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A roadmap to earlier efficacy predictors and drivers in cell therapy development

CAR T therapy has revolutionized the treatment of hematologic cancers. However, only six drugs have been approved by the U.S. Food & Drug Administration (FDA) since 2017. With the cost and time pressures many drug developers are facing, having the right data to make decisions regarding advancing or terminating asset development is critical at every phase. Combining a validated minimal residual disease (MRD) assay with next-generation T-cell receptor (TCR) sequencing can yield powerful insights throughout the drug development process, including:

Understanding efficacy by tracking disease burden
Providing quantitative product characterization and sensitive in vivo tracking of infused T cells across multiple tissue types and time points to understand pharmacokinetics and pharmacodynamics
Determining which T cells expand and contract to provide insight on safety

Participants can expect to learn more about: 1) how using a validated MRD assay in clinical trials can help researchers understand subjects’ responses to a CAR T asset and 2) how TCR sequencing can illuminate what is happening in the repertoire to elicit this response.

Additionally, gaining timely FDA approval of assets that are performing can speed time to market and move from investment spending to revenue generation. Following the FDA’s most recent guidance regarding cell therapy validation, tracking and monitoring of engineered T cells will be discussed.

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Trace Henry

Associate Director, Medical Affairs, Adaptive Biotechnologies

Trace Henry, PhD, leads Adaptive’s biopharma efforts to build scientific collaborations with industry partners using next generation sequencing (NGS) assays to advance novel drug assets. Prior to Adaptive, Trace was the Eastern seaboard medical science liaison for Innate Pharma’s Lumoxiti, an anti-CD22 immunotoxin indicated for the treatment of relapsed/refractory hairy cell leukemia. He completed postdoc work at the HHMI Janelia Research Campus, where he applied high-dimensional genomic data and computational approaches to understand cellular and systems-level mechanisms the brain uses to monitor basic physiological needs. He earned a PhD in neuroscience from the University of Michigan and a bachelor’s degree in psychology and philosophy from the University of North Carolina at Chapel Hill.

Matt Knight

Senior Manager, Biopharma, Adaptive Biotechnologies

Matt Knight, PhD, has more than 10 years of research experience in microbiology and immunology, and specializes in helping clinical researchers and therapeutic developers incorporate Adaptive’s immunosequencing technology into their translational efforts. He has extensive experience in immunosequencing projects, including those in autoimmunity, immuno-oncology and vaccinology. He has also conducted antigen mapping work. Matt earned a PhD in microbiology from the University of California, Berkeley, where he studied T cell and macrophage responses to Mycobacterium tuberculosis infection.

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Kari Abitbol

Head of Webinars & Client Success, Endpoints News

As head of the client success team at Endpoints News, Kari oversees campaign delivery and strategy for all advertising and client-directed webinars. She brings nearly 20 years of diverse experience across strategic communications, content development and operational leadership.