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Engineered T Cell Therapies from a Drug Development Viewpoint

Engineering 2019年第1期5卷 140-149页

作者： Fang Chen Joseph A. Fraietta Carl H. June Zhongwei Xu J. Joseph Melenhorst Simon F. Lacey Department of Pathology and Laboratory Medicine University of Pennsylvania Philadelphia PA 19104 USA Center for Cellular Immunotherapies University of Pennsylvania Philadelphia PA 19104 USA Parker Institute for Cancer Immunotherapy University of Pennsylvania Philadelphia PA 19104 USA Abramson Cancer Center University of Pennsylvania Philadelphia PA 19104 USA Department of Immunology Peking University Beijing 100871 China

Cancer is one of the leading causes of death worldwide. Recent advances in cellular therapy have demonstrated that this platform has the potential to give patients with certain cancers a second chance at life. Unlike chemical compounds and proteins, cells are living, self-replicating drugs that can be engineered to possess exquisite specificity. For example, T cells can be genetically modified to express chimeric antigen receptors (CARs), endowing them with the capacity to recognize and kill tumor cells and form a memory pool that is ready to strike back against persisting malignant cells. Anti-cd19 chimeric antigen receptor T cells (CART19s) have demonstrated a remarkable degree of clinical efficacy for certain malignancies. The process of developing CART19 essentially follows the conventional “one gene, one drug, one disease” paradigm derived from Paul Ehrlich’s “magic bullet” concept. With major players within the pharmaceutical industry joining forces to commercialize this new category of “living drugs,” it is useful to use CART19 as an example to examine the similarities and differences in its development, compared with that of a conventional drug. In this way, we can assimilate existing knowledge and identify the most effective approach for advancing similar strategies. This article reviews the use of biomarker-based assays to guide the optimization of CAR constructs, preclinical studies, and the evaluation of clinical efficacy;adverse effects (AEs);and CART19 cellular kinetics. Advanced technologies and computational tools that enable the discovery of optimal targets, novel CAR binding domains, and biomarkers predicting clinical response and AEs are also discussed. We believe that the success of CART19 will lead to the development of other engineered T cell therapies in the same manner that the discovery of arsphenamine initiated the era of synthetic pharmaceuticals.

关键词： Engineered T cell therapies Chimeric antigen receptor Drug development process Biomarkers cd19-specific chimeric antigen receptor Anti-cd19 chimeric antigen receptor T cells

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