7:30am | Registration and Coffee

8:20 am Chair’s Opening Remarks

8:30 am Antigen-Specific Targeting of Tumours Across MHC Barriers

  • Lucia Mori Founding Chief Scientific Officer , Matterhorn Biosciences
  • Giulia Casorati Head of Experimental Immunology Unit, San Raffaele Scientific Institute

Synopsis

• Looking beyond peptide antigens in tumour therapy
• The advantages of targeting oligomorphic antigenpresenting molecules
• The advantages of adoptive cell therapies based on MR1- restricted TCRs specific for tumour-associated metabolites, and CD1c-restricted TCRs specific for a leukaemiaassociated lipid antigen

9:00 am Industry Leaders’ Fireside Chat – Setting a Trailblazing Fire to the Cell Therapy Field with Next Generation Approaches

Synopsis

An executive panel discussion from the industry leaders of the field to set the scene on next generation CAR-TCR therapies. Ask your questions live to understand the expert’s thoughts on key topics including:

  • Successes and hurdles to date: T-cell therapy translation to solid tumours, non-oncologic disorders and off-the-shelf (ex vivo and in vivo) T-cell engineering
  • Innovative construct design that has the potential to enhance the targeting of CAR cells
  • Exploring novel multi-targeting technology alongside the use of accessory proteins to enhance potency and engagement

9:30 am Hypoimmune & In Vivo Delivery Platforms to Enable Off-The-Shelf CAR-T Cell Therapies

  • Terry Fry Senior Vice President, Head of T Cell Therapeutics, Sana Biotechnology, Inc.Institute

Synopsis

  • The complexities in manufacturing autologous products limits access to highly effective CAR-T cell therapy
  • Allogeneic T-cells manufactured using Sana’s hypoimmune technology evade both innate and adaptive immunity
  • Sana’s gene delivery platform efficiently generates a functional CAR-T cell in vivo

10:00am | Morning Refreshments & Structured Networking

Novel
Platforms

Exploring Novel CAR-TCR Platforms to Supercharge Next Generation Cell Therapy

11:00 am A Next Generation TCR & Epitope Discovery Platform for the Development of Engineered TCR Therapies for Solid Tumours

Synopsis

  • HuTCR, an innovative platform based on complex genetic engineering, leverages natural immune processes to generate TCRs with optimal affinity and high specificity
  • Parallel epitope discovery and TCR identification to enhance throughput and reduce discovery lead time
  • TK-8001, a CD8 TCR-T specific for a MAGE-A1 epitope presented on HLA-A*02-01

11:30 am Tumour-Effector Cell Avidity is a Key Driver for Cellular Therapy Efficacy

  • Peter Djali Manager, Cell Avidity/Immuno-Oncology Division, LUMICKS

Synopsis

  • Avidity is a new key parameter for predicting T-cell function
  • Avidity data strongly correlates to in vitro functional assays and preclinical mouse studies
  • The z-Movi Cell Avidity Analyzer measures the avidity of lymphocytes with tumour cells at the single-cell level using an extremely quick and easy workflow

12:00 pm CAR-T Cell Immunotherapy of Solid Tumours: Parallel Learning from the Clinic & Lab

  • John Maher Chief Scientific Officer , Leucid Bio

Synopsis

  • Summary of a dise escalation phase 1 clinical trial of panErbB CAR-T cells patients with head and neck cancer
  • Summary of a novel CAR platform dubbed a parallel (p)CAR, which consists of a CD28-containing second generation CAR and a 4-1BB containing chimeric costimulatory receptor
  • pCAR engineered T-cells demonstrate superior restimulation potential in vitro, and exert superior efficacy in 2D and 3D tumour/stroma model systems
  • Superior in vivo activity has been demonstrated in a range of cell line- and patient derived-tumour xenograft models, when compared to traditional linear CAR designs

Advanced Clinical Developments

Enhancing Trafficking of CAR-T Cells to Overcome the Hostile Tumour Microenvironment

11:00 am Driving Clinical Activity of TCR-T Cells in the Challenging Solid Tumour Setting

Synopsis

  • Developing TCR-engineered T-cells against PRAMEpositive solid tumours
  • Leveraging the power of TCR-T cells: safety and antitumour activity of TCR-T cells directed against PRAMEpositive solid tumours
  • Potentiating anti-tumour activity through CD8αβ cotransduction
  • Tackling the tumour microenvironment by next generation TCR-T cells directed against a novel tumour stroma target

