27th February 2020

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

Preparing Institutional Readiness in Europe

9.00 ACTallo®: Off-the-Shelf, TCR Engineered Vγ9δ2 T Cells for the Treatment of Solid Cancer

Yannick Bulliard, Director, Translational Development, Immatics

Click here to see the Event Guide for more information

9.00 Enroll to Infusion- Supporting Patient Treatments

Peter Olagunju, VP, Global Patient Operations, Bluebird Bio

Click here to see the Event Guide for more information

9.30 Overcoming CAR-T Cell Metabolic Antagonism in the TME

Alessandra Cesano, At-large Director, SITC; Co-chair of Adoptive Cell Therapy Working Group

Click here to see the Event Guide for more information

9.30 Toxicity Management

Agnes Schubert, Global Program Safety Lead, Novartis

Click here to see the Event Guide for more information

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

John Maher, Immunology Consultant, King’s College London / CSO, Leucid Bio

Click here to see the Event Guide for more information

11.30 Considerations for Recruitment and Preparation of Clinical Sites Participating in a TCR-T Study

Jens-Peter Marschner, CMO, Zelluna Immunotherapy

Click here to see the Event Guide for more information

12.00 Use of Innovative Tools can Improve Safety and Efficacy of TCR-T Immunotherapies

Dolores Schendel, CEO & CSO, Medigene

Click here to see the Event Guide for more information

12.00 Clinical Perspective of Operational Management

Valeria Judkowski, Senior Director, QA Site Qualification EU, Kite Pharma

Click here to see the Event Guide for more information

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

Laurence Cooper, CEO, Ziopharm Oncology

Click here to see the Event Guide for more information

13.30 Scheduling a Patient Specific Therapy

Jo Tomlins, Clinical Services Manager/ Nurse Clinician, The Christie NHS Foundation Trust

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14.00 TCR Adoptive Cell Therapy: Relevance of MHC Class II and Target Selection

Namir Hassan, CSO, Zelluna Therapy

Click here to see the Event Guide for more information

14.00 Patient and Product Characteristics and Correlations to Clinical Outcomes

comes and the correlations will be presented
Oezlem Anak, VP & Senior Global Head of Clinical Program, Novartis

Click here to see the Event Guide for more information

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