9.05

Combinatorial cancer vaccines: How to enhance potency of cancer vaccines

• Rationally design antigens to break tolerance to self proteins
• Immune modulation: Enhance immune potency by amplifying immune response
• Targeting tumor mediated immune suppression

Dr Karin Jooss, Head of Cancer Vaccines, Pfizer Global R&D

9.25

Questions & discussion

9.30

Short presentations & panel discussion
What are the recent advances in B cell and antibody approaches to AI, and how are they being used to inform decisions in different disease areas?

• Optimising antibody response: How to get high enough levels in certain indications
  - Alzheimer’s
  - Crohn’s disease
  - Arthritis
  - Substance abuse
  - Cancer
• Dosing issues
• Application of biomarkers
• Regulatory interaction
• To what extent is there a blurring of boundaries between AI and passive immunotherapeutics / MaBs?

Panellists:
Dr Martin Bachmann, CSO, Cytos Biotechnology AG
Carlos F. Santos, PhD, CSO & Vice President, Product Development, Accentia Biopharmaceuticals / Biovest International

10.25

Morning coffee in the exhibition area

11.05

Case study
BiTE: Marrying antibody and T cell therapy of cancer

• BiTE: a unique T-cell engaging antibody format
• Clinical proof of concept achieved in NHL and ALL with CD19-specific BiTE antibody blinatumomab
• EpCAM-specific BiTE antibody MT110 in clinical trial with solid tumour patients
• Emerging pipeline of BiTE antibodies in collaboration with strong pharma partners
• Well understood mode of BiTE action
• Activity of cetuximab-based BiTE antibody against KRAS and BRAF mutated colorectal cancer cells

Markus Muenz, Group Leader, EpCAM Research, Micromet AG

11.25

Overcoming immune inhibitory pathways with cancer vaccine approaches

• Identification of dominant inhibitory pathways may provide rationale for selecting the most appropriate immune-modulator - these may be cancer and cancer-stage specific
• Using biomarkers of immune inhibition to increase the likelihood of generating meaningful anti-tumour response through combination of strategies to present tumour antigen to the immune system and appropriate immune modulation
• Multiple immune modulators can be considered but need to be selected rationally based upon disease and stage of disease
• Optimal clinical strategies to evaluate combination therapies and to maximize likelihood of success

Neil L. Berinstein MD, Chief Scientific Officer, IRX Therapeutics

11.45

Panel discussion
Adjuvants and other agents: Do you need them?

• AIs have not reached maximum efficacy yet – would novel adjuvants be the answer? Or is the answer it to find out how to fight active immunosuppression?
• What are the various mechanisms of action and how might they be applied in AI? eg
  • Anti CTLA4
  • Anti-PD1
  • Anti-41BB
• Striving for better biomarkers to understand how adjuvants drive the immune system
• What is the regulatory viewpoint on adjuvants for AIs – what is the risk:benefit?
• Many of these adjuvants and other agents have been in clinic for a while: Will they have utility on their own?
• What can you do locally and combine with systemic immunity?
  • How to combine early to optimise utility
• What examples are there of adjuvants / other agenda to supplement / complement AI approaches: Applications in cancer vaccines, infectious diseases and elsewhere

Panellists:
Dr Habib Fakhrai, Executive Vice Chairman of the Board & CSO, NovaRX
Pierre Vandepapelière, MD, PhD, Chief Medical Officer, Neovacs SA
Professor Angus Dalgleish, Professor of Oncology, St George's, University of London

12.25

Buffet lunch in the exhibition area

Immune monitoring for clinical efficacy: How do you measure and monitor the potency of AI response in the clinic?

• What are the secondary measures to prove that AI is having an effect (eg other than tumour shrinkage in cancer vaccines)?

