ImmunoCellular Therapeutics (OTCBB: IMUC), a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it has developed an innovative method for manufacturing the company's lead product candidate, ICT-107, a dendritic cell-based vaccine for the treatment of glioblastoma multiforme (GBM). The method was developed in collaboration with the Clinical Cell and Vaccine Production Facility at the University of Pennsylvania.
“We continue to conduct analyses on the significant per-dose manufacturing-cost savings of this new method as we prepare to initiate a Phase II study of ICT-107 in GBM in the fourth quarter of this year.”
The new method employs a closed-bag system designed to produce highly potent dendritic cells from white blood cells collected from patients, and for subsequently cryopreserving the dendritic cells for future vaccine treatments. The process has also been optimized to produce high levels of certain cytokines which are correlative of dendritic cells' ability to boost immune response.
Engineering and validation runs have confirmed that this process may be used to produce 20 or more doses of ICT-107 vaccine from a single blood collection, which may be frozen and later used for vaccination and maintenance of immune response in patients until disease recurrence.
"The validated method we have optimized for producing 20 or more doses of dendritic cell-based vaccine from a single blood collection presents significant cost and convenience advantages over current manufacturing methods, as patients should be able to be treated for several years from a single manufacturing run. For example, Provenge®—another dendritic cell-based vaccine approved for prostate cancer—is manufactured one dose at a time, contributing to its very expensive treatment cost," said Manish Singh, Ph.D., president and CEO of ImmunoCellular Therapeutics. "We continue to conduct analyses on the significant per-dose manufacturing-cost savings of this new method as we prepare to initiate a Phase II study of ICT-107 in GBM in the fourth quarter of this year."
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