摘要
As of May 1, 2017, 74 antibody-based molecules have been approved by a regulatory authority in a major market. Additionally, there are 70 and 575 antibody- based molecules in phase III and phase 1/11 clinical trials, respectively. These total 719 antibody-based clinical stage molecules include 493 naked IgGs, 87 antibody- drug conjugates, 61 bispecific antibodies, 37 total Fc fusion proteins, 17 radioimmunoglobulins, 13 antibody fragments, and 11 immunocytokines. New uses for these antibodies are being discovered each year. For oncol- ogy, many of the exciting new approaches involve anti- body modulation of T-cells. There are over 80 antibodies in clinical trials targeting T cell checkpoints, 26 T-cell- redirected bispecific antibodies, and 145 chimeric anti- gen receptor （CAR） cell-based candidates （all currently in phase I or II clinical trials）, totaling more than 250 T cell interacting clinical stage antibody-based candi- dates. Finally, significant progress has been made recently on routes of delivery, including delivery of proteins across the blood-brain barrier, oral delivery to the gut, delivery to the cellular cytosol, and gene- and viral-based delivery of antibodies. Thus, there are cur- rently at least 864 antibody-based clinical stage mole- cules or cells, with incredible diversity in how they are constructed and what activities they impart. These are followed by a next wave of novel molecules, approa- ches, and new methods and routes of delivery, demon- strating that the field of antibody-based biologics is very innovative and diverse in its approaches to fulfill their promise to treat unmet medical needs.
As of May 1, 2017, 74 antibody-based molecules have been approved by a regulatory authority in a major market. Additionally, there are 70 and 575 antibody- based molecules in phase III and phase 1/11 clinical trials, respectively. These total 719 antibody-based clinical stage molecules include 493 naked IgGs, 87 antibody- drug conjugates, 61 bispecific antibodies, 37 total Fc fusion proteins, 17 radioimmunoglobulins, 13 antibody fragments, and 11 immunocytokines. New uses for these antibodies are being discovered each year. For oncol- ogy, many of the exciting new approaches involve anti- body modulation of T-cells. There are over 80 antibodies in clinical trials targeting T cell checkpoints, 26 T-cell- redirected bispecific antibodies, and 145 chimeric anti- gen receptor （CAR） cell-based candidates （all currently in phase I or II clinical trials）, totaling more than 250 T cell interacting clinical stage antibody-based candi- dates. Finally, significant progress has been made recently on routes of delivery, including delivery of proteins across the blood-brain barrier, oral delivery to the gut, delivery to the cellular cytosol, and gene- and viral-based delivery of antibodies. Thus, there are cur- rently at least 864 antibody-based clinical stage mole- cules or cells, with incredible diversity in how they are constructed and what activities they impart. These are followed by a next wave of novel molecules, approa- ches, and new methods and routes of delivery, demon- strating that the field of antibody-based biologics is very innovative and diverse in its approaches to fulfill their promise to treat unmet medical needs.
