The company owns assets related to the investigational drug product and manufacturing technology. The manufacturing process of CellProtect encompasses a unique closed system for the development of the autologous NK cell-based investigational drug product.
The process includes a selective expansion and activation of NK cells from peripheral blood of patients with cancer. The product is produced in less than three weeks. The NK cell product is delivered to the clinic upon need, where the product is thawed and infused to the patient without any further processing. The product has demonstrated an up to 10-year stability in liquid nitrogen. The assets of XNK Therapeutics are protected by patents in the US, Europe, and certain other jurisdictions. Additional patent applications have been filed. The patented technology and investigational drug product have been tested in a first-in-human Phase I/II clinical trial
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.
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.