Transformation to CAR-Treg platform successfully achieved and validated by preliminary preclinical results
Conference call in English on Friday, September 22 at 11:30am CEST
Valbonne, France, September 21, 2017, 5:45pm CEST
TxCell SA (FR0010127662 – TXCL), a developer of cellular immunotherapies based on regulatory T cells (Tregs) for inflammation, autoimmunity and transplantation, today announces its consolidated financial results for the first half of 2017 and provides an update on its strategy and outlook.
The TxCell Half Year Financial Report as of June 30, 2017 is available on the company’s website www.txcell.com in the Investors / Documentation / AMF regulated information section.
HLA-A2 CAR-Treg program on track to start first-in-man study in transplanted patients
TxCell’s most advanced CAR Treg product-candidate, which targets the prevention of chronic rejection after organ transplantation, is on track to start a first-in-man study by the end of 2018. Start of clinical development will be subject to availability of appropriate funding.
In June 2017, TxCell achieved a critical step in the development of this product candidate by appointing Lentigen Technology, Inc. (LTI) as its contract manufacturing organization (CMO) for the GMP production of the product’s lentiviral vector. Finalization of the CAR-Treg manufacturing process is ongoing and TxCell is in the process of selecting a second CMO for GMP production of the cellular therapy drug product per se. Such selection should be done before year end 2017.
Recently, TxCell and its academic partner, UBC, obtained a new preclinical proof-of-concept in a GvHD model with a humanized clinical candidate. This humanized candidate showed similar efficacy results to those previously published with the original murine construct. This is in addition to an improved safety profile. Detailed data will be presented by Prof. Megan Levings during the 18th Congress of the European Society for Organ Transplantation (ESOT) to be held in Barcelona, Spain on September 24-27, 2017. TxCell will provide more details on results the day of the oral presentation.
Promising results obtained with other CAR-Treg programs
Ongoing in vitro and in vivo studies conducted by TxCell are showing promising preliminary results in relevant models of autoimmune diseases, including multiple sclerosis, confirming TxCell’s CAR-Treg platform strategy. In the next few months, TxCell will present new proof-of- concept data in clinically relevant mouse models with several candidates at appropriate scientific conferences and/or in peer-reviewed journals.
TxCell intends to focus on its 4 to 5 most promising preclinical programs. As a result, the Company may discontinue certain discovery programs and/or academic collaborations.
Update on ASTrIA
TxCell has fully completed the optimization of the ASTrIA manufacturing process. As expected, the reduction of production costs and of the overall manufacturing leadtime allowed by the new process identified by TxCell in 2016 can reach 50%. The new ASTrIA process is simple, robust and scalable. However, TxCell now intends to lower its investment on the ASTrIA platform and to focus on continuing promising developments on the ENTrIA platform. This includes utilizing know-how and intellectual property from the ASTrIA platform to work on new engineered Tregs. As a result, the ASTrIA and ENTrIA denominations will ultimately be replaced by a single platform of engineered Treg products.
“After making important progress with our CAR-Treg programs, we can now confirm that we have successfully achieved the conclusion of TxCell’s transformation to a platform of engineered regulatory T cells,” said Stéphane Boissel, CEO of TxCell. “Our unique CAR-Treg technology positions TxCell as a pioneer at the crossroad between two vibrant industry segments – the CAR-T space and the Treg space. The CAR-T space only this month provided a $12 billion acquisition and a revolutionary first FDA approval. In the Treg space, five strategic Treg business deals have been signed by pharma/biotech companies in less than a year. Therefore, we remain confident in the future prospects of our technology.”
“TxCell’s H1 figures are in line with our expectations regarding operating costs and cash burn. We continue to carefully monitor all costs,” said Raphaël Flipo, CFO of TxCell. “The warrants which were attached to new shares as part of the February 2017 financing have passed halfway through their maturity. If all the warrants are exercised, the proceeds would finance TxCell’s activities through to the IND approval for the first CAR-Treg clinical study, which is expected by the end of 2018. We are also looking at alternative financing options should these warrants not be fully exercised at maturity. We will continue to keep the market informed in due time regarding these options.”
Please download the full press release in PDF to view the financial highlights for the first half of 2017.