The California Institute for Regenerative Medicine (CIRM) has awarded a $19.9m grant to ImmunoCellular Therapeutics to support the phase 3 clinical trial of ICT-107 in patients with newly diagnosed glioblastoma.
The institute granted the funding under its CIRM 2.0 program, which is designed to speed up the development of stem cell-based treatments for people with unmet medical requirements.
ICT-107 is being developed specifically as an immunotherapy that targets and kills tumor stem cells in order to avoid tumor recurrence after standard-of-care treatment.
The phase 3 ICT-107 trial is planned to be carried out in the fourth quarter of this year on 400 patients at about 120 clinical sites in the US, Europe and Canada.
ImmunoCellular signed an agreement with the US FDA on a special protocol assessment regarding the primary and secondary endpoints as well as the trial’s statistical plan.
The expected final data collection for the primary endpoint is December 2019, while the study is planned to be finished in December 2021.
ImmunoCellular president and CEO Andrew Gengos said: "We are excited to be close to initiating our phase 3 registration trial. With this important grant of non-dilutive capital and our current cash, we are in position to cover the full external cost of conducting the trial and ensure high quality trial execution.
"Our strategic focus going forward will be on advancing our Stem-to-T-cell immunotherapy platform and pursuing additional related technologies to grow our pipeline – strategies that are key to achieving our goal of building a leading cancer immunotherapy company."
ICT-107 is an autologous dendritic cell immunotherapeutic that targets six different antigens related with glioblastoma, the most common and lethal form of brain cancer.
ImmunoCellular said four of the tumor-associated antigens are highly expressed on cancer stem cells (CSCs). ICT-107 is designed for use after surgical tumor resection of newly diagnosed glioblastoma in combination with standard treatment of radiation and chemotherapy.