Conference Day Two

Wednesday 31st January, 2024

8:00 am Coffee & Networking

Charting the Course of Allogeneic Therapies: Emerging Pipelines & Data Catalysing the Field

9:50 am Chair’s Opening Remarks

10:00 am Reporting Clinical Data from a First-in-Class Plasmacytoid Dendritic Cell Line Vaccine in Patients with Metastatic NSCLC

  • Eric Halioua President & Chief Executive Officer, PDC*line Pharma


• Understanding the characteristics and applications of the PDC*vac technology as a

novel allogeneic cancer vaccine

• Reviewing early safety, tolerability, and immunogenicity findings from this phase one trial

• Discussing initial signs of clinical activity associated with the vaccine in NSCLC patients

10:30 am Morning Refreshments & Networking

Establishing Robust & Reproducible Processes: Critical Steps for Allogeneic Bioprocess Development

11:30 am Invariant NKT Cells Unleashed: Building a Pipeline for Cutting-Edge Allogeneic Cell Therapies


• iNKT-CD19 CAR progressing from discovery towards first-in-human clinical trial against hematological malignancies.

• Combining iNKT-CD19 CAR with a CD19-expressing oncolytic virus to target solid tumors.

• Incorporation of CARs targeting solid tumors into the iNKT platform. Claudin 18.2 as a promising target against gastric and pancreatic tumors.

12:00 pm Translating Allogeneic Research to Manufacturing Without Sacrificing Efficacy & Quality


• Examining how manufacturing processes influence critical cell product attributes and

clinical efficacy

• Identifying key process parameters and control strategies to ensure product quality at


• Implementing process characterisation and comparability studies to support technical


12:30 pm Lunch Networking & Refreshments

1:30 pm Enhancing Raw Material Qualification, In-Process Monitoring, & Quality Control Testing to Minimize Batch Failures & Ensure Consistent Product Quality

  • Jan Talts Chief Operating Officer, Amniotics


• Understanding the essential parameters for selecting raw material to maximise

product quality

• Strengthening raw material standards through enhanced supplier qualification

• Developing more sensitive quality control assays and tests for allogeneic cell therapies

2:00 pm Unravelling the Regulatory Roadmap for Allogeneic Products


• Recent guideline changes in Europe to inform on clinical trial design and data requirements 

• How new cell and gene therapy comparability guidelines may impact process changes during development 

• Global differences in data requirements for the transition from preclinical to clinical trials 

Upscaling Manufacturing to Make Accessible Off-the-Shelf Therapies

3:00 pm Modulating Metabolism During Manufacturing to Improve Anti-Tumour Efficacy & Persistence of CAR-T Cell Therapies


  • Overview of MPC Therapeutics’ approach to target the mitochondrial pyruvate carrier (MPC) to reprogamme CAR-T cell metabolism
  • Discussing preclinical data showing MPC inhibition during manufacturing dramatically improves CAR-T cell survival and efficacy
  • Exploring challenges and opportunities in translating novel manufacturing processes targeting metabolism to the clinic

3:30 pm Focusing in on the Regulatory Landscape for Allogeneic Cell Therapies

  • Greg Kunst President, Chief Executive Officer & Board Member, Aurion Biotech


  • Examining acceptance criteria expectations around gene editing, toxicity, and potency assays
  • Highlighting importance of early CMC work to enable efficient manufacturing scale-up for allogeneic products
  • Evaluating opportunities to align global regulatory perspectives on allogeneic therapies

4:00 pm Chair’s Closing Remarks

4:10 pm Close of Summit