Viral vectors and DNA vaccines
DNA vaccines
Vector-based vaccines
Idiotype vaccines
Antigens
Carcinoembryonic antigen
Ganglioside molecules
Heat shock proteins
MART-1
MUC1
NY-ESO-1
Prostate specific antigen
Sialyl Tn
Telomerase
Tyrosinase
Adjuvants
AS04
Bacillus Calmette Guerin
Interleukins
Granulocyte monocyte-colony stimulating factor
Incomplete Freund's adjuvant
Keyhole limpet hemocyanin
Montanide ISA-51
QS-21
Monitoring the immune response
Proliferation
Peptide-major histocompatibility complex multimers
ELIS pot
Intracellular cytokine assays
Challenges of developing vaccines
General challenges
Antigen selection
Adjuvants
Generating the correct immune response
Long-term immune memory
Cancer-vaccine specific challenges
Function of thymus
Heterogeneity in immune responses
Evasion of immune system
Tumour-induced immunosuppression
Induction of autoimmunity
Product standardisation and characterisation
Market future
Potential targets
Tumour types
Disease incidence
Disease settings
Combination therapy
Clinical trial designs
Proposed clinical trial design
Endpoints
Patient selection
Survival
Other time-to-event endpoints
Response rate
Endpoint modifications
Patient-reported outcomes and quality-of-life endpoints
Biologic markers
Regulatory challenges
Market leaders
Cost effectiveness
Market growth
Potential market size
Competition
Cervical cancer vaccines: novel challenges
HPV vaccines
Gardasil
Cervarix
Vaccination population
Australia
Canada
Europe
Belgium
France
Switzerland
US
Vaccine cost
US Government immunisation schemes
European reimbursement
Sweden
UK
Less developed countries
Safety issues
Screening
Future research
Major agree ments
The advantage of collaboration
The Biomira and Merck KGaA story
Stimuvax
The Geron and Merck & Co story
GRNVAC 1
The GSK and Ludwig Institute for Cancer Research story
MA GE-A3
The Oxford BioMedica and sanofi-aventis story
TroVax
The Roche and Transgene story
TG4001
Terminated agreements: big pharma burns its fingers
Canvaxin
CancerVax and Serono
The agreement
Why did the agreement end?
Melacine
Corixa and Schering-Plough
The agreement
Why did the agreement end?
GMK Vaccine
Progenics Pharmaceuticals and Bristol-Myers Squibb
The agreement
Why did the agreement end?
Insegia
Aphton and sanofi pasteur
The agreement
Why did the agreement end?
Theratope
Biomira and Merck KGaA
The agreement
Why did the agreement end?
Faile d cancer vaccines
Cancer vaccines that have failed in Phase II /III development
Canvaxin failure leads to CancerVax merger
Product history
Why did the vaccine fail?
GMK Vaccine loses BMS backing following inferior results
Product history
Why did the vaccine fail?
GVAX highlights limits of patient-specific vaccines
Product history
Why did the vaccine fail?
Insegia problems force Aphton's bankruptcy
Product history
Why did the vaccine fail?
Melacine; launched and disappeared
Product history
Why did the vaccine fail?
PANVAC-VF failure forces liquidation of Therion
Product history
Why did the vaccine fail?
Early Reniale data still waiting for confirmation
Product history
Why did the vaccine fail?
Theratope disappointment wards off Merck
Product history
Why did the vaccine fail?
Launche d products
Vaccines currently on the market
OncoVAX
Intracel
The market(s)
The technology
Results to date
M-Vax
AVAX Technologies
The market(s)
The technology
Results to date
Gardasil
Sanofi Pasteur MSD
The market(s)
The technology
Results to date
Cervarix
GlaxoSmithKline
The market(s)
The technology
Results to date
Estimated sales
Gardasil
Sanofi Pasteur MSD (sanofi-aventis' joint venture with Merck & Co)
Sales forecasts and assumptions
Cervarix
GlaxoSmithKline
Sales forecasts and assumptions
Vaccines in devel opment
Key launches
Breast cancer
Overview
Why is vaccine therapy being explored for breast cancer?
