9.05

Keynote address
Immuno-oncology: Creating the operating framework for a new era of cancer therapy

• Defining a new path forward for informed development of cancer immunotherapies
• Understand key variables of a new framework:
  • A new development paradigm
  • Reliable use of immunological methods
  • Biomarkers
  • Improved clinical endpoints
  • Scientific publication framework
  • Regulatory and scientific exchange with the community
  • FDA guidance on "Clinical Considerations for Therapeutic Cancer Vaccines"
• Shape the emerging discipline of immuno-oncology

Dr Axel Hoos, Co-Chair, Executive Committee, Cancer Immunotherapy ` Consortium (CIC) & Medical Lead, Ipilimumab Program, Bristol-Myers Squibb

9.25

Questions & discussion

Case studies from companies approaching registration

• What is required for registration trials? Ensuring you have high quality mid to late stage data in the package to support
  - Efficacy
  - Mechanism of action
  - Potency assays
  - Choice of end point
• What are the specific registration challenges for phase III combination trials?
• Highlighting the differences between registration in US / EU
• For those that have failed registration trials –– what would they do differently?

9.35

Characterization of Oncophage, an autologous, protein based therapeutic cancer vaccine: development challenges and solutions

• Development of a cutting edge cancer vaccine in absence of focused regulatory guidelines (Phase 3 trials through submission of MAA)
• Reconciling Oncophage’s unique product attributes with ICH driven characterization requirements
• Challenges associated with demonstration of process consistency
• Consequences of process evolution during Oncophage clinical development

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

9.55

Questions & discussion

10.00

Clinical development of BiovaxID (fNHL-Id) vaccine for Non-Hodgkin's Lymphoma

• The impact of Phase 2 clinical study design on mid-to-late-stage development
• Lessons learned from a tightly-coupled Phase 2/3 development plan
• Adapting to standard-of-care advances during mid-to-late stage development
• Managing the regulatory pathway for an AI therapeutic vaccine across multiple jurisdictions

Carlos F. Santos, PhD, CSO & Vice President, Product Development, Accentia Biopharmaceuticals / Biovest International

10.20

Questions & discussion

10.25

Case study
Stimuvax®, a therapeutic cancer vaccine targeting MUC1: First clinical experience and strategic considerations in NSCLC

• Reviewing pre-clinical and clinical data
• Detailing the pivotal trial
• How has contact with regulatory authorities been managed?
• Thoughts about the application of biomarkers and exploratory medicine

Jens-Peter Marschner, MD, Head, Immunologicals Programs, Global Early & Clinical Development Units Oncology, Merck KGaA

10.45

Regulatory perspectives: Presentations followed by panel discussion

• How have Dendreon and late stage companies helped to change the regulatory paradigm? In what ways does trial design for AI need to be different from traditional cytotoxic drugs?
• As we enter year 2 of the application of the new Advanced Therapies Regulations, what impact has it had from a regulatory decision-making point of view and also in terms of industry decision-making?
• What is the feedback so far?
• How are companies progressing and what might need updating in the guidelines?
• What are the areas for clarification?
• Feedback from the Draft Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines
  • How might it lead to a redefinition of end points and efficacy parameters?
• What are the latest decisions on use of TLRs in AI?
• Minimal residual disease trials: are they the best venue for cancer immunotherapy? How can lead times be reduced?

Panellists:
Dr Thomas Hinz, Head of Section, Therapeutic Vaccines, Paul-Ehrlich-Institut
Dr Samir N. Khleif, Head, Cancer Vaccine Section, NCI
Dr Joyce Frey-Vasconcells, Executive Director, PharmaNet Consulting, PharmaNet Development Group

11.30

Morning coffee in the exhibition area

12.25

Case study
Identifying the right biomarkers

• Broad versus specific biomarkers
• Increasing trend for inflammatory biomarkers

Professor Angus Dalgleish, Professor of Oncology, St George's, University of London

12.45

Questions & discussion

12.50

Case study
Validating potential biomarkers for use in the clinic

• How to correlate biomarkers and clinical end points?
• What data is needed and when? What studies are needed?
• What is there beyond overall survival that will tell you what’s happening in AI?

Dr Jean-Yves Bonnefoy, Vice President, R&D, Transgene SA

1.10

Questions & discussion

1.15

Buffet lunch in the exhibition area

2.25

Discovery and application of predictive biomarkers for MAGE-A3 cancer immunotherapy

• Biomarker discovery in early stage trials with MAGE-A3 antigen specific cancer immunotherapy
• Biological significance of the MAGE-A3 ASCI predictive gene signature
• Challenges for predictive biomarker implementation in late stage clinical studies

Fernando Ulloa-Montoya, PhD, Head of Molecular Biology Technology Group, Cancer Immunotherapy, GlaxoSmithKline Biologicals

2.45

How can handling procedures at the sites, transportation conditions and pre-analytical factors affect the laboratory results? With what impact on biomarker data?

