February 2019
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Day One
Wednesday 21st February, 2018

Day Two
Thursday 22nd February, 2018

08.00
Breakfast & Registration

08.45
Chairman’s Opening Remarks

Innovative Approaches to CAR-T & TCR in Solid Tumor Indications

09.00
T4 immunotherapy: Phase I Trial of Intra-Tumoural CAR-T Cell Therapy in Head and Neck Cancer

Synopsis

  • Phase I clinical trial of pan-ErbB targeted CAR T-cells
  • Intra-tumoural delivery to maximise therapeutic index
  • Robust manufacture using a blood draw rather than leukapheresis and selective IL-4 based cell expansion system
  • Dose escalation to 1 billion CAR T-cells
  • Update on safety and efficacy to date

09.30
How to Generate Optimal-Affinity TCRs for the Clinic?

Synopsis

  • Novel TCR targets
  • A TCR isolation platform from TCR humanized mice
  • Preclinical analysis panel for TCRs

10.00
New Frontier CAR-T and TCR technologies for Therapeutic Development

Synopsis

  • Enhanced gene editing of cells
  • Creating universal CAR T cells
  • Novel gene editing technologies and beyond
  • Dual targeting CARs
  • Bispecific engagers to improve CAR target availability
  • New technologies to insert and modify genes

10.30
Morning Refreshments & Speed Networking

Expanding the Uses of CAR-T & TCR Therapies for Enhanced Efficacy

11.30
Formulation of Gamma-Delta CAR-T Products: A Novel Approach for Solid Tumours

Synopsis

  • Utilizing different cell vehicles and approaches for CAR delivery
  • Use of other types of cells for CARs

12.00
Transitioning CAR-T success to TCR-T success

Synopsis

  • How we can apply lessons learned from CAR-T target antigens to selection of TCR target antigens
  • How we can apply lessons learned from CAR-T products to TCR-T cell product development
  • How clinical studies of CAR-T cell therapies can inform TCR-T study design

12.30
RNAscope® Platform: Enabling Preclinical and Clinical T Cell Therapy PK/PD Analysis, Target Engagement and Biomarker Analysis

Synopsis

  • The most sensitive and specific method for tissue-based target safety assessment
  • A universal method for virally-transduced T cell biodistribution analysis
  • Simple multiplexed analysis of CAR/TCR-T cells, TILs, CTL activity and targets
  • Integrated biomarker development, clinical validation and CDx

13.00
Expanding Off-the-Shelf T-Cell Therapy Applications in Cancer, Autoimmune Diseases and Serious Viral Infections

Synopsis

  • The first pivotal studies of an off-the-shelf T-cell immunotherapy in oncology for the treatment of Epstein-Barr virus (EBV)-associated lymphoma
  • The first study in patients with progressive or relapsing-remitting multiple sclerosis (MS)
  • We will discuss the potential advantages over autologous approaches including sourcing from healthy individuals, no lymphodepletion and improved safety profiles
  • Creating T-cell lines that are precisely-directed against specific targets, including Epstein-Barr virus (EBV) and CMV
  • Atara’s off-the-shelf, T-cells are HLA-matched to patients through a pre-manufactured library of cell lines

13.30
Lunch & Networking

Designing and Running Clinical Trials Effectively

14.30
Kymriah: Sharing Clinical Expertise and Experiences from the First Approved CAR-T Product

  • Oezlem Anak Senior Global Clinical Programme Head, Cell & Gene Therapies, Novartis

Synopsis

  • Comparative data of different CARs that are in the market
  • Understanding how to build and design clinical programs for cell immunotherapies
  • Experience from running development trials globally
  • What are the endpoints that matter for cell therapy clinical trial design?
  • Site selection, risk mitigation and long term follow up for patients

15.00
Running Multi Solid Tumor Trials Effectively

  • Tom Holdich Head, Global Medical Affairs & EU Clinical Development, Adaptimmune

Synopsis

  • How to run a clinical program with the same therapy across multiple indications
  • What are the different standards of care
  • How do you deliver the same product to different indications
  • Effective delivery of autologous cell products to multiple solid tumors

15.30
Early-Stage Innovations for Long-Term Success

  • Heidi Hagen Chief Strategy Officer & Co-founder , Vineti

Synopsis

  • Here’s a common early-stage challenge we’ve all faced — how to do a lot with relatively little
  • Now, growing body of best practices can help you set up your clinical phase for longterm success, through discovery to commercialization and beyond.
  • It’s now possible to start a small trial and scale it, without adding costs or staff at a commensurate rate
  • Digital systems are now simpler and more cost-effective than ever before, helping you say “Good-bye” to your clipboard and spreadsheets
  • These systems grow with you, from discovery to commercial and ongoing patient engagement, without disruption or staring over
  • The end result: Faster discovery, reduced costs, simpler compliance, faster filing

16.00
Poster Session & Refreshments

Controlling Toxicities to Overcome Safety Issues

16.30
Overcoming Mechanisms of Toxicity and Resistance

  • Jens Hasskarl Senior Director, Medical, Clinical Research & Development, Celgene

Synopsis

  • Controlling toxicities
  • Modalities to decrease toxicity
  • Identifying toxicity issues early
  • Strategies to lower and improve the safety of CAR-TCR therapies
  • Understanding CRS
  • Correlative studies linking product attributes with safety and efficacy
  • Relevance of cytokine storm to solid tumor efficacy

17.00
Approaches for understanding and derisking normal tissue target expression for chimeric antigen receptor (CAR) T cell therapies

Synopsis

  • A thorough evaluation of target expression profiles and relevant species are critical for understanding potential CAR T therapy safety risks
  • Molecular and cellular derisking approaches are an important part of the preclinical safety assessment tool box for CAR T therapies
  • Mouse models with relevant target expression patterns may serve as valuable decision-making tools for CAR T targets
  • This presentation will outline bluebird’s approach towards derisking normal tissue expression for CAR T cells, and show a case study demonstrating the utility of this approach

17.30
Panel: Mitigating Safety Risks of CAR-TCR Therapies: Ensuring Durability, Expansion and Persistence

  • Jens Hasskarl Senior Director, Medical, Clinical Research & Development, Celgene
  • Laurent Poirot Head of Early Discovery, Cellectis
  • Simon Lacey Director, Translational & Correlative Studies Laboratory, University of Pennsylvania

Synopsis

  • Controlling cells in vivo
  • Utilizing switch mechanisms
  • Regulated activation of T-cells
  • On and off switches
  • Modulating CAR-TCR activity
  • Effects of in vivo expansion and persistence
  • Effect of different media formulations on CAR-T durability
  • Tracking and imaging cells in vivo to identify persistence
  • Methods to improve in vivo expansion

18.00
Chairman’s Closing Remarks & Close of Day 1