Celyad SA (NASDAQ:CYAD) has reached the potentially crucial three billion natural killer receptor (NKR) CAR T-cell dose (CYAD-01) in acute myeloid leukaemia (AML) with the first patient showing no signs of toxicity. If responses are seen in several patients, an expansion phase could start; a strong response was seen in November at the 300 million cell dose. Interim data are promised by Celyad in late 2018, probably at ASH. There are now several studies running or starting including using two courses of CYAD-01 in AML (after an initial response), evaluation of conditioning therapy with AML and combinations of CYAD-01 with chemotherapy in colorectal cancer. The indicative value remains at €1,040m, €84 per share.
A sophisticated clinical program in AML
In 2017, an AML patient given three doses of 3x108 NKR CAR T-cells (CYAD-01) over 28 days had a near complete response; the case report has been published. This encouraging response with strong blood cell recovery levels and reduction in cancer cells (blasts) is being developed in three ways. First, the planned 3x109 CYAD-01 dose is now being tested in the THINK study and this may enable a trial expansion to assess efficacy. Second, multiple CYAD-01 28-day courses are being tested, initially at the 1x109 dose when a patient shows an initial response; this indicates that responses are being seen. A second course may enhance overall responses as no preconditioning is used in THINK so no cell expansion is seen. Third, the DEPLETHINK study will test a non-myeloablative preconditioning regimen plus CYAD-01 in AML /MDS patients to test for CYAD-01 expansion.
To read the entire report Please click on the pdf File Below: