Immunogenicity and biodistribution of CAR T therapy
In this webinar, we describe the development and validation of a functionally relevant, sensitive and reproducible cell-based assay for the qualitative determination of potentially neutralizing antibodies to CAR19.
Chimeric antigen receptor T-cell (CAR T) therapies have transformed the treatment of advanced relapsed or refractory (r/r) B-cell malignancies with patients continuing to remain cancer free beyond a decade after receiving their first infusion. Clinical trials supporting registration of CAR T therapies have exclusively examined total humoral and cellular immunogenicity, results of which do not correlate with observed clinical outcomes like efficacy and safety or cellular kinetics of CAR T cells. There is need from regulators and drug developers to utilize functional (e.g., cell-based) reporter assays to detect potentially neutralizing anti-CAR antibodies to establish the relationship more conclusively between observed immunogenicity and clinical responses for the next generation of CAR T therapies. In this webinar, we describe the development and validation of a functionally relevant, sensitive and reproducible cell-based assay for the qualitative determination of potentially neutralizing antibodies to CAR19.
- Immunogenicity to CAR T therapies are poorly understood
- Standardizing the analytical methods addressing immunogenicity to CAR T therapies may be the first step to understanding it.
- Pre-existing or treatment induced Abs may be associated with treatment failure in some cases
- Drug developers of CAR T therapies
- Bioanalytical scientists
- Academics
Speakers
Jennifer Bordeaux
Associate Director, Digital Pathology
Navigate BioPharma Services, Inc. (CA, USA)
Jennifer Bordeaux, PhD, is the Associate Director of Digital Pathology Solutions at Navigate Biopharma Services, Inc., a Novartis subsidiary. Dr Bordeaux received her PhD from Yale University (CT, USA) under the supervision of David Rimm, MD, PhD. With over 10 years’ industry experience in digital pathology techniques, she leads a team of scientists developing highly complex custom multiplexed fluorescence ISH and immunohistochemistry assays to support biomarker testing for clinical trial applications.
David Escobar
Associate Director, Ligand Binding Assay Technologies
Navigate BioPharma Services, Inc. (CA, USA)
Originally from La Paz, Bolivia, David emigrated to the US in 1988. He received his BS in molecular biology from San Diego State University (CA, USA) in 1998. He has been fortunate to interact and learn from talented scientists from all walks of life. He incurred into the bioanalytical world in 2006 working as an operator in Joe Smolec’s laboratory testing for PK and immunogenicity evaluations. Eleven years and countless validations later, in 2017, he joined Navigate BioPharma Services, where he is currently the manager for the ligand binding group.
In association with
This webinar was recorded on Thursday the 26th of October 2023