Vaccines in Phase II development
Vaccines in Phase I development
Vaccines of interest
AE37
dHER2 vaccine
NeuVax
Haematological cancer
Overview
Why is vaccine therapy being explored for non-Hodgkin's lymphoma?
Why is vaccine therapy being explored for leukaemia?
Vaccines in Phase II development
Vaccines in Phase II development
Vaccines in Phase I development
BiovaxID
Biovest International (Accentia Biopharmaceuticals)
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
FavId
Favrille
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
MyVax
Genitope
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
PR1 vaccine
The Vaccine Company
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
Oncophage
Lung cancer
Overview
Why is vaccine therapy being explored for lung cancer?
Vaccines in Phase II development
Vaccines in Phase II development
Vaccines in Phase I development
Lucanix
NovaRx
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
MAGE-A3
GlaxoSmithKline
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
Stimuvax
Biomira/Merck KGaA
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
IDM -2101
IN GN 225
Genito-urinary cancer
Overview
Why is vaccine therapy being explored for prostate cancer?
Why is vaccine therapy being explored for renal cell carcinoma?
Vaccines in Phase II development
Vaccines in Phase II development
Vaccines in Phase I development
DCVax-Prostate
Northwest Biotherapeutics
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
GVAX vaccine
Cell Genesys
The technology
Pivotal trials
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
Oncophage
Antigenics
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
Provenge
Dendreon
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
TroVax
Oxford BioMedica/sanofi-aventis
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
GRNVAC 1
Onyvax-P
Reniale
Gynaecological cancer
Overview
Why is vaccine therapy being explored for ovarian cancer?
Vaccines in Phase II development
Vaccines in Phase II development
Vaccines in Phase I development
Amolimogene
MGI Pharma
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
TG4001
Transgene/Roche
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
CV ac
HspE7
Gastrointestinal cancer
Overview
Why is vaccine therapy being explored for pancreatic cancer?
Why is vaccine therapy being explored for colorectal cancer?
Vaccines in Phase II development
Vaccines in Phase II development
Vaccines in Phase I development
GV1001
Pharmexa
The technology
Pivotal trials
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
OncoVAX
Intracel
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
TroVax
Oxford BioMedica/sanofi-aventis
The technology
Other important trials
Results to date
Phase II results of TroVax plus CT in CRC
Phase II results of TroVax adjuvant therapy in CRC
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
Avicine
Gastrimmune
Oncophage
Brain cancer
Overview
Why is vaccine therapy being explored for brain cancer?
Vaccines in Phase II development
Vaccines in Phase I development
CDX-110
Celldex Therapeutics
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
DCVax-Brain
Northwest Biotherapeutics
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
Oncophage
Mel anoma/sarcoma
Overview
Why is vaccine therapy being explored for melanoma?
Vaccines in Phase II development
Vaccines in Phase II development
Vaccines in Phase I development
Allovectin-7
Vical
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
MDX-1379
Medarex/Bristol-Myers Squibb
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Agreements
Market size
Competitors
Analysis
Strengths
Weaknesses
M-Vax
AVAX Technologies
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
Oncophage
Antigenics
The technology
Pivotal trial
Other important trials
Results to date
Next major event/milestone
Market size
Competitors
Analysis
Strengths
Weaknesses
Other vaccines of interest
Uvidem
Othe r vaccines
Overview
Vaccines in Phase II development
Vaccines in Phase I development
Sources
Espicom sources
Others
List of Tables
- Table 1. Infectious agents involved in cancer
- Table 2. Proposed clinical trial designs for cancer vaccines
- Table 3. Agreements that could shape the cancer vaccine market
- Table 4. Terminated agreements between biotech companies and big pharma
- Table 5. Major cancer vaccine failures
- Table 6. Insegia Phase III results showing survival by Ab response
- Table 7. Vaccines currently on the market
- Table 8. Sales forecast for Gardasil
- Table 9. Sales forecast for Cervarix
- Table 10. Who's developing what in Phase II/III?
