TxCell Completes CAR-Treg Manufacturing Process Development and Provides Update to CMO Selection

Regulatory News:

TxCell SA (FR0010127662 – TXCL) (Paris:TXCL), a developer of cellular immunotherapies based on regulatory T cells (Tregs) for inflammation, autoimmunity and transplantation, today announces 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). TxCell will present additional details on this manufacturing process at the CAR-TCR Summit Europe to be held on February 20-22, 2018, in London, United Kingdom.

TxCell 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.

"It is very important for TxCell to have completed the production process within the expected time frame for its first clinical candidate, a CAR-Treg product for solid organ transplantation. This will enable us to evaluate the potential of TxCell’s platform as soon as possible in a first-in-man study,” said Stephane Boissel, CEO of TxCell. "Our personalized cellular approach could offer an alternative therapy to prevent chronic rejection of transplanted organs. There is a significant risk of post-transplant organ rejection. In lung transplants, for example, this results in a mortality rate of 40% to 55% five years after surgery. As a result, there remains a significant medical need for a novel therapeutic approach.”

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).

About TxCell’s HLA-A2 CAR-Treg

The HLA-A2 CAR-Treg is TxCell’s most advanced CAR-Treg product-candidate. It is based on a subset of CD4+FoxP3+ Tregs. It targets HLA-A2, a common mismatch antigen in transplantation, and is in development for the prevention of chronic rejection after organ transplantation. HLA-A2 CAR-Treg has shown strong efficacy in a preclinical GvHD model^1,2 and is now on track to start a first-in-man study in transplanted patients.

In June 2017, TxCell appointed Lentigen Technology, Inc. (LTI) as its contract manufacturing organization (CMO) for the GMP production of the product’s lentiviral vector.

About TxCell – www.txcell.com

TxCell is a biotechnology company that develops platforms for innovative, personalized T cell immunotherapies for the treatment of severe inflammatory and autoimmune diseases with high unmet medical need. TxCell is targeting transplant rejection as well as a range of autoimmune diseases (both T-cell and B-cell-mediated), including multiple sclerosis, lupus nephritis and bullous pemphigoid.

TxCell’s cellular immunotherapies are based on regulatory T lymphocytes (Tregs). Tregs are a T cell population discovered in the nineties for which anti-inflammatory properties have been demonstrated. Contrary to conventional approaches based on non-specific polyclonal Tregs, TxCell is exclusively developing engineered antigen-specific Tregs, where the antigen specificity is brought by a Chimeric Antigen Receptor (CAR) (CAR-Treg cells).

Based in Sophia-Antipolis, France, TxCell is listed on Euronext Paris and currently has 46 employees.

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Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of TxCell, which shall not be considered per se as historical facts, including TxCell’s ability to develop, market, commercialize and achieve market acceptance for specific products, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements, needs for additional financing. In addition, even if the actual results or development of TxCell are consistent with the forward-looking statements contained in this press release, those results or developments of TxCell may not be indicative of their in the future.

In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. Although the management of TxCell believes that these forward-looking statements are reasonably made, they are based largely on the current expectations of TxCell as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of TxCell could be affected by, among other things, uncertainties involved in the development of the Company’s products, which may not succeed, or in the delivery of TxCell’s products marketing authorizations by the relevant regulatory authorities and, in general, any factor that could affects TxCell capacity to commercialize the products it develops, as well as, any other risk and uncertainties developed or identified in any public documents filed by TxCell with the AMF, included those listed in chapter 4 "Risk factors” of the 2016 document de référence (registration document) approved by the AMF on April 26, 2017 under number R.17-024. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Notwithstanding the compliance with article 223-1 of the General Regulation of the AMF (the information disclosed must be "accurate, precise and fairly presented”), TxCell is providing the information in these materials as of this press release, and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

¹ 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.
² 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.

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