Session: Hot Topic: Learnings From Managing Immunogenicity Risks to Protein Based Therapeutics; Need to Pivot for Cell and Gene Therapies or 1 Size Fits All?
Preclinical and Clinical Immunogenicity Risk Mitigation and Management for CAR-T Therapies
Executive Director Bristol Myers Squibb Lawrenceville, New Jersey
The preclinical development of CART based therapies may require a strategy that can leverage learnings from early process development of biologics and quality by design efforts. As drug products are cells themselves, the added risk from cell associated attributes and novel multi-domain constructs will need to be evaluated and any identified risks mitigated by re-optimization or by re-engineering as well as the clinical trial experience that can be used to improve the future products. The talk will cover the anticipated risks from cellular therapies and next generation constructs with multiple domains to capture multiple tumor targets as well as engage the T-cells to be more effective killers. Additionally, risks due to allogeneic CAR cells ( T cells), NK cells, stem cell derived engineered cells as TCR T cells will be presented.
Learning Objectives:
Understand the similarities of discovery and development efforts between the biologics and novel cellular therapies
Evaluate what can be levergaed from the risk assessment and mititgation efforts of biologics to understand risks of CART therapies
Identify the novel complexities of the cellular therapies and next generation modalities like armored CARTs, allogeneic CARTs, NK cells based CARs, TCRTs , stem cells based CARTs etc.
