No Treatment-Related Safety Concerns Reported
  • No safety issues related to the investigational treatment reported at 30 days post treatment of the first patient following single dose NKG2D CAR T-cell infusion; triggers enrollment of other two patients in the first cohort.
  • The trial is a dose escalation study evaluating safety and feasibility of a CAR T-cell therapy in patients with acute myeloid leukemia or multiple myeloma.

MONT-SAINT-GUIBERT, Belgium I June 10, 2015 I Celyad SA (Euronext Brussels and Paris: CYAD), today announced the completion of the 30-day safety follow-up of the first patient enrolled in the Company’s Phase I clinical trial evaluating the safety and feasibility of its NKG2D CAR T-cell therapy, in cancer patients suffering from acute myeloid leukemia (AML) or multiple myeloma (MM).

The first patient suffers from AML. This Phase I trial is a dose escalating study. Following the infusion of the first dose of NKG2D CAR T-cell, no safety issues were reported with the treatment over the follow-up period of 30 days. This marks an important step in demonstrating the safety of NKG2D CAR-T cell infusion at that dose and triggers the enrollment of the next two patients in the first dose cohort.

Dr. Christian Homsy, CEO of Celyad, commented, “At 30 days post NKG2D CAR-T cell infusion for this first patient, no safety issues were reported. This is a great milestone in validating our new CAR T-cell platform. We look forward to recruiting of the remaining patients in this first dose cohort.”

The full data readout from the Phase I trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKG2D CAR T-cell as primary endpoints, with secondary endpoints including clinical efficacy.

The NKG2D CAR T-cell is an autologous chimeric antigen receptor T lymphocyte (CAR T-cell) therapy constructed using the native sequence of natural killer cell (NK cell) receptors which, unlike traditional CAR technologies such as those targeting the CD19 antigen, has the potential to target a broad range of solid tumors and blood cancers by targeting ligands present on numerous types of cancer cells. 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.

About Celyad

Founded in 2007, and based in Belgium, Celyad is a leader in engineered cell therapy treatments with clinical programs initially targeting indications in cardiology and oncology. Celyad is developing its lead cardiovascular disease product candidate, C-Cure(R), for the treatment of ischemic heart failure, and has completed enrollment of a Phase III trial in Europe and Israel. In addition, the Company is developing a novel portfolio of CAR T-cell therapies that utilize human Natural Killer cell receptors for the treatment of numerous blood and solid cancers. Its lead oncology product candidate, NKG2D CAR T-cell, entered a Phase I clinical trial in April 2015.

SOURCE: Celyad