1.35

Case studies: active immunotherapeutics against self (cytokines: TNFa and IFNa) and non-self (infectious (HBV)) antigens

• How might the data collected in early clinical trials guide optimal regimen, for later stage clinical trials, and support registration?
• What evidence is there that immune response correlates to clinical benefit: are immune related response criteria the holy grail or should we develop other tools?
• What assays and methods have been found to work eg
  • ex vivo assays
  • Genotype assays
  • Phenotype assays
  • Beyond elispot

Pierre Vandepapelière, MD, PhD, Chief Medical Officer, Neovacs SA

1.55

Questions & discussion

2.00

Case study
Developing a potency assay for a variable component of the autologous, protein based therapeutic cancer vaccine, Oncophage: What potency is required for release of the product?

• Challenges of developing cancer vaccine potency assays when immune correlates of clinical responses are not known
• How can requirements for quantitative information on active ingredient be reconciled with inherent variability in the active ingredient?
• How does one define a correlation between cancer vaccine potency and clinical effect in absence of focused regulatory guidelines?

Daniel L. Levey, PhD, Senior Director, Scientific Affairs & Business Development, Antigenics, Inc

2.20

Questions & discussion

2.25

Case study
Developing a well characterised product candidate that optimises potency - ensuring that potency assays are comparable across trials

• Lessons learned from the development of sipuleucel-T for men with castrate-resistant prostate cancer
• Characterization of the product and development of the potency assay
• Correlation of product parameters with laboratory and clinical outcomes

Dr David L. Urdal, CSO, Dendreon Corporation

2.45

Questions & discussion

2.50

Panel discussion
Regulatory guidance: What is the latest from FDA and EMEA on the acceptance of immune monitoring and requirements for potency assays for AI?

• What degree of harmonisation is there between regulatory bodies?
  
• Drawing lessons from infectious diseases and cancer vaccines together

3.25

Chair’s closing summary

3.30

Close of conference followed by afternoon tea in the exhibition area

How are emerging technologies and approaches – in particular T reg cells - enabling the move into these new therapeutic targets?
Where are tolerizing vaccine strategies showing greatest signs of advancement?

• Diabetes
• MS

Which areas are showing progress?

• Anti GLA
• Anti CTLA-4
• TNF receptors

What are the safety and regulatory pathways?
What combinations therapies are being looked into?

1.30

Case study
Advances in DNA vaccines for autoimmune diseases: clinical results

• Promising results from two clinical trials with DNA vaccines
  • BHT-3021 for type 1 diabetes
  • BHT-3009 for multiple sclerosis
• Is there evidence for Treg induction by DNA vaccines?
• Applicability to other disease areas

Hideki Garren, MD, PhD, Executive Vice President, COO, CSO & Co-Founder,
Bayhill Therapeutics

1.50

Questions & discussion

1.55

Case study
Vaccination against type II diabetes

• Anti-Il-1b vaccination
• Preclinical and first clinical data
• Cytokine neutralisation

Dr Martin Bachmann, CSO, Cytos Biotechnology AG

2.15

Questions & discussion

AI for allergy: What breakthroughs and barriers has this group encountered and what are their next steps?

2.20

Case study
Advances in sublingual immunotherapy of respiratory allergies

• Antigen-specific tolerance induction in humans
• Specifics of the oral immune system
• Comparison between the subcutaneous and the sublingual routes of immunotherapy
• Tolerance induction beyond regulatory T cells - adjuvants and vector systems for the sublingual route

Philippe Moingeon PhD, Vice President, R&D, Stallergenes SA

2.40

Questions & discussion

2.45

Case study
Next generation vaccines in allergic disorders

• Translational research based identification of new biomarkers for allergic disease and clinical efficacy
• Rational vaccine design with well characterised mode-of-action and improved immunisation schedules and dosage
• Primary prevention of asthma and expanded use to new unmet needs

Poul Sørensen, PhD, Vice President, Global Research, ALK

3.05

Questions & discussion

3.10

Panel discussion
How can a greater understanding of mechanism of action in these fields be used to inform R&D in the cancer and infectious disease areas?

3.25

Chair’s closing summary

3.30

Close of conference followed by afternoon tea in the exhibition area