- Table 11. Key vaccine launches to 2013
- Table 12. Vaccines in Phase II development for breast cancer
- Table 13. Vaccines in Phase I development for breast cancer
- Table 14. Vaccines in Phase III development for haematological cancers
- Table 15. Vaccines in Phase II development for haematological cancers
- Table 16. Vaccines in Phase I development for haematological cancers
- Table 17. Vaccines in Phase III development for lung cancer
- Table 18. Vaccines in Phase II development for lung cancer
- Table 19. Vaccines in Phase I development for lung cancer
- Table 20. Vaccines in Phase III development for genito-urinary cancers
- Table 21. Vaccines in Phase II development for genito-urinary cancers
- Table 22. Vaccines in Phase I development for genito-urinary cancers
- Table 23. Vaccines in Phase III development for gynaecological cancers
- Table 24. Vaccines in Phase II development for gynaecological cancers
- Table 25. Vaccines in Phase I development for gynaecological cancers
- Table 26. Vaccines in Phase III development for gastrointestinal cancers
- Table 27. Vaccines in Phase II development for gastrointestinal cancers
- Table 28. Vaccines in Phase I development for gastrointestinal cancers
- Table 29. Vaccines in Phase II development for brain cancer
- Table 30. Vaccines in Phase I development for brain cancer
- Table 31. Vaccines in Phase III development for melanoma/sarcoma
- Table 32. Vaccines in Phase II development for melanoma/sarcoma
- Table 33. Vaccines in Phase I development for melanoma/sarcoma
- Table 34. Vaccines in Phase II development for other cancers
- Table 35. Vaccines in Phase I development for other cancers
List of Figures
- Figure 1. Potential advantages of therapeutic vaccines for cancer
- Figure 2. Vaccines in Phase II/III development by vaccine type
- Figure 3. Vaccines in Phase II/III development by indication
- Figure 4. US cancer statistics
- Figure 5. Potential combination therapy with cancer vaccines
- Figure 6. Vaccines in Phase II/III development by company
- Figure 7. Factors faced by vaccines from their competitors
- Figure 8. Growth drivers and resistors in the therapeutic cancer vaccine market
- Figure 9. Issues faced by human papillomavirus vaccines
- Figure 10. The benefits of collaboration
- Figure 11. Reasons why cancer vaccines may have failed in clinical trials
- Figure 12. Key vaccine launches by indication
- Figure 13. Key vaccine launches by vaccine type
- Figure 14. Development phase breakdown for breast cancer
- Figure 15. Vaccine type breakdown for breast cancer
- Figure 16. Development phase breakdown for haematological cancer
- Figure 17. Vaccine type breakdown for haematological cancer
- Figure 18. The process involved in manufacturing BiovaxID
- Figure 19. The process involved in manufacturing FavId
- Figure 20. The process involved in manufacturing MyVax
- Figure 21. Development phase breakdown for lung cancer
- Figure 22. Vaccine type breakdown for lung cancer
- Figure 23. Development phase breakdown for genito-urinary cancer
- Figure 24. Vaccine type breakdown for genito-urinary cancer
- Figure 25. Development phase breakdown for gynaecological cancer
- Figure 26. Vaccine type breakdown for gynaecological cancer
- Figure 27. Development phase breakdown for gastrointestinal cancer
- Figure 28. Vaccine type breakdown for gastrointestinal cancer
- Figure 29. Development phase breakdown for brain cancer
- Figure 30. Vaccine type breakdown for brain cancer
- Figure 31. Development phase breakdown for melanoma/sarcoma
- Figure 32. Vaccine type breakdown for melanoma/sarcoma