Agreements

Date: 2017-02-18

Type of information: Services contract

Compound: HLA-A2 CAR lentiviral vector

Company: Txcell (France)

Therapeutic area:

Type agreement: services

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:

Details:

• On December 18, 2017, TxCell announced it has completed the development of its first-generation production process for its proprietary CAR-Treg technology. The process will be transferred to a contract manufacturing organization (CMO) before the start of a first-in-man clinical trial. For its first CAR-Treg manufacturing process, TxCell has isolated a subset of Treg cells that have shown to be stable and to display a strong anti-inflammatory activity. Despite the rarity of the selected Treg subset, TxCell has successfully produced its CAR-Treg cellular product within two weeks (before post-production quality control). The company is currently finalizing its selection of the CMO for clinical supply of its lead HLA-A2 CAR?Treg product. Once CMO contractual agreements are executed, the transfer of TxCell’s manufacturing process will follow immediately. A regulatory dossier to start a first-in-man study is expected to be filed in Q4 2018. The start of clinical development will be subject to regulatory approval and availability of appropriate funding.
The CAR-Treg manufacturing process developed by TxCell for the HLA-A2 CAR-Treg candidate will be applicable to its portfolio of other CD4+FoxP3+ products. The CD4+FoxP3+ Treg population is one of the three Treg populations TxCell is working on. The other two are CD8+FoxP3+ Tregs and Type 1 Tregs (Tr1).

Financial terms:

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