
ImmunoCellular awarded $19.9 million grant for ICT-107 phase 3 trial for glioblastoma
pharmafile | September 25, 2015 | News story | Research and Development | California Institute for Regenerative Medicine, Cancer, ICT-107, brain cancer, glioblastoma
ImmunoCellular Therapeutics has been awarded a $19.9 million grant by California Institute for Regenerative Medicine (CIRM), California’s stem cell agency, to support its phase 3 registration trial for ICT-107 in patients with newly-diagnosed glioblastoma.
Glioblastoma is the most common and aggressive form of malignant brain tumour, and is difficult to treat due to the many variations of cell types that make up the tumour. According to the American Brain Tumour Association, with the current standard treatment, median survival for adults is about 14.6 months and two-year survival just 30%. Fewer than 10% of patients live for five years.
The $19.9 million was granted under the CIRM 2.0 program, a collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs.
ImmunoCellular’s ICT-107 vaccine qualified for grant consideration on the basis of being specifically engineered as an immunotherapy that preferentially targets and kills cancer tumor stem cells with the goal of preventing tumor recurrence following standard-of-care treatment.
In a 2012 phase I clinical study of ICT-107, 16 newly-diagnosed patients who received the vaccine in addition to standard of care treatment of surgery, radiation and chemotherapy demonstrated a two-year overall survival of 80%, representing a significant improvement on the standard treatments alone.
ImmunoCellular says it will present updated data from the phase 2 ICT-107 trial at the Society for Neuro-Oncology (SNO) meeting in November 2015.
The company is set to begin the phase 3 ICT-107 trial in the fourth quarter of 2015, which will include approximately 120 clinical sites in the US, Europe and Canada, and recruit about 400 patients.
The $19.9 million CIRM grant funds will be received by the Company over the duration of the trial as specified milestones are achieved.
Andrew Gengos, ImmunoCellular president and chief executive, says: “We are deeply appreciative to CIRM for their generous support and validation of the therapeutic potential of our ICT-107 dendritic cell-based immunotherapy. We share CIRM’s commitment to advancing potential breakthrough stem cell-based therapies to patients with unmet medical needs.
“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.”
Joel Levy
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