ImmunoCellular Therapeutics (IMUC) says that the transfer of technology from the University of Pennsylvania to a second manufacturing site is complete. Last October, IMUC entered into an arrangement with Progenitor Cell Therapy (PCT) to produce ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma (GBM), for IMUC’s Phase II trial.
Technology was transferred from the University of Pennsylvania to the second manufacturing site at PCT’s Mountain View, CA, facility. Qualification runs demonstrated equivalent processes and the ability to produce ICT-107 at multiple locations. This will allow for significantly increased production and will mitigate site-specific risks by spreading the manufacturing process to multiple locations, IMUC points out. It will also allow more patients to be treated each week.
PCT’s California facility may also be used to support a Phase III trial as well as the commercialization of ICT-107. “We are pleased to bring our second manufacturing site online, which will increase our ability to produce ICT-107,” says Manish Singh, Ph.D., president and CEO of IMUC. “We continue to focus on enrolling and dosing patients efficiently." IMUC has enlisted 166 patients in its ongoing Phase II study of ICT-107 in GBM. The trial expects to enroll about 200 patients in order to treat 102 patients with HLA-A1/A2 immunological subtypes.
In the Phase I study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard-of-care treatment of surgery, radiation, and chemotherapy demonstrated two-year overall survival of 80% and a three-year overall survival of 55%. These figures compare favorably to the current 26% two-year overall survival and 16% three-year overall survival based on the historical standard-of-care treatment alone, IMUC points out.
The median overall survival was 38.4 months compared to the current 14.6 months for the historical standard-of-care treatment. The study achieved a median progression free survival (PFS) of 16.9 months, while the historic median PFS is 6.9 months. Six out of the 16 (37.6%) newly diagnosed patients who received ICT-107 in the Phase I trial continued to show no tumor recurrence at the last analysis, with three of these patients (18.8%) remaining disease-free for more than four years and the other three patients going more than three years disease-free.