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27th February 2017

Focus Day

8:30 am Registration and Coffee

Solid Tumour Track

Chair- David Gilham, VP, Research & Development, Celyad

Clinical Management

Chair- Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Cell Trafficking and Tumour Penetration

Managing Adverse Events

9.00 ACTallo®: Off-the-Shelf, TCR Engineered Vγ9δ2 T Cells for the Treatment of Solid Cancer
• Vγ9δ2 T cells have a natural ability to infiltrate solid cancer, independent of the presence of αβ T cells
• When present in patients’ cancer, Vγ9δ2 T cells correlate with positive prognosis
• With ACTallo®, we intend to leverage Vγ9δ2 T cells to develop a novel generation of TCRengineered allogeneic cell therapies, with features distinctive from other off-the-shelf modalities
Yannick Bulliard, Director, Translational Development, Immatics

9.00 Enhance Success Rates of Patients with MRD
• Strategies to measure and identify high risk patients
• Review methods of converting MRD positive patients into MRD negative to increase the
chances of successful therapy

9.30 Overcoming CAR-T Cell Metabolic Antagonism in the TME
• Describe the metabolic states during the life of an antitumor T cell
• Examine the metabolism of the CAR-T cell at the tumour site to understand how the microenvironment could impact their function
• Assess engineering strategies to help expand cells in these detrimental environments
• Basic analysis of protein expression, gene expression and cell interaction in the TME
Alessandra Cesano, At-large Director, SITC; Co-chair of Adoptive Cell Therapy Working Group

9.30 Toxicity Management
• Review predictive biomarkers to identify early signs of toxicity.
• Discuss the training needed by clinical trial staff to manage patient toxicity
• Standardise algorithms to manage toxicity
Agnes Schubert, Global Program Safety Lead, Novartis

Solid Tumour Track

Chair - David Gilham, VP, Research & Development, Celyad

Cell Trafficking and Tumour Penetration

9.00 ACTallo®: Off-the-Shelf, TCR Engineered Vγ9δ2 T Cells for the Treatment of Solid Cancer
• Vγ9δ2 T cells have a natural ability to infiltrate solid cancer, independent of the presence of αβ T cells
• When present in patients’ cancer, Vγ9δ2 T cells correlate with positive prognosis
• With ACTallo®, we intend to leverage Vγ9δ2 T cells to develop a novel generation of TCRengineered allogeneic cell therapies, with features distinctive from other off-the-shelf modalities
Yannick Bulliard, Director, Translational Development, Immatics


9.30 Overcoming CAR-T Cell Metabolic Antagonism in the TME
• Describe the metabolic states during the life of an antitumor T cell
• Examine the metabolism of the CAR-T cell at the tumour site to understand how the microenvironment could impact their function
• Assess engineering strategies to help expand cells in these detrimental environments
• Basic analysis of protein expression, gene expression and cell interaction in the TME
Alessandra Cesano, At-large Director, SITC; Co-chair of Adoptive Cell Therapy Working Group

Clinical Management

Chair - Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Managing Adverse Effects

9.00 Enhance Success Rates of Patients with MRD
• Strategies to measure and identify high risk patients
• Review methods of converting MRD positive patients into MRD negative to increase the
chances of successful therapy


9.30 Toxicity Management
• Review predictive biomarkers to identify early signs of toxicity.
• Discuss the training needed by clinical trial staff to manage patient toxicity
• Standardise algorithms to manage toxicity
Agnes Schubert, Global Program Safety Lead, Novartis

10:00 am Morning Refreshments & Networking

Solid Tumour Track

Chair- David Gilham, VP, Research & Development, Celyad

Clinical Management

Chair- Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Driving Potency in Suppressive Environments

Preparing Institutional Readiness in Europe

11.30 Solid Tumour Immunotherapy Using Parallel CAR T Cells
• Analyse the rationale for parallel CAR configuration
• Share experience of pCAR immunotherapy of haematological tumours compared to experience of pCAR immunotherapy for solid tumours
John Maher, Immunology Consultant, King’s College London / CSO, Leucid Bio

11.30 Considerations for Recruitment and Preparation of Clinical Sites Participating in a TCR-T Study
• Explore what kind of training must be carried out to ensure the setting is registration ready
• Understand which Standard Operating Procedures must be in place before dosing begins
• Experience on scheduling training plans to ensure a successful CAR-T trial
Jens-Peter Marschner, CMO, Zelluna Immunotherapy

12.00 Use of Innovative Tools can Improve Safety and Efficacy of TCR-T
Immunotherapies
• Next generations of TCR-Ts are envisioned to move beyond use of simple TCRs in simple recipient T cells
• An option to regulate TCR expression opens the possibility to turn TCR-T activity “on and off” for enhanced control of safety
• TCR-Ts can be modified with switch receptors to enhance their functional activities in hostile interactions with tumour cells
Dolores Schendel, CEO & CSO, Medigene

12.00 Clinical Perspective of Operational Management
• Operational considerations for global CAR-TCR trials
• Key considerations from enrolment to infusion
• Outline success factors for clinical success
Valeria Judkowski, Senior Director, QA Site Qualification EU, Kite Pharma

