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£1M awarded to replace animal studies and improve the safety assessment of cell therapies

24 January 2024

A team led by Professor Toni Cathomen at the University of Freiburg (Germany) has secured £1M of CRACK IT Challenge funding to develop an approach to evaluate the tumourigenicity of human engineered T cell therapies. 

This funding continues the NC3Rs commitment to the development of 3Rs approaches and technologies in the evolving field of cell and gene therapy, which has reached a total investment through the CRACK IT Challenges programme of £4.8M. Cell and gene therapies offer huge potential in the treatment of previously incurable conditions through using genetically engineered cells that can target diseased tissue. 

“The approach developed through the T-ALERT Challenge has the potential to significantly improve the tumourigenicity assessment of CAR-T cell therapies without using animals. We are looking forward to working with Professor Cathomen and his team, the Sponsors and HESI to address this important Challenge within the cell and gene therapy landscape.”

Dr Kate Harris, NC3Rs CRACK IT Challenges Programme Manager.

Chimeric antigen receptor (CAR-T) cell therapy uses T cells that have been genetically engineered to express CARs on their cell surface to target and destroy cancer cells or to treat auto-immune and inflammatory disorders. A key safety concern associated with the genetic modification of T cells is the potential for the cells to transform and become tumouriogenic. Preclinical in vivo studies in mice to assess the tumourigenic potential of CAR-T cells are invasive, require long study durations and are often not predictive of clinical outcome. Developing improved assays to reliably assess the tumourigenicity of CAR-T cell therapies has the potential to replace in vivo studies. 

Collaborating with five industry Sponsors and supported by the Health and Environmental Sciences Institute (HESI), the team led by Professor Toni Cathomen will develop a classifier, a tool which uses machine learning (ML) to identify a combination of predictors of tumourigenicity in genetically modified in vitro cultured CAR-T cells. The team has already demonstrated proof-of-concept for in vitro T cell immortalisation, a prerequisite to developing the ML-based classifier. 

 “As a team, we are thrilled to have been awarded £1M in CRACK IT Challenge funding. With the support of our industry sponsors, we are pioneering a machine learning-driven approach that not only has the potential to replace animal testing, but also promises to revolutionise the safety assessment of CAR-T cell therapies.”

Prof Toni Cathomen, Uni of Freiburg.

“HESI’s Cell Therapy - TRacking, Circulation and Safety (CT-TRACS) Technical Committee congratulate the University of Freiburg on the award. As a Challenge Partner, we look forward to leveraging the committee’s network of organisations and subject matter experts who are focused on tumourigenicity evaluations of cell therapy products to further support the development of this new approach.”

Dr Connie L. Chen, HESI

Visit the T-ALERT Challenge page for further information about this Challenge.