ImmunoCellular Therapeutics Chooses PharmaCell as Contract Manufacturing Partner for Its Phase III Program in Europe
Maastricht, The Netherlands, March 19, 2015 / B3C newswire / -- PharmaCell B.V. a leading Contract Manufacturing Organization for Cellular Therapies and Regenerative Medicine in Europe, announced today that it finalized an agreement with ImmunoCellular Therapeutics Ltd. to support its pivotal phase III clinical trial in Europe with ICT-107. ICT 107 is a dendritic cell-based vaccine developed for glioblastoma multiforme, one of the commonest and deadliest forms of brain cancer. Under the terms of the agreement, PharmaCell will perform a Technology Transfer from its US-based contract manufacturing partner to its newly acquired Geleen facility (The Netherlands), and support the subsequent clinical trial with ICT-107.
Andrew Gengos, Chief Executive Officer of ImmunoCellular Therapeutics explained: "We are pleased to engage with PharmaCell who have a proven ability to support companies in establishing a robust manufacturing capability in Europe in line with the strict standards of the regulatory authorities for Phase III and early stage commercial manufacturing for ATMPs (Advanced Therapy Medicinal Products)."
Alexander Vos, Chief Executive Officer of PharmaCell BV, said: "We are excited that ImmunoCellular Therapeutics, a global leader in cancer immunotherapy, have decided to work with us. Their decision confirms that our new Geleen facility is indeed viewed by industry experts as meeting the requirements and client expectations for late clinical stage and commercial manufacturing for ATMPs. We look forward to support ImmunoCellular in their effort to develop ICT-107 for the benefit of European patients."
PharmaCell is a leading European-based CMO exclusively focused in the area of cell therapy and regenerative medicine. PharmaCell has experience in supporting Phase I through Phase III clinical trials and early commercial manufacturing in cell therapy in terms of manufacturing, Quality Control, storage, in-outgoing logistics and product release through its in-house QPs. Its services also include process and assay-development to ensure GMP compliance, robustness and scalability of cell therapy manufacturing processes. PharmaCell offers a unique manufacturing platform in Europe to support the growth of the cell therapy and regenerative medicine industry by means of its facility in Maastricht for early stage clinical trials and its Geleen facility fully equipped for late clinical stage and commercial scale manufacturing. Both manufacturing sites are GMP-licensed and inspected by EMA for commercial production of ATMPs.
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 II trial of its lead product candidate, ICT-107, a dendritic cell-based cancer immunotherapy targeting multiple tumor-associated antigens for glioblastoma. ImmunoCellular's pipeline also includes: ICT-121, a dendritic cell immunotherapy targeting CD133; ICT-140, a dendritic cell immunotherapy targeting ovarian cancer antigens and 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.