On September 4, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported the successful administration of CYAD-01 produced with the OptimAb manufacturing process to a patient enrolled in cohort 3 (300 million cells) of the Phase 1 DEPLETHINK trial (Press release, Celyad, SEP 4, 2019, View Source [SID1234539267]).
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Jean-Pierre Latere, Chief Operating Officer of Celyad said "The dosing of the first patient with CYAD-01 manufactured with the OptimAb process marks another important milestone for our company. The OptimAb manufacturing process has shown exciting activity in preclinical models and we believe that the integration of the manufacturing process into our autologous relapsed/refractory acute myeloid leukemia program should help us to improve upon the initial signals we have observed to date with CYAD-01. We look forward to reporting preliminary data from patients enrolled in the DEPLETHINK trial treated with CYAD-01 produced with the OptimAb process by the end of the year."
Background on CYAD-01
CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells.
Background on OptimAb Manufacturing Process
The OptimAb manufacturing process utilizes a shortened cell culture and incorporates a selective PI3K inhibitor. This results in a product that is enriched for T cells with a memory-like phenotype. Preclinical data demonstrate that CYAD-01 produced using the OptimAb manufacturing process drives improved anti-tumor activity in an aggressive acute myeloid leukemia (AML) model compared to CYAD-01 produced with the previous mAb manufacturing process.
Background on DEPLETHINK Phase 1 Trial
In October 2018, Celyad initiated the DEPLETHINK Phase 1 trial (NCT03466320). The open-label, dose-escalation trial will evaluate a single infusion of CYAD-01 for the treatment of relapsed/refractory AML and myelodysplastic syndromes (MDS) following preconditioning chemotherapy (cyclophosphamide [300 mg/m²] and fludarabine [30 mg/m²]). The trial will evaluate three dose levels of CYAD-01 including 100 million, 300 million and 1 billion cells per infusion, respectively. The primary endpoint of the trial is safety and secondary endpoints include clinical activity and pharmacokinetics.