XNK Therapeutics collaborated with Karolinska Institutet for initiating Phase 2 study in patients with multiple myeloma with XNK Therapeutics’ lead product CellProtect in combination with Sanofi’s anti-CD38 antibody Sarclisa
This is an investigator-initiated Phase 2 trial where XNK will provide its novel autologous NK cell-based product CellProtect while the study is to take place at the Karolinska University Hospital in Stockholm, Sweden and Sanofi’s support by providing Sarclisa
“Performing this Phase 2 study together with Karolinska Institutet is an important step for XNK in its ambition to combat multiple myeloma,” said Johan Liwing, CEO of XNK Therapeutics. “Combining our efforts together with the present partners highlights just how far XNK has progressed with its patented technology platform.”
Trial details: ISA-HC-NK; Phase 2 in multiple myeloma maintenance; N=60; CellProtect 3×107 cells/kg IV + Isatuximab 10 mg/kg IV; Primary outcomes: ORR, MRD negativity rate; PCD: Dec’27; Not yet recruiting; Location: Sweden
Sanofi partnered with XNK for its first NK cell combination with Sarclisa in MM
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CI Scientists Remarks:
About of the company: XNK Therapeutics is focused on novel NK cell-based therapies. XNK’s technology platform was built on the research on NK cells at Karolinska Institutet in Stockholm
About CellProtect: It is an autologous NK cell-based therapy. Its nature allows it to be in combination with other treatments to potentially enhance the clinical effect when used as an adjunct therapy
The product was granted ODD for the treatment of MM in EU and US
FIH study and results: A Phase 1/2 trial was conducted with CellProtect as a consolidation treatment following high dose autologous stem cell transplantation in patients ND with MM at the Hematology Center, Karolinska University Hospital, Stockholm, Sweden
OS: 100% after a median follow-up time of 60 months; mPFS: 34 months
Demonstrated a high degree of safety, and no severe adverse events (SAE)
Patients with measurable disease showed objective measurable responses to NK cell infusion in terms of reduction in M-component and/or MRD
After encouraging FIH Phase 1/2 trial results, XNK is evaluating combination strategy using CellProtect with isatuximab as a consolidation treatment following ASCT in patients with newly diagnosed multiple myeloma