Date: 2016-06-19
Type of information: Services contract
Compound: HLA-A2 CAR lentiviral vector
Company: Txcell (France) Lentigen Technology , a wholly-owned subsidiary of Miltenyi Biotec (Germany)
Therapeutic area: Transplantation
Type agreement:
- services contrat - manufacturing - bioproduction
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 CAR-Treg product-candidate targets the prevention of chronic rejection after organ transplantation. 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.
Disease: prevention of chronic rejection after organ transplantation.
Details:
- • 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 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. This candidate 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.
- 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.
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