Mont-Saint-Guibert, Belgium – Cardio3 BioSciences (C3BS) (Euronext Brussels and Paris: CARD), a leader in engineered cell-therapy treatments with clinical programs initially targeting indications in cardiovascular disease and oncology, today announced the enrollment of the first patient in a Phase I clinical trial evaluating the Company’s lead CAR T-Cell therapy, NKG2D CAR T-Cell, in blood cancer patients with acute myeloid leukemia (AML) or multiple myeloma (MM). Cell engineering and processing will be followed in the coming days by the infusion of NKG2D CAR T-Cells into the patients.
NKG2D CAR T-Cell is an autologous chimeric antigen receptor T lymphocyte (CAR T-cell) therapy constructed using the native sequence of non-engineered natural killer cell (NK cell) receptors which, unlike traditional CAR technologies such as those targeting the CD19 antigen, have the potential to target a broad range of solid tumors and blood cancers by targeting ligands present on numerous cancer types. We believe that NKG2D CAR T-Cell is a potential new treatment option for patients with solid tumors such as breast, colorectal, lung, liver, ovarian and bladder cancer, in addition to the blood cancers targeted in this trial. The research underlying this technology was originally conducted at Dartmouth College by Professor Charles Sentman, and has been published in numerous peer-reviewed publications such as Journal of Immunology, Cancer Research and Blood.
NKG2D CAR T-Cell received an Investigational New Drug (IND) clearance, under the name CM-CS1, from the U.S. Food and Drug Administration (FDA) in July 2014 for the Phase I clinical trial in hematologic cancers.
Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented: “We are extremely pleased to initiate enrollment of the first Phase I trial of our CAR T-Cell therapy program with lead product candidate NKG2D CAR T-Cell, in-line with our previously disclosed clinical development plan. As AML and MM are two underserved blood cancer subtypes, there is a clear need for new, viable treatment options. To date, NKG2D CAR T-Cell therapies have demonstrated the prevention of tumor development and increased survival in preclinical animal models, suggesting that NKG2D CAR T-Cell has the potential to be one such therapy.”
This trial is assessing the safety and feasibility of NKG2D CAR T-Cell as primary endpoints, with secondary endpoints including clinical efficacy. Cardio3 BioSciences expects to complete the study in mid-2016 and will provide updates as the trial advances.