Admission of the new technology of TxCell still expected by the end of 2018
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Valbonne, France, June 19, 2017 TxCell SA (FR0010127662 TXCL), a company of biotechnology which develops immunotherapies cellular custom innovative from regulatory T cells (Tregs) for the treatment of inflammatory diseases and autoimmune diseases severe and transplant rejection, today announced the signing of a strategic agreement with Lentigen Technology, Inc. (LTI), a subsidiary 100% owned by Miltenyi Biotec GmbH. According to the terms of this agreement, TxCell has selected LTI as a Contract Manufacturing Organization (CMO) for the production, in conditions compliant with Good Manufacturing Practices (GMP), lentiviral vector for the BECAUSE HLA-A2. This vector will be used for the manufacture of the AS-Tregs from TxCell targeting the prevention of transplant rejection.
“In the last 12 months, the teams of TxCell have made significant progress in the development of a manufacturing process for our products BECAUSE-Treg. In this regard, the development under GMP conditions of viral vector ad hoc is a major step, ” said Stéphane Boissel, ceo of TxCell. “The expertise of Lentigen in the production of lentiviral vectors GMP for the pharmaceutical and biopharmaceutical industries is widely recognized. This strategic agreement allows TxCell to ensure that its first clinical study with a CAR-Treg will start by the end of 2018, as previously announced. The CAR-Tregs have not yet been tested in clinical and TxCell is looking forward to initiate this promising field. Our goal is to achieve by 2020 a clinical proof of concept for our platform, BECAUSE-Treg, which has the potential to be used in many therapeutic applications beyond transplantation, including autoimmune diseases and chronic inflammatory severe. ”
“Lentiviral vectors form a major component of the manufacturing process of the cells BECAUSE-T. Their integration within the workflow of cells ex vivo without any increase in the cost of production is very important for ensuring the commercial success of this type of products. To this end, we have developed a process for the manufacture of lentiviral vectors on a large scale in bioreactors, in suspension, and using a culture medium, serum-free, chemically defined, ” adds Boro Dropulic, Chief Executive officer and Chief Scientific officer of Lentigen Technology, Inc. “We are thrilled to support TxCell in manufacturing of lentiviral vectors for their clinical trial with a CAR-Treg cells, and thus participate in the entrance in clinical practice with his innovative approach to cellular immunotherapy. “
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