VALBONNE, France--(BUSINESS WIRE)--Regulatory News:
TxCell SA (Paris:TXCL) (FR0010127662 – TXCL), a developer of cellular immunotherapies based on regulatory T cells (Tregs) for inflammation, autoimmunity and transplantation, today announces it has exercised its exclusive option to in-license the intellectual property rights of one of its academic partners, the University of British Columbia (UBC), onto the HLA-A2 CAR-Treg program.
This program, named TX200 in TxCell's portfolio, should soon be tested in human in the prevention of chronic transplant rejection. A first clinical trial application ("CTA") is expected to be actioned in Europe in the first part of 2019.
The product originated in the laboratories of Dr. Megan Levings, UBC in Vancouver, Canada, who established the first preclinical proof of concept with human HLA-A2-specific CAR-Treg cells in a preclinical model of GvHD1.
TxCell and UBC have been jointly developing this specific program from October 2016 (press release dated October 19, 2016). As licensee, TxCell will have the exclusive rights to develop and later commercialize TX200. Terms and conditions of the license were not disclosed.
“TxCell has made considerable progress with UBC on the development of TX200 since the first agreement was signed in 2016. Thanks to the dedication of both partners, in just 18 months we have moved from an initial proof-of-concept laboratory construct to a proprietary clinical-ready candidate. As a result, TxCell is eager to test this program in human as soon as possible,” said Stéphane Boissel, CEO, TxCell. “There is a significant unmet medical need in the prevention of chronic rejection of solid organs post-transplantation. This is partly because there have been to date no other significant medical advances since the current standards of care were developed more than 20 years ago. These standards currently leave transplanted patients with lifelong therapies, often poorly tolerated and which impose a significant burden to patients’ quality of life without guaranteed tolerance to the graft in the long term. Rates of chronic rejection 10 years after transplantation are high across all organs.”
About Organ Transplantation
Solid Organ Transplantation (SOT) consists in moving an organ (graft) from one body (donor) to another body (recipient or host), to replace the recipient's damaged or absent organ. More than 30,000 organ transplants were performed in the US in 20152, and more than 31,000 in Europe in 20133. Transplant rejection is one of the key challenges of transplantation. In order to avoid such rejection, the most appropriate donor-recipient match is sought and immunosuppressant drugs can be used. In 2014, the global market for immunosuppressant drugs used in transplantation was estimated to reach $5.1 billion4. In the US alone, the cost of long term oral maintenance immunosuppression and other prescription drugs represents between $10,000 and $14,000 per patient per year on average, and can exceed $2,500 per month for certain patients5. Cost of a renal transplantation is itself estimated to amount to $260,0006. New strategies aiming at inducing or restoring immune tolerance to a graft are expected to be less toxic and more efficient on the long-term than classical pharmacological immunosuppressive approaches. Beyond improving patients’ health, preventing chronic rejection of transplanted organs is a major challenge for payers.
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 transplantation as well as a range of autoimmune diseases (both T-cell and B-cell-mediated), such as multiple sclerosis, rheumatoid arthritis, inflammatory bowel diseases or inflammatory skin diseases.
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.
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 2017 document de référence (registration document) submitted to the AMF on April 25, 2018. 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 US Department of Health & Human
Services. ‘More than 30,000 transplants performed annually for first
time in United States’ January 9, 2016.
3 European
Commission, Journalist workshop on organ donation and transplantation,
November 26, 2014.
4 Organ Transplant Immunosuppressant
Drugs Market, Transparency Market Research 2015.
5 James
A, Mannon RB. The Cost of Transplant Immunosuppressant Therapy: Is This
Sustainable? Curr. Transplant. Rep. 2015, 2(2):113-121.
6
Bentley TS, Hanson SG. 2011 US Organ and tissue transplant cost
estimates and discussion. Brookfield, WI: 2011.
