This Research Topic is the second volume of the “Personalized Immunotherapy: Advancingprocesses to extend patient collectives” Community Series. Please see Volume I here.Cancer Immunotherapy apart from checkpoint inhibitors is a highly personalized medicine that puts the patient's cells in the focus of drug manufacturing and promises outcomes that rarely have been seen in the history of cancer treatment. CAR-T cells can be mentioned here as the key example that has gained FDA and EMA approvals as the first living drugs for the treatment of leukemias and is now under clinical investigation for application in solid tumors as well. Improvements in cellular engineering in combination with advanced sequencing methods have made it possible to discover tumor-mutation-specific T-cell receptors that can be used to redirect effector cells toward the malignant cell pool with high specificity. This approach opens the opportunity to drug driver mutations that are occurring in a group of patients as well as to design unique patient individual treatment regimens.Although cellular immunotherapy achieves good outcomes, only a minority of patients are treated with this advanced drug, and waitlists for receiving the approved products are incredibly long. Additionally, centralized manufacturing of individualized products results in complex logistic chains and drives drug costs. Designing a personalized cellular treatment is still a very laborious process that until now lacks harmonization. On top of that, this novel class of drugs, widely labelled as “Advanced Therapy Medicinal Products” (ATMPs), are not yet well regulated as they do not fall under a pre-defined category of drug substances.The goal of this research topic is to gain knowledge from scientific works that focus on approaches and ideas to broaden patients´ access to cellular immunotherapies. This will include a broad range of multi-disciplinary research ranging from the identification of novel targets to drug manufacturing and regulatory issues. We aim on giving a comprehensive summary of the state of the art and make implications for future treatment modalities.We encourage authors from all fields of clinical translational research and related areas that are in touch with cellular immunotherapies to hand in their original research papers, reviews, or perspectives/essays. This topic targets active clinicians, basic researchers, health economists, and health policy investigators. We expect submissions related (but not limited) to:• Application of CARs, TILs, tgTCRs in clinical and preclinical studies (Original Research)• Advancements in ATMP manufacturing processes including QC (Original Research, Reviews)• Novel aspects in regulatory issues, cost reduction, reimbursement options, and healtheconomy. (Original research, Reviews, Essays)• Research in target discovery of (neo)antigens. (Original Research)Topic Editors: Dr. Jonathan A. Scolnick is employed by Singleron Biotechnologies, which produces and sells products for single-cell gene expression analysis, and Dr. Stefan Eichmüller is currently consulting Genovo Coorp to help them set up a GMP TILs production unit.Manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) are out of scope for this section and will not be accepted as part of this Research Topic.
This Research Topic is the second volume of the “Personalized Immunotherapy: Advancingprocesses to extend patient collectives” Community Series. Please see Volume I here.Cancer Immunotherapy apart from checkpoint inhibitors is a highly personalized medicine that puts the patient's cells in the focus of drug manufacturing and promises outcomes that rarely have been seen in the history of cancer treatment. CAR-T cells can be mentioned here as the key example that has gained FDA and EMA approvals as the first living drugs for the treatment of leukemias and is now under clinical investigation for application in solid tumors as well. Improvements in cellular engineering in combination with advanced sequencing methods have made it possible to discover tumor-mutation-specific T-cell receptors that can be used to redirect effector cells toward the malignant cell pool with high specificity. This approach opens the opportunity to drug driver mutations that are occurring in a group of patients as well as to design unique patient individual treatment regimens.Although cellular immunotherapy achieves good outcomes, only a minority of patients are treated with this advanced drug, and waitlists for receiving the approved products are incredibly long. Additionally, centralized manufacturing of individualized products results in complex logistic chains and drives drug costs. Designing a personalized cellular treatment is still a very laborious process that until now lacks harmonization. On top of that, this novel class of drugs, widely labelled as “Advanced Therapy Medicinal Products” (ATMPs), are not yet well regulated as they do not fall under a pre-defined category of drug substances.The goal of this research topic is to gain knowledge from scientific works that focus on approaches and ideas to broaden patients´ access to cellular immunotherapies. This will include a broad range of multi-disciplinary research ranging from the identification of novel targets to drug manufacturing and regulatory issues. We aim on giving a comprehensive summary of the state of the art and make implications for future treatment modalities.We encourage authors from all fields of clinical translational research and related areas that are in touch with cellular immunotherapies to hand in their original research papers, reviews, or perspectives/essays. This topic targets active clinicians, basic researchers, health economists, and health policy investigators. We expect submissions related (but not limited) to:• Application of CARs, TILs, tgTCRs in clinical and preclinical studies (Original Research)• Advancements in ATMP manufacturing processes including QC (Original Research, Reviews)• Novel aspects in regulatory issues, cost reduction, reimbursement options, and healtheconomy. (Original research, Reviews, Essays)• Research in target discovery of (neo)antigens. (Original Research)Topic Editors: Dr. Jonathan A. Scolnick is employed by Singleron Biotechnologies, which produces and sells products for single-cell gene expression analysis, and Dr. Stefan Eichmüller is currently consulting Genovo Coorp to help them set up a GMP TILs production unit.Manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by validation (independent cohort or biological validation in vitro or in vivo) are out of scope for this section and will not be accepted as part of this Research Topic.