New York (June 15, 2015) – Caladrius Biosciences, Inc. (Nasdaq:CLBS) (“Caladrius”), a cell therapy leader with a late-stage clinical program for immuno-oncology, announced today a new Agreement between its wholly-owned subsidiary, PCT, LLC, a Caladrius Company (“PCT”), and ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT:IMUC), a clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers.
Under this Agreement, PCT will produce ICT-107, a dendritic cell-based immunotherapy targeting six glioblastoma tumor-associated antigens, for a pivotal Phase 3 trial in patients with newly diagnosed glioblastoma. PCT has served as an external manufacturing and development provider for ImmunoCellular since 2011, including clinical production for ImmunoCellular’s ICT-107 Phase 2 trial.
PCT will provide manufacturing services, including processing, packaging, labelling, quality control testing, release, shipping and storage, as well as process requalification, for ICT-107. The agreement includes the provision of a semi-dedicated controlled environment room and staff to meet ImmunoCellular’s Phase 3 manufacturing needs. Furthermore, ImmunoCellular will make use of PCT’s capability to perform a technology transfer process to harmonize the EU and US methods of production of ICT-107.
“Ensuring that ImmunoCellular has US manufacturing capacity that can fully support our ICT-107 phase 3 registration program, and potentially include commercial manufacturing, is an important step toward initiation of our Phase 3 registration program,” said Andrew Gengos, ImmunoCellular Chief Executive Officer.
“We are extremely pleased that the leadership team at ImmunoCellular, like a number of our clients, has chosen to develop a long-term relationship partnership with PCT in order to maintain the cell therapy manufacturing reliability, quality, and cost efficiencies they have come to expect,” said Dr. Robert A. Preti, President of PCT, and Chief Technology Officer of Caladrius. “We feel our clients significantly reduce their clinical development risk by manufacturing with PCT and leveraging our Innovation and Quality infrastructure.”
About Caladrius Biosciences, Inc. (formerly NeoStem, Inc.)
Caladrius Biosciences, Inc. is among the first of a new breed of immunotherapy companies with proven expertise and unique experience in cell process optimization, development, and manufacturing. Caladrius is a cell therapy leader with late-stage clinical programs based on a proprietary platform technology for immuno-oncology, as well as additional platform technologies for ischemic repair and immunomodulation, and capabilities that support other cell therapy developers. This integrated approach supports the industry in bringing significant life-improving medical treatments to market. www.caladrius.com
About ImmunoCellular Therapeutics, Ltd.
ImmunoCellular Therapeutics, Ltd. is a Los Angeles-based clinical stage company that is developing immune-based therapies for the treatment of brain and other cancers. ImmunoCellular has concluded a phase 2 trial of its lead product candidate, ICT-107, a dendritic cell-based immunotherapy targeting multiple tumor-associated antigens on glioblastoma stem cells. ImmunoCellular’s pipeline also includes: ICT-121, a dendritic cell immunotherapy targeting the CD133 antigen on stem cells in recurrent glioblastoma; ICT-140, a dendritic cell immunotherapy targeting antigens on ovarian cancer stem cells; and the Stem-to-T-cell research program which engineers the patient’s hematopoietic stem cells to generate antigen-specific cancer-killing T-cells. To learn more about ImmunoCellular, please visit www.imuc.com.
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