Evencaleucel – Multiple Myeloma
XNK’s lead product evencaleucel is currently being evaluated in a randomized, controlled, phase II study in combination with the CD38 mAb, isatuximab, in collaboration with Sanofi and the Karolinska Institute. The study compares evencaleucel combined with isatuximab with isatuximab alone as consolidation therapy following autologous stem cell transplantation in patients with newly diagnosed multiple myeloma – the third most frequent hematological malignancy worldwide. For more information about the study see NCT04558931.
Evencaleucel is well suited to be combined with a CD38 antibody as XNK’s expansion and activation platform down-regulates CD38 expression in the NK cells. This limits the ability of the antibody to target the NK cells and thus enables the full potential of the synergistic effect expected from the antibody-dependent cellular cytotoxicity (ADCC) mechanism to kill malignant cells.
A phase I study has been successfully concluded with excellent safety and tolerability results. The study was published in Cell Reports Medicine in February 2022.
Evencaleucel has been granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma by the US Food and Drug Administration (FDA) as well as by the European Medicines Agency (EMA) in the EU.
Evencaleucel is also being investigated for treatment of smoldering multiple myeloma and multiple myeloma in the elderly.
XNK02 – Acute Myeloid Leukemia (AML)
The autologous NK cell-based product XNK02 is being investigated for the treatment of acute myeloid leukemia (AML). In preparation for clinical studies, preclinical proof-of-concept studies using AML patient material from various stages of the disease, are underway in collaboration with University of Texas MD Anderson Cancer Center. The goal is to establish patient selection criteria for a clinical trial using XNK’s platform and to develop novel therapeutic approaches for AML patients.
XNK03 – Urothelial Cancer
The autologous NK cell-based product XNK03 is being investigated for the treatment of urothelial cancer, the most common form of bladder cancer. According to the American Cancer Society more than 80,000 new cases of bladder cancer are expected in the US in 2022 alone.
In collaboration with the Karolinska University Hospital, the feasibility of XNK03 is currently being tested based on material from patients with locally advanced or metastatic urothelial cancer with the goal of taking this further into a clinical trial.
Please see Q&A about the XNK03 study with Dr. Anders Ullén at the Karolinska University Hospital.