Valbonne, France, January 17, 2018, 5.45pm CET
TxCell SA (FR0010127662 – TXCL), a developer of cellular immunotherapies based on regulatory T cells (Tregs) for inflammation, autoimmunity and transplantation, today announces it has obtained an interest-free loan from Bpifrance, a French government agency, for the preclinical development of its most advanced CAR-Treg program. The €1.2 million funding represents circa 25% (50% of eligible costs) of a broad program covering the preclinical and non-clinical pharmaceutical development of TxCell’s HLA-A2 CAR-Treg cellular therapy product for the prevention of chronic rejection after solid organ transplantation. Costs related to the preclinical phase of the program are approximately €5 million, including the cost of transferring the technology to a Contract Manufacturing Organization (CMO).
The Bpifrance loan is an interest-free innovation loan entitled ‘Prêt à Taux Zéro pour l’Innovation’ (PTZI)1. This financing instrument serves to support companies to develop innovative products with real commercial potential. Additional information is available on the Bpifrance website.
“The €1.2 million loan from Bpifrance comes at a time when TxCell is entering a decisive year,” said Raphaël Flipo, CFO of TxCell. “It provides us with additional means to advance our lead CAR-Treg program targeting HLA-A2 through preclinical development, and set the stage for the first-in-man study. An alternative therapeutic option to prevent chronic rejection in transplanted patients remains an area of significant unmet need.”
About TxCell’s transplantation CAR-Treg program
TxCell’s most advanced CAR Treg program targets the prevention of chronic rejection after organ transplantation. Transplant rejection remains one of the major challenges in transplantation. In the case of kidney transplants, graft survival is only 50% at ten years2. In the case of lung transplants, the mortality rate remains high (40-55% at five years)3. As an alternative to non-specific immunosuppression, TxCell’s CAR-Treg approach aims to induce immune tolerance to the graft in a local and specific manner.
For this program, CAR-Treg cells are designed to target HLA A2, a common mismatch antigen in transplantation. TxCell is currently evaluating two CAR-Treg cell populations in preclinical models of graft rejection: CD4+FoxP3+ CAR-Treg cells and CD8+FoxP3+ CAR-Treg cells. One HLA A2 CD4+FoxP3+ CAR Treg candidate has already shown strong efficacy in a preclinical GvHD model4,5.
- Zero rate loan reimbursable over 5 years with a grace period of 32 months.
- Gondos A, Döhler B, Brenner H, Opelz G. Kidney graft survival in Europe and the United States: strikingly different long-term outcomes. Transplantation. 2013 Jan 27;95(2):267-74.
- Hartert M, Senbaklavaci O, Gohrbandt B, Fischer BM, Buhl R, Vahl CF. Lung transplantation: a treatment option in end-stage lung disease. Dtsch Arztebl Int 2014; 111(7): 107–16.
- MacDonald KG, Hoeppli RE, Huang Q, Gillies J, Luciani DS, Orban PC, Broady R, Levings MK. Alloantigen-specific regulatory T cells generated with a chimeric antigen receptor. J Clin Invest. 2016, 126(4):1413-1424.
- Levings M. Alloantigen-specific regulatory T-cells generated with a chimeric antigen receptor. Oral presentation at the 18th Congress of the European Society for Organ Transplantation (ESOT), September 24-27, 2017, Barcelona, Spain.