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
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 Invariant NKT Cells Unleashed: Building a Pipeline for Cutting-Edge Allogeneic Cell Therapies
Synopsis
• 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
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
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
2:00 pm Unravelling the Regulatory Roadmap for Allogeneic Products
Synopsis
• 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
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
3:30 pm Focusing in on the Regulatory Landscape for Allogeneic Cell Therapies
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