• Why is laboratory data needed for clinical trials?
• Is laboratory quality uniform across labs and countries?
• When are lab results normal or abnormal? Background information for non-medics
• Pre-analytical factors: Role and ways to avoid errors
  • Understanding pre-analytical factors when shipping blood samples to ensure lab results are valid
• Importance of study preparation and site involvement
• Focus on biomarkers: Specific collection materials, temperature control etc.
• Selection criteria: Asking the right questions upfront
  

Dr Hermann Schulz, Chief Executive Officer, INTERLAB central lab services - worldwide GmbH

3.15

Panel discussion
Comparing experiences with EMEA / FDA development procedures for validating biomarkers: What are the similarities / differences in approach?

Panellist:
Dr Thomas Hinz, Head of Section, Therapeutic Vaccines, Paul-Ehrlich-Institut

3.35

Chair’s closing summary

3.40

Afternoon tea in the exhibition area

Case studies focusing on progress with AI for specific chronic infectious diseases

• What is the mechanism of action?
• How is immune response being measured in these studies?
• Preclinical and clinical pathways
• Combination with standard of care

12.05

Immunotherapy of high-risk HPV infections

• Which immune response is needed?
• What is the mode of action of this therapeutic vaccine?
• What are the clinical benefits?
• Apart from patients with VIN 3 which other patients can benefit?

Professor Dr C. J. M. Melief, Professor of Immunology, Department of Immunohematology & Blood Transfusion, Leiden University Medical Center

12.30

Questions & discussion

12.40

An autologous AI approach to treating HIV infection

• Defining the unmet medical need
• Considerations for engineering of the product
• Challenges to efficacy testing in the ART drug era
• Trial design and clinical/immunologic endpoints

Charles A. Nicolette, PhD, Chief Scientific Officer, Vice President, R&D, Argos Therapeutics, Inc

1.05

Questions & discussion

1.15

Buffet lunch in the exhibition area

2.25

The need for a new HCV treatment: Towards a therapeutic vaccine

• HCV and today's standard of care (SoC)
• The pivotal role of T-cells
• Improvement of a T-cell vaccine with a TLR agonist
• Perspectives to combine the vaccine with novel small molecule treatment(s)

Professor Alexander Von Gabain, Strategic Advisor to the Board, Intercell AG

2.45

Questions & discussion

2.50

Creation of ‘T bodies’ against Epstein-Barr Virus (EBV) tumour targets

• What are the main issues regarding immunotherapy for EBV-associated tumours?
• What are the current approaches to such treatment?
• What may the future hold for EBV immunotherapy?

Dr Ingólfur Johannessen, Consultant Medical Virologist & Honorary Senior Clinical Lecturer, Dept of Laboratory Medicine, The Royal Infirmary of Edinburgh (University of Edinburgh)

3.10

Panel discussion
What are the translational opportunities between AI for cancer and infectious diseases?

• What are the T cell response system similarities between cancer and chronic infectious diseases?

3.35

Chair’s closing summary

3.40

Afternoon tea in the exhibition area

4.25

Regulatory perspective
FDA / EMEA approaches to combination investigations: How well defined and harmonised are the regulatory mechanisms?

• If both agents are unapproved how do you move forward, especially when 2 different companies are involved?

Dr Thomas Hinz, Head of Section, Therapeutic Vaccines, Paul-Ehrlich-Institut
Dr Joyce Frey-Vasconcells, Executive Director, PharmaNet Consulting, PharmaNet Development Group

4.55

Panel discussion
From a business development perspective, how can we overcome the strategic development concerns with AI combination therapies?

• What are the best commercial strategies for combination?
  • What evidence is there from the cancer, infectious diseases, allergy and autoimmune fields?
• Timing issues: How to combine 2 or more products when none or only 1 is approved?
  • Who will take the risk of development and at what stage?
• Stacking royalties: To what extent can they compromise the commercial viability of an AI combination product?
• Recognising when combination approaches might have synergistic effects or completely the contrary eg with
  • General immunomodulation
  • Chemo
  • Anti-angiogenesis drugs
  • Small molecules: Should you seek or avoid them as combinations?
• Moving to earlier stage combinations: Is this the future?
  • How to be confident that you have the right approach?

Panellists:
Charles A. Nicolette, PhD, Chief Scientific Officer, Vice President, R&D, Argos Therapeutics, Inc
Dr Harpreet Singh, CSO, immatics biotechnologies GmbH
Dr Thomas A. Davis, CMO & Senior Vice President, Clinical Development, Celldex Therapeutics

5.40

End of day 2 followed by a themed cocktail reception in the exhibition area