11:30 am Next-Generation DNA NanoVectors – An Alternative Vector Platform for the Safe, Rapid, and Persistent Manufacture of Recombinant T cells for Autologous T Cell Immunotherapy

Synopsis

  • A novel non-integrating minimally sized DNA vector platform named nS/MARt was used to efficiently engineer human T lymphocytes
  • When nS/MARt technology was combined with GMPcompliant MaxCyte Flow Electroporation®, the production of clinical scale recombinant CAR T cells with enhanced antitumor activity was achieved in only five days
  • The key advantages of the nS/MARt vector platform include simplified vector engineering, low immunogenicity, and low production costs enabling rapid manufacture of safe and effective CAR T cell therapies for thousands of patients

12:00 pm Track Closed

Synopsis

 

 

 

 

 

Manufacturing
Innovations

Revolutionising the Production of Large-Scale Cell Therapy Through Automation & Innovation

11:00 am Paving the Future of Supply Chain & Logistics with Digitalisation & Automation

Synopsis

  • Exploring how to digitalise the chain of custody and chain of identity for efficient patient and product tracking
  • Demonstrating that the automated system shows the same consistency as manual processes

11:30 am Akron’s New Line of Closed System Solutions™ & the Production of Next Generation Cell-Based Immunotherapies

Synopsis

• The industrialization of cell therapy manufacturing will require a transition to closed system production, with the direct integration of critical ancillary materials
• First to market with a liquid cytokines, Akron now introduces its IL-2 in single-use bags with weldable
tubing, offering minimum activity levels appropriate for manufacturing at any scale
• Akron’s Human AB Serum (converted from Octaplas®) and HSA 25% Closed System Solutions allow for the seamless integration of critical media supplements without compromising sterility

 

 

 

 

 

 

12:00 pm Autologous CAR-T Cell Automation and Certification Time

12:30 pm Lunchtime Refreshments

Optimising In Vivo Approaches for Enhanced Target Cell Specificity

1:30 pm A Nanotechnology-Based In Vivo Gene Delivery Platform Allowing the In Vivo Targeting & Transduction of T-Cells for Haematological Malignancies & Beyond

Synopsis

  • Presentation of the gene delivery platform
  • In vitro and in vivo safety and efficacy data
  • Towards clinics

2:00 pm 3 Key Factors in Cell Cryopreservation that Impact the Manufacturability of Cell & Gene Therapies

  • Robert Newman Chief Scientific Officer, FUJIFILM Irvine Scientific

Synopsis

• The principles of cryopreservation as learned from immune cells, stem cells, and embryos
• Developing cryopreservation reagents and protocols for cell & gene therapy manufacturability
• Criticality of source materials on the quality of the final product

2:30 pm Attacking Solid Tumours with an Integrated Approach of Universal Tumour Tags & In Vivo Transduced CARs

  • David Fontana Chief Business & Strategy Officer, Umoja BioPharma

Synopsis

  • Cell therapy progress in hematological tumours is transformational however solid tumours still a remain a challenge
  • Novel targeting both tumour cells and local stromal cells will be discussed
  • Tumour tagging along with in vivo CAR transduction offers a unique solution to known issues current approaches

3:00 pm Panel Discussion: Changing the Face of Cell Therapies with In Vivo Gene Engineering

  • David Fontana Chief Business & Strategy Officer, Umoja BioPharma
  • Cécile Bauche Chief Scientific Officer, Ixaka
  • John Rossi Senior Vice President, Translational Medicines & Research, CERo Therapeutics

Synopsis

  • Exploring the potential to develop a universal cell therapy without ex vivo isolation/expansion of T-cells
  • How can we improve safety, dosing and efficacy by using mRNA to create CAR-T cells in vivo?
  • Discussing how to control the pharmacokinetic properties of the cell product

Engineering Novel
CAR Constructs
to Reduce On-Target
Off-Tumour Toxicity & Assessing Persistence

