Conference Day Two

Wednesday 31st January, 2024

8:00 am Coffee & Networking

8:50 am Chair’s Opening Remarks

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

9:00 am Audience Discussion: Highlighting Innovative Preclinical & Clinical Pipelines with High Potential for Clinical Impact

Synopsis

• Discussing emerging allogeneic NK- and T-cell therapies demonstrating potent antitumour

activity

• Reviewing cutting-edge allogeneic CAR platforms designed to enhance persistence

• Looking across disease types to look for opportunities for allogeneic therapies

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

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

Synopsis

• 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 Strategising the Transition from Autologous to Allogeneic Cell Therapy Platforms

Synopsis

• Evaluating development and manufacturing considerations for converting autologous

therapies

• Discussing strategies to balance implementing allogeneic products while continuing

autologous programs

• Comparing regulatory requirements between autologous and allogeneic platforms

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

Synopsis

• Examining how manufacturing processes influence critical cell product attributes and

clinical efficacy

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

scale

• Implementing process characterisation and comparability studies to support technical

transfer

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

Synopsis

• 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

Upscaling Manufacturing to Make Accessible Off-the-Shelf Therapies

2:00 pm Streamlining Manufacturing of TCR-NK Cells to Unlock the Benefits of Dual Targeting Allogeneic Cell Therapies

  • Emilie Gauthy Head of Chemistry, Manufacturing & Controls, Zelluna Immunotherapy

Synopsis

• Overview of Zelluna’s development of TCR-NK cells combining TCR specificity with

innate NK activation

• Discussing scalable manufacturing approaches to integrate TCR and NK cell production

• Examining challenges and opportunities to translate novel TCR-NK cell platforms to

widespread clinical use

2:30 pm Modulating Metabolism During Manufacturing to Improve Anti-Tumour Efficacy & Persistence of CAR-T Cell Therapies

Synopsis

  • 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

3:00 pm Focusing in on the Regulatory Landscape for Allogeneic Cell Therapies

  • Greg Kunst President & Chief Executive Officer, Aurion Biotech

Synopsis

  • 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

3:30 pm Chair’s Closing Remarks

3:40 pm Close of Summit

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