CiMaas & PharmaCell BV Enter Collaborative Agreement
CiMaas BV, a company developing cellular immunotherapy for cancer, and PharmaCell BV, a leading Contract Manufacturing Organization for Cellular Therapies and Regenerative Medicine in Europe, have agreed to collaborate in the clinical development of CiMaas’ products. Under the agreement, PharmaCell will provide consulting services on writing GMP-compliant documents for the purpose of translating the CiMaas cell therapy processes into GMP. Options have been taken on a full technology transfer trajectory to be started and executed at a later date. A continuation option on a Phase I and possibly a Phase II clinical trial is also part of the agreement.
Gerard Bos, Chief Executive Officer of CiMaas said: “We are delighted to collaborate with PharmaCell and receive support in building our documents and technology in a fully GMP compliant manner for the development of our ATMPs (Advanced Therapy Medicinal Products).” Wilfred Germeraad, Chief Scientific Officer added: “It is a wonderful opportunity to work together and it will immediately speed-up our work in translating the lab procedures into clinical products ready to be tested in patients with cancer.”
Alexander Vos, Chief Executive Officer of PharmaCell BV, said: “The CiMaas team has shown to be successful in bringing their technology to the point of preparing the initiation of clinical studies. We are excited to support them to make their production process GMP-compliant and help clear the path to bring their innovative therapies to benefit patients.”
CiMaas BV aims to develop cellular immunotherapy for specific groups of cancer patients. The company will focus on the development of two unique products: a cancer vaccine using the patient’s own immune (dendritic) cells and the production of donor natural killer cells. These methods can help to treat many oncological diseases. CiMaas will initially focus on lung cancer and multiple myeloma (MM, a type of bone marrow cancer also known as Kahler’s disease). Both will be clinically tested in patients from January 2017. CiMaas (Cellular Immunotherapy Maastricht) is a spin-off of Maastricht University/Maastricht University Medical Centre+ (UM/Maastricht UMC+).
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.
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