1:30 pm Overcoming CAR-T Toxicity with Next Generation T-Cell Reprogramming

Synopsis

  • Highly potent and armoured CAR-T cells are necessary of inducing responses in solid tumours. This increases the risk of on-target off-tumour toxicity as well as severe immunotoxicity
  • Additionally, the unique solid tumour microenvironment can amplify cytokine release syndrome
  • We have engineered a next generation armoured CAR-T that has the potential to have lower risk of on-target off-tumour toxicity and severe immunotoxicity but with enhanced potential for efficacy

2:00 pm How to Overcome the Recruitment Challenges in CAR-T cell Clinical Trials

Synopsis

• Building the strategy ahead of Clinical Trial: key challenges the company-developer of the new therapy faces in patients’ recruitment for CAR-T Cell clinical trials
• How to solve the under recruitment by applying a new way of scientific collaboration and support with investigators
• How to build the trustworthy relationship with investigators (key lessons learned) as a key for a steady enrolment into the study

2:30 pm Next Generation Allogeneic CAR-T Cell Therapies for Hematologic Malignancies

Synopsis

• Next-generation genome editing platform to develop allogeneic CAR-T cell therapies
• Implementation of armouring strategies to promote CAR-T cell persistence

3:00 pm Next-Gen Cell Therapies- Listening and Engaging with Patient Perspectives as an Essential Element in Clinical Trials

  • Jane Bentley VP, Project Management, Syneos Health
  • Lynn Donald Senior Project Director, Syneos Health , Novel and Emerging Therapies, Oncology
  • Sophie Papa Chief Medical Officer, Enara Bio
  • Rayna Patel Co-Founder & CEO , Vinehealth

Navigating Through Manufacturing Challenges to Supercharge Off-the-Shelf Therapies

1:30 pm Process Intensification and Scalable Manufacturing Strategies for CAR-T Production

  • Qasim Rafiq Senior Lecturer & Associate Professor - Cell & Gene Therapy Bioprocessing, University College London

Synopsis

  • Demonstrating the consistent and scalable expansion of CAR-T cells from multiple donors in stirred-tank bioreactors
  • Approaches to reduce the variability and scalability issues of advanced therapies
  • Establishment of a control strategy for CAR-T process intensification

2:00 pm Flexible & Innovative Design Considerations for Cell Therapy Processes & Facilities

  • Joe Codamo Senior Director, Catalent Pharma Solutions

Synopsis

  • The number of autologous cell therapy products commercially approved or approaching launch is growing, with allogenic therapies very close behind
  • CDMOs need to ensure they are designing innovative processes and flexible facilities that can accommodate both autologous and allogenic cell therapy products for small and large patient populations
  • We explore the considerations that need to be taken during development to ensure manufacturing processes and our facilities can support the high throughput needed to supply expanding patient populations once products go commercial

2:30 pm Building on Non-Gene Edited Approaches to Develop Allogeneic, Off-The-Shelf CAR-T Cells

Synopsis

  • Development of alternative non-gene edited approaches, from research to clinical trials
  • Advantages of relying on a single viral transduction: safety and manufacturing perspectives

3:00 pm Panel Discussion: Creating the Therapies of Tomorrow with Large Scale Production of Off-the-Shelf Products

Synopsis

  • Exploring how to scale up allogeneic CAR-T cell products to treat a larger patient population
  • Expanding allogeneic T-cells without compromising in vivo function
  • Discussing how to enhance characterisation of allogeneic CAR-T products

3:30 pm Tech Slam & Afternoon Break

Advancing Discovery & Development of Novel Targets to Achieve Success in Solid Tumours

4:30 pm Integrated Target Discovery & TCR Generation Pipelines for TCR-Modified Cell Therapies

Synopsis

• Addressing the rich target space for TCR-modified cell therapies
• Integrating unbiased target discovery with TCR generation
• Considerations for TCR characterisation and safety profiling

5:00 pm Reprogramming T Cell Fate and Antitumor Function by MicroRNA Therapeutics

  • Luca Gattinoni Professor, Chair for Functional Immune Cell Modulation, Leibniz Institute for Immunotherapy

Synopsis

• Overexpression of miR-155 enhances homeostatic cytokine signaling overcoming the need of lymphodepletion preconditioning.
• miR-155 modulates T cell epigenetic circuitry to restrict terminal differentiation and functional exhaustion.
• A human miR-155 SNP boost CAR T cell polyfunctionality and antitumor responses more effectively than its wild-type counterpart

