The University of Pennsylvania has agreed to support process development and manufacturing in a Phase II trial of ImmunoCellular Therapeutics’ ICT-107, a dendritic-cell based cancer vaccine for the treatment of glioblastoma multiforme (GBM). The goal is to increase yields such that, in a single manufacturing run, enough doses could be produced for 2–3 years of each patient’s vaccination.
The partners believe that this will reduce the cost of manufacturing of each dose significantly. In addition, the optioned dendritic-cell production technologies developed at UPenn could result in a higher potency as well as reduced time to manufacture these vaccines, ImmunoCellular Therapeutics notes.
ICT-107 is a dendritic-cell based vaccine that works by activating a patient's immune system against specific tumor-associated antigens. This is accomplished by extracting dendritic cells from a patient, loading them with the antigens, and re-introducing them to the patient's body to trigger an immune response.
The Phase I study of ICT-107 in GBM was conducted in newly diagnosed patients. Those who received the vaccine demonstrated a median progression-free survival (PFS) of 17.7 months after surgery, while the historical median PFS is 6.9 months. Seven of the 16 patients (43.75%) who participated in the study continue to live with no disease progression with an average time of over 2 years; historical data puts disease-free survival at less than 15%.
The six tumor-associated antigens used in ICT-107 are AIM2, Her-2/neu, gp-100, MAGE-1, TRP-2, and IL13Ra2. These antigens are highly expressed in GBM as well as a number of other types of cancer, including breast, ovarian, colon, and melanoma. In addition, three of these antigens are highly expressed on cancer stem cells. ICT-107 may, therefore, be potentially applicable to multiple cancer types and may target both the bulk of the tumor as well as cancer stem cells, ImmunoCellular Therapeutics reports.
The company also has another immunotherapy called ICT-121. It reportedly targets cancer stem cells and is being tested in GBM and other cancer indications. ICT-121 is targeted to enter clinical trials for GBM during the second half of this year.
Additionally, the company has entered into a research and license option deal with Roche for one of its mAb candidates for the diagnosis and treatment of ovarian cancer and multiple myeloma, which provides for potential licensing and milestone payments of $32 million. In total the company has three mAbs in preclinical development against various types of cancer and one in development specifically as a diagnostic/prognostic tool.