Solid Tumour Track

Chair - David Gilham, VP, Research & Development, Celyad

Driving Potency in Suppressive Environments

11.30 Solid Tumour Immunotherapy Using Parallel CAR T Cells
• Analyse the rationale for parallel CAR configuration
• Share experience of pCAR immunotherapy of haematological tumours compared to experience of pCAR immunotherapy for solid tumours
John Maher, Immunology Consultant, King’s College London / CSO, Leucid Bio


12.00 Use of Innovative Tools can Improve Safety and Efficacy of TCR-T
Immunotherapies
• Next generations of TCR-Ts are envisioned to move beyond use of simple TCRs in simple recipient T cells
• An option to regulate TCR expression opens the possibility to turn TCR-T activity “on and off” for enhanced control of safety
• TCR-Ts can be modified with switch receptors to enhance their functional activities in hostile interactions with tumour cells
Dolores Schendel, CEO & CSO, Medigene

Clinical Management

Chair - Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Preparing Institutional Readiness in Europe

11.30 Considerations for Recruitment and Preparation of Clinical Sites Participating in a TCR-T Study
• Explore what kind of training must be carried out to ensure the setting is registration ready
• Understand which Standard Operating Procedures must be in place before dosing begins
• Experience on scheduling training plans to ensure a successful CAR-T trial
Jens-Peter Marschner, CMO, Zelluna Immunotherapy


12.00 Clinical Perspective of Operational Management
• Operational considerations for global CAR-TCR trials
• Key considerations from enrolment to infusion
• Outline success factors for clinical success
Valeria Judkowski, Senior Director, QA Site Qualification EU, Kite Pharma

12:30 pm Lunch and Networking

Solid Tumour Track

Chair- David Gilham, VP, Research & Development, Celyad

Clinical Management

Chair- Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Advancing Tumour Recognition

Patient Management

13.30 T Cells Genetically Modified with Sleeping Beauty System to Express TCRs Targeting Neoantigens
• T cells under IND can be genetically modified using the non-viral Sleeping Beauty system to express T-cell receptors (TCRs) to redirect specificity for solid tumours
• Autologous (patient-derived) TCRs and allogeneic (3rd person-derived) TCRs can be
identified that recognise personalised neoantigens or shared neoantigens (in hotspots), respectively
• The Sleeping Beauty system scales to overcome inter-and intra-patient heterogeneity of neoantigens by expression of autologous and allogeneic TCRs in patient-derived T cells
Laurence Cooper, CEO, Ziopharm Oncology

13.30 Round Table Discussion: Scheduling a Patient Specific Therapy
• Share experience on how to manage a schedule when a patient falls sick and autologous products are unstable to delay delivery
• Optimise staff scheduling including data managers and clinicians to ensure support is available
• Highlight tools and best practice used to educate patients and caregivers on the therapy
• Outline the important risks that should be understood and how to support the family throughout the process

14.00 TCR Adoptive Cell Therapy: Relevance of MHC Class II and Target Selection
• Prevent on-target-off-tumour toxicity by reviewing target validation platforms to screen for
clean, tumour-specific targets
• Identify which targets have the best clinical success
Namir Hassan, CSO, Zelluna Therapy

14.00 Round Table Discussion: Scheduling a Patient Specific Therapy - CONTINUED...

Solid Tumour Track

Chair - David Gilham, VP, Research & Development, Celyad

Advancing Tumour Recognition

13.30 T Cells Genetically Modified with Sleeping Beauty System to Express TCRs Targeting Neoantigens
• T cells under IND can be genetically modified using the non-viral Sleeping Beauty system to express T-cell receptors (TCRs) to redirect specificity for solid tumours
• Autologous (patient-derived) TCRs and allogeneic (3rd person-derived) TCRs can be
identified that recognise personalised neoantigens or shared neoantigens (in hotspots), respectively
• The Sleeping Beauty system scales to overcome inter-and intra-patient heterogeneity of neoantigens by expression of autologous and allogeneic TCRs in patient-derived T cells
Laurence Cooper, CEO, Ziopharm Oncology


14.00 TCR Adoptive Cell Therapy: Relevance of MHC Class II and Target Selection
• Prevent on-target-off-tumour toxicity by reviewing target validation platforms to screen for
clean, tumour-specific targets
• Identify which targets have the best clinical success
Namir Hassan, CSO, Zelluna Therapy

Clinical Management

Chair - Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Patient Management

13.30 Round Table Discussion: Scheduling a Patient Specific Therapy
• Share experience on how to manage a schedule when a patient falls sick and autologous products are unstable to delay delivery
• Optimise staff scheduling including data managers and clinicians to ensure support is available
• Highlight tools and best practice used to educate patients and caregivers on the therapy
• Outline the important risks that should be understood and how to support the family throughout the process


14.00 Round Table Discussion: Scheduling a Patient Specific Therapy - CONTINUED...

2:30 pm End of Focus Day and Close of Summit