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Celyad presents update on CYAD-01 solid tumor clinical program.

Celyad announced updated clinical results for the CYAD-01 program in solid tumors as well as translational research data presented at the Society for Immunotherapy of Cancer, or SITC, 33rd Annual Meeting. In the THINK Phase 1 dose-escalation trial, 14 patients with relapsed/refractory disease were enrolled in the trial, evaluating CYAD-01 without preconditioning chemotherapy at three different dose levels of one cycle of three administrations with two-week intervals. Overall four patients experienced confirmed disease stabilization, three mCRC patients and one patient with ovarian cancer, according to RECIST 1.1 criteria. As a monotherapy treatment, CYAD-01 was well tolerated. The peak level of peripheral CYAD-01 cells detected seem to correlate with the dose level and clinical response. In the SHRINK Phase 1 open-label, dose-escalation trial, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks 48 hours after the end of chemotherapy at cycles two, three and four. To date, enrollment of dose level one has been completed with three metastatic treatment-naive patients. All patients have undergone resection without delays in surgery. Initial activity results assessed by pathological response criteria showed all three patients achieved an objective clinical response, including one patient with a pCR and two patients with pPR. Concurrent treatment of CYAD-01 with FOLFOX chemotherapy appears to be well tolerated, with no occurrence of serious AEs nor increase of treatment-related AEs rate. In addition, the expansion of peripheral CYAD-01 cells with a concurrent administration of FOLFOX chemotherapy is similar to the one observed with the standalone CYAD-01. Full data from the SHRINK Phase 1 trial are expected in mid-2019. Frederic Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented, "Solid tumors remain the greatest current challenge for any T cell therapy. One of the major hurdles is the lack of suitable targets, and in our perspective, NKG2D ligands that are targeted by CYAD-01 represent an attractive family of targets on solid tumors that may be exploited by our clinical candidates. I am encouraged that to date CYAD-01 is well tolerated as a monotherapy for the treatment of mCRC, while preliminary observations of clinical activity in the form of disease stabilization imply that there is potential for the approach. Furthermore, the initial findings of clinical activity reported from the initial dose level of CYAD-01 when administered concurrently with standard-of-care chemotherapy in the SHRINK trial are encouraging and provide support for this view."

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Publication:The Fly
Date:Nov 9, 2018
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