Previous studies revealed that long-term ex vivo expansion and activation of autologous NK cells from Multiple myeloma patients provides significantly superior cytotoxic activity against autologous tumor cells when compared to short-term activated autologous NK cells (Alici, Sutlu et al. 2008). Furthermore, efficient NK cell-based treatment of Multiple myeloma development in an animal model has been reported (Alici, Konstantinidis et al. 2007). Having optimized the procedure for NK cell expansion in a closed-automated bioreactor using clinical grade GMP-compliant components, all the preclinical requirements were in place to get approval from the Swedish Medical Products Agency (EudraCT: 2010-022330-83) and the ethical committees (EPN: 2013/490-32) to initiate a first-in-human phase I/II clinical trial ACP-001 (Sutlu, Stellan et al. 2010, Sutlu and Alici 2011). The expanded cells are fully compliant with the EU ATMP Directive.
XNK Therapeutics’ technology platform is built on the world’s leading research on NK cells at Karolinska Institutet in Stockholm. Multiple myeloma is the leading indication for CellProtect.