The Late-Stage Industry Pipeline
The pipeline of industry-sponsored cell-based immunotherapies is rich and encouragingly mature with no less than 13 late-stage trials (11 Phase III trials and two listed as Phase II/III trials). Just over half of trials are expected to complete, release data, or reach significant completion milestones within the next 12 months. All but three trials are expected to be complete by Q4 2015.
Geographically the trials are almost perfectly split between those in the U.S. (3), U.S. and Europe (3), Europe (3), and South Korea (4). All trials are pursuing oncology-related targets, although two are targeting treatment-related complications—cancer is at the forefront of personalized medicine, and immunotherapy is no exception.
While all cell-based immunotherapies belong in the same class as the autologous, dendritic cell-based Provenge, many differ in significant ways. While 70% of the industry-sponsored late-stage trials utilize autologous cells, 46% utilize allogeneic cells (one involves both), and 30% involve gene-modification. Just less than half utilize dendritic cells while the others employ other immunotherapy cell agents including NK cells, lymphocytes, and allogeneic tumor cell lines.
While space does not permit us to review each of these trials and compounds in any detail, the sponsors include Argos Therapeutics, Cell Medica, Innocell, JW Creagene, MolMed, Newlink Genetics, NK Bio, Neurovita Clinic, Northwest Biotherapeutics, NovaRx, Prima Biomed, and SOTIO. Further details can be found in a recent post on www.celltherapyblog.com.