Date: 2017-06-19
Type of information: Services contract
Compound: HLA-A2 CAR lentiviral vector
Company: Txcell (France) Lentigen Technology (USA - MD), a wholly owned subsidiary of Miltenyi Biotech (Germany)
Therapeutic area: Transplantation
Type agreement:
- services contract - manufacturing - production
Action mechanism:
- cell therapy/immunotherapy product/gene therapy/CAR-T cell therapy. The HLA-A2 CAR lentiviral vector will be used to manufacture TxCell's CAR-Tregs targeting transplant rejection. This candidate targets the prevention of chronic rejection after organ transplantation. It is expected to enter clinical studies by the end of 2018. HLA-A2 CAR-Treg cells are designed to specifically recognize an HLA-A2+ graft and trigger a reduction of the inflammation as well as an induction of immune tolerance in a local and specific manner, thereby reducing graft rejection.
TxCell is working with two leading academic partners for this program, the University of British Columbia (UBC) in Vancouver, Canada and the Center for Research in Transplantation and Immunology (CRTI) in Nantes, France. These collaborations are exploring two different subtypes of Treg cells, CD4+ and CD8+, respectively.
Disease: prevention of chronic rejection after organ transplantation
Details:
Financial terms:
Latest news:
- • On June 19, 2017, TxCell announced the signing of a strategic agreement with Lentigen Technology, a wholly-owned subsidiary of Miltenyi Biotec. This agreement appoints Lentigen 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.
- As per the terms of this agreement, Lentigen will be responsible for the production, under Good Manufacturing Practice (GMP) conditions, of the HLA-A2 CAR lentiviral vector clinical batches. Prior to that, the company 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. Lentigen 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.
Is general: Yes
