ImmunoCellular Therapeutics has decided to use Progenitor Cell Therapy (PCT) to produce its Phase II glioblastoma vaccine, ICT-107. PCT's cGMP plant in Mountain View, CA, will serve as a second manufacturing site for this dendritic cell-based vaccine. It will be responsible for supplying the drug for Phase II study as well as future trials.
“PCT's competencies in autologous cell therapies, cell manufacturing, cell processing, and delivery make it ideally suited as a manufacturer for ImmunoCellular Therapeutics as we look forward to completing this Phase II trial and seek to secure a strategic partner in connection with a future potential Phase III trial for ICT-107 and its commercialization,” states Manish Singh, Ph.D., ImmunoCellular Therapeutics president and CEO.
ICT-107 targets multiple tumor associated antigens. The dendritic cells are harvested from patients, then programmed to attack tumor-specific antigens before they are injected them back into patients’ bodies. In an earlier Phase I study, GBM patients who received ICT-107 in addition to standard treatment with surgery, radiation, and chemotherapy had significantly longer disease-free survival than is typically expected with standard treatment alone.
PCT served as primary manufacturer for Dendreon during seven years of clinical trials for its prostate cancer cell-based treatment, Provenge. "PCT's unique expertise in manufacturing, regulatory, logistical transport, and commercialization for therapeutics development, with its East and West Coast facilities, result in clients feeling great comfort entrusting their therapeutics to PCT," points out Robin L. Smith, M.D., chairman and CEO of NeoStem, PCT's parent firm.