Clinical development of TxCell’s new technology on track to start by end of 2018
Valbonne, France, June 19, 2017, 5.45pm CEST
TxCell SA (FR0010127662 – TXCL), a biotechnology company developing innovative, personalized cellular immunotherapies using regulatory T cells (Treg) to treat severe inflammatory and autoimmune diseases as well as transplant rejection, today announces the signing of a strategic agreement with Lentigen Technology, Inc. (LTI), a wholly-owned subsidiary of Miltenyi Biotec GmbH. This agreement appoints LTI as TxCell’s contract manufacturing organization (CMO) for the GMP production of its HLA-A2 CAR lentiviral vector. This vector will be used to manufacture TxCell’s CAR-Tregs targeting transplant rejection.
TxCell’s lead CAR-Treg product-candidate targets the prevention of chronic rejection after organ transplantation, a significant unmet medical need. It is expected to enter clinical studies by the end of 2018. The objective of the first-in-man study, to be conducted in the setting of solid organ transplantation (lung and/or kidney), would be to assess the toxicity profile of the selected HLA-A2 CAR-Treg candidate as well as to obtain a first evaluation of the control of inflammation-related markers and of the induction of tolerance. Transplant rejection is one of the key challenges of organ transplantation. In 2014, the global market of immunosuppressant drugs used in transplantation was estimated to be $5.1 billion.
As per the terms of the agreement announced today, Lentigen, a Miltenyi Biotec Company, will be responsible for the production, under Good Manufacturing Practice (GMP) conditions, of the HLA-A2 CAR lentiviral vector clinical batches. Prior to that, LTI will produce smaller quantities of the HLA-A2 CAR lentiviral vector for IND-enabling preclinical studies. These will be conducted with the humanized CAR-Treg candidate selected for future clinical development.
TxCell is also in the process of selecting a second CMO, which will be responsible for the production of the cellular therapy drug product. TxCell is developing a proprietary manufacturing process for CAR-Treg cells and expects to start the technology transfer to the selected cell therapy CMO by the end of 2017. LTI will be responsible for transferring the HLA-A2 CAR clinical batch to the cell therapy CMO for the clinical manufacturing of HLA-A2 CAR-Treg cells to be used in the first-in-man study.
“TxCell’s process development team has made significant progress in the last 12 months in developing a manufacturing process for our CAR-Tregs products. The GMP development of the specific viral vector is a critical step for this development,” said Stéphane Boissel, CEO of TxCell. “Lentigen’s expertise in producing GMP lentiviral vectors for the pharma and biotech industry is widely recognized. This appointment has enabled TxCell to ensure that its first-in-man CAR-Treg study can start by the end of 2018 as previously announced. CAR-Tregs have yet to be tested in clinical studies and TxCell is looking forward to pioneering this promising field. Our objective with this first-in-man study is to obtain by 2020 a clinical proof-of-concept of our CAR-Treg platform, which has the potential to be used in a wide range of applications beyond transplantation, notably in severe chronic autoimmune and inflammatory disorders.”
“Lentiviral vectors are a critical component in the CAR-T cell manufacturing process. Their seamless and cost-effective integration into ex vivo cell manufacturing is very important for commercial success. As a result, Lentigen has successfully developed a large-scale chemically-defined, serum-free suspension bioreactor lentiviral vector manufacturing process to meet that goal,” said Boro Dropulic, General Manager and Chief Science Officer of Lentigen Technology, Inc. “We are excited to support TxCell by manufacturing lentiviral vectors for its first-ever CAR-Treg clinical trial – thus helping TxCell’s innovative cellular therapy approach to become clinical practice.”
For more information on Lentigen or on TxCell's CAR-Treg transplantation program, please download the full press release in PDF.