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PCT, ImmunoCellular Expand Manufacturing Pact



Published December 3, 2013
Related Searches: Development Services Phase II Vaccine Phase III
NeoStem, Inc.’s subsidiary, Progenitor Cell Therapy (PCT), has expanded its manufacturing partnership with ImmunoCellular Therapeutics for cGMP and development services for ImmunoCellular's dendritic cell-based vaccines. PCT currently manufactures ICT-121, a dendritic cell vaccine targeting CD133 cells, which is in Phase I development for recurrent glioblastoma multiforme (GBM). PCT also manufactured Phase II clinical supplies of ICT-107, a dendritic cell-based vaccine targeting six tumor-associated antigens for newly diagnosed GBM.
 
Under the new agreement, PCT will manufacture clinical supplies of ICT-140, a dendritic cell vaccine targeting seven ovarian cancer antigens. Additionally, PCT will employ process improvements that can be applied to the manufacture of all ImmunoCellular's current vaccine product candidates. These improvements aim to increase quality, consistency, efficiency, and cost-effectiveness to support ImmunoCellular's vaccine manufacturing requirements for potential Phase III registration trials and commercial manufacture upon approval.
 
"Ensuring that ImmunoCellular has an established manufacturing process that can support pivotal registration programs and eventual commercial manufacturing for all our dendritic cell vaccines as they advance toward registration is foundational for building a leading cancer immunotherapy company," said Andrew Gengos, ImmunoCellular chief executive officer. "We look forward to continuing our partnership with PCT, and are pleased to be making this investment in process enhancements now."
 
"We appreciate the opportunity to begin yet another project with ImmunoCellular as a manufacturing and development partner," said Robert A. Preti, Ph.D., president of PCT and chief scientific officer of NeoStem. "PCT has developed significant expertise in the development and manufacture of dendritic cell vaccines, as well as other immunotherapies, over its 15-year history, including the experience of our long-term service for Dendreon, for whom we provided manufacturing through pivotal studies of Provenge, the first cell therapy approved for cancer treatment."


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