- The trial is a dose escalation study evaluating safety and feasibility of NKR-2 T-cell therapy in patients with Acute Myeloid Leukemia or Multiple Myeloma.
- No dose limiting toxicity reported in the last patient of the third dose level.
- Process to enroll the first patient of fourth dose cohort has commenced.
Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, with clinical programs in cardiovascular disease and immuno-oncology, today announced the completion of 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 Leukemia and Multiple Myeloma patients. No safety issues were reported.
Dr. Christian Homsy, CEO of Celyad: “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:“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.”
About Celyad’s NKR-T program
NKR stands for Natural Killer Receptor. NKG2D CAR T-cells are now called NKR-2 T-cells and the product development name is NKR-2.
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(s). 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 hemaetological and solid malignancies.
- Target and kill tumors 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 tumor from evading the immune system.
- Induces adaptive auto-immune response thanks to the creation of a long term cell memory against the targeted tumor.
The research underlying this technology was originally conducted by Dartmouth College Professor Charles Sentman, and has been published in numerous peer-reviewed publications. NKR-2 has an active Investigational New Drug (IND) application with the 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 leukemia 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 U.S. Food and Drug Administration (FDA) and Institutional Review Board (IRB).