5:30 pm Identification & Testing of Novel Cancer-Restricted Targets & Their TCRS to Develop Safe & Effective T-Cell Treatment

Synopsis

To fully exploit the therapeutic potential of TCR-T cells, we use our platform to:

  • Limit toxicity attributed to recognition of identical or highly similar targets outside cancers
  • Deliver shared intracellular targets that are cancer-selective to treat large cohorts of patients
  • Counteract the immune-suppressive nature of tumour microenvironments

6:00 pm Identifying Peptide Targets for TCR-Ts Derived from Non-Coding RNA Sequences

Synopsis

  • Understanding the relevance of dark matter antigens identified in tumour cells that are determined by noncoding RNA sequences
  • Using novel organoid cancer cell models to understand T-cell responses to dark matter- derived peptides
  • Devising tools to understand the relevance of dark matter peptides as targets for TCR-T-based immunotherapy of solid cancer

Highlighting Safety
& Feasibility
of Allogeneic
Cell Therapies

4:30 pm Roundtable Discussion: Exploring Safety, Function and Potency of Allogeneic CAR-T Cells

5:00 pm Navigating the Challenges and Safety Considerations for Next-Generation Cell Therapies

  • Houria Bachtarzi Associate Director, Regulatory - Gene and Cell Therapies, ProPharma Group

Synopsis

  • Cell Therapies in the era of next-generation technologies
  • Manufacturing/Quality-related safety considerations
  • ATMP development – moving towards a global harmonised regulatory framework

5:30 pm Accelerating Clinical Development of Off-the-Shelf Cell Therapy for Liquid and Solid Tumours

  • Jakob Dupont Executive Vice President, Head of Global Research & Development, Atara Biotherapeutics

Synopsis

  • Clinical and regulatory experience with Atara’s Phase 2 and Phase 3 allogeneic T-cell therapies
  • Benefits of allogeneic approach and scaling manufacturing to meet patient needs
  • How armouring next generation allogeneic T-cell immunotherapies can overcome the hostile tumour environment

6:00 pm Driving Development of Allogeneic Cell Therapies and CAR-T with Novel Signalling Technologies

Synopsis

  • Leveraging naturally occurring multifunctional T-cell populations that harness innate and adaptive cell function
  • Developing non-gene edited allogeneic CAR-T therapies on a novel gamma-delta platform
  • Evolving platform capabilities using novel technologies for enhancement

Advancing Gene Engineering Strategies for Cell Therapies

4:30 pm Bioproduction Challenges to Bring In Vivo Car-T into the Clinic

Synopsis

  • How to manufacture vectors used for in vivo gene delivery
  • How to adapt the bio-manufacturing and the corresponding QC to fulfil the regulatory agencies expectations and move towards industrialisation

 

 

 

 

 

 

5:00 pm Advances in Non-Viral T-Cell Engineering in Clinical Manufacturing

  • Toni Cathomen Professor of Cell and Gene Therapy, Director, Institute for Transfusion Medicine and Gene Therapy,Scientific Director, Center for Chronic Immunodeficiency, University of Freiburg

Synopsis

  • Combining CAR T cells with genome editing
  • Automated manufacturing of gene-edited CAR T cells
  • Evaluation of genotoxicy by CAST-Seq

5:30 pm Improving T-Cell Function with Epigenetic & Genetic Reprogramming to Improve Cell Therapy Outcomes in Solid Tumours

  • Tina Albertson Chief Medical Officer, Head of Development , Lyell Immunopharma

Synopsis

• Epigenetic reprogramming (Epi-R) results in durable stemness of T-cells
• Genetic reprogramming (Gen-R) limits T-cell exhaustion after infusion to reverse the suppressive effects of the tumour microenvironment and continuous antigen stimulation
• These technologies are being evaluated in all T-cell modalities, CAR-T cells (CAR), TCR engineered T-cells (TCR), and tumour infiltrating lymphocytes (TIL) products

6:00 pm Roundtable Discussion- Manufacturing Innovations to Improve Robustness of T cell Therapies

Synopsis

  • Measures to increase success rates and manufacturing yields of genetically modified T cells
  • Reviewing current and future strategies to manufacture autologous products, reduce variability, increase success rates and reduce cost and turn-around times

6:30 pm Chair’s Closing Remarks

6:45 pm Drinks Reception