Safety follow-up completed for third dose level of NKR-2 trial

Celyad has completed the 21-day safety follow-up of the last patient enrolled in the third dose level cohort in its Phase I/IIa clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy using T-cells with NKG2D receptor in acute myeloid leukaemia and multiple myeloma. No safety issues were reported.

Dr Christian Homsy, CEO of Celyad, commented: “The study is progressing as planned, with the third dose level successfully completed and the upcoming initiation of the fourth dose level cohort, and no adverse safety signals observed so far for the 9 treated patients. We are now preparing the next dose levels and look forward to the data that are expected in the next few months.”

Dr Frédéric Lehmann, Head of Immuno-Oncology at Celyad, added:“We are pleased that no adverse safety signal has been reported for the patients of the third dose of this first-in-human Phase I/IIa study. This technology has great potential in multiple cancer indications and we look forward to completing this Phase I/IIa and moving to the next stage of our clinical development. I am grateful to our principal investigator who has positioned us so well to complete the fourth dose by mid-2016.”

Full data readout from Phase I dose escalation trial expected mid-2016

Existing CAR-T cells are engineered using constructs encoding an antibody single chain variable fragment, the signaling domain of CD3 zeta and one or more co-stimulatory domain. In contrast to existing CAR-T cells, Celyad’s lead immuno-oncology product candidate, NKR-2, is a T-Cell encoded to express the human Natural Killer activating receptor, NKG2D. Using the human Natural Killer cell receptor, unlike traditional CAR technologies, has the potential to:

• Bind to 8 different ligands that are expressed by a vast majority of cancer cells, both haematological and solid malignancies;
• Target and kill tumours as well as the blood vessels that feed them and also express the ligands of the NKG2D receptor;
• Target and kill the inhibitory mechanisms preventing the tumour from evading the immune system;
• Induces adaptive auto-immune response thanks to the creation of a long term cell memory against the targeted tumour;

NKR-2 has an active Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a Phase I clinical trial. The full data readout from the Phase I dose escalation trial is expected in mid-2016. The trial is designed to assess the safety and feasibility of NKR-2 in acute myeloid leukaemia and multiple myeloma patients, with secondary endpoints including clinical activity. The safety follow-up period post-infusion has been decreased to 21 days after approval by the FDA and Institutional Review Board (IRB). 

You can read more about Celyad’s NKR-2 t-cell therapy in an exclusive article from Dr Lehmann here.