Celyad SA (NASDAQ:CYAD) can now move to the highest planned dose of 3x107 cells in the important NKR-2 Phase II CAR trial. If the next 30m cell dose is also safe (and the MTD) it will lead to two separate six patient open label studies in Acute Myeloid Leukaemia and Multiple Myeloma. Further data is possible in late June. Efficacy indications in either of these could enable a series of solid tumour exploratory studies. The advantage of the NKR-T immuno-oncology approach is that it is easily transferred to multiple cancer types. FY15 accounts were as expected with year-end cash of €108m.
CAR progress: high dose cohort can start
Celyad’s emphasis is now on the NKR-T CAR platform with its broad potential in multiple cancer types. The US NKR-2 immuno-oncology Phase I has completed the third dose level and with no safety issues can move to the 30m dose level. It is not certain if this will be the maximum tolerated dose (MTD) expected to be used in later solid tumour studies. Once an MTD is found, the trial will move into an expansion phase where six acute myeloid leukaemia (AML) and six multiple myeloma (MM) patients are recruited in total. Management expects further data by late June. Solid tumour indication studies are being planned at the highest dose level. An allogeneic technology is in preclinical development.
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