Thursday March 21, 18:30 – 21:30. To include dinner
SC3: Managing the Challenges of Bioassays for Immuno-Oncology

Instructors:

Sofie Pattijn, CTO, ImmunXperts

Gisèle Deblandre, CSO, MaSTherCell

Short Course Description:

During the last years, significant advancement has been made in the clinical application of cancer immunotherapies.  Molecules directed against immune checkpoints and other agonists show great promise for treatment of a variety of malignancies. Early evaluation of the effectiveness of candidate therapeutics and combination therapies can be done using mouse models and in vitro bioassays with primary mouse or human immune cells.

Part One: Bioassays for Non-Cellular Products

This short course will present experiences and data regarding bioassays for immune-modulatory antibodies and combination approaches.

• It will address the challenges with:
  • Dealing with the primary cells
  • Importance of understanding the question you want answered and designing and interpreting an appropriate assay
  • Translating the results
  • Managing expectations
• It will examine:
  • Prediction versus documenting MOA
  • What the bioassay does, what it is measuring, what it means and its value.
• Technical challenges will be addressed
• Case studies with data

Part Two: Bioassays for Cellular Products

This second part of the short course will focus on bioassays used to support clinical development of cell-based immunotherapies more specifically CAR or TCR T-cell therapies. It will address the challenges linked with the choice/design of assays for toxicity and potency assessment. 

• Safety assays
  • Risk assessment with a focus on incoming material and genetic engineering steps
  • Assessment of off-target effects
  • Assessment of tumorogenicity with a focus on viral vector insertion
  • Predictivity of current in vitro tumorogenicity assays
  • Animal models for safety and toxicity
• Efficacy and potency assays
  • Recapitulating a mode of action in animal and in vitro models
  • In vitro assays for potency
  • Technical challenges
  • Case study

Meet the Instructors:

Sofie Pattijn, CTO, ImmunXperts

Sofie Pattijn (CTO and founder, ImmunXperts) has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development. She has extensive hands-on lab experience and has managed and coached several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium for over 15 years.

Gisèle Deblandre, CSO, MaSTherCell

Over the last 10 years, Gisele has worked extensively on process and analytical assay development for cell and gene therapies at all phases of their clinical development. At MaSTherCell, Gisèle has led development efforts for a series of immunotherapies. Previously with Celyad (Belgium) she headed the development of an autologous cell therapy for the treatment of heart failure and at the laboratory of Paediatric Hepatology