• Preliminary data from the Phase 1 CYCLE-1 trial are expected during second half 2020

Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced the successful administration of the next-generation, NKG2D-based candidate CYAD-02 to a relapsed/refractory acute myeloid leukemia (r/r AML) patient enrolled in the Phase 1 CYCLE-1 trial.

Dr. Dries Deeren, Head of Clinical Hematology at AZ DeltaHospital Roeselare said, “We are proud to be participating in the CYCLE-1 trial evaluating the novel CAR-T cell therapy, CYAD-02, for the treatment of patients with advanced acute myeloid leukemia. Initial clinical results from Celyad’s AML and MDS program look encouraging. Based on preclinical data, where CYAD-02 has shown a differentiated and more potent profile to the first-generation approach, we’re excited to clinically evaluate the next-generation NKG2D construct in such an extremely challenging patient population.”

Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, added, “Dosing the first patient with CYAD-02 marks another major milestone to systematically advance our pipeline of proprietary autologous product candidates in our relapsed/refractory acute myeloid leukemia program. We look forward to investigating this next-generation approach which combines our NKG2D receptor, shRNA technology and OptimAb manufacturing process. Enrollment in the CYCLE-1 trial will continue over the coming months and we expect to report preliminary data from the study during the second half of 2020.”

Background on CYAD-02

CYAD-02 is an investigational CAR-T therapy that engineers an all-in-one vector approach in patient’s T-cells to express both (i) the NKG2D chimeric antigen receptor (CAR), a receptor expressed on natural killer cells that binds to eight stress-induced ligands expressed on tumor cells, and (ii) short hairpin RNA (shRNA) SMARTvector technology licensed from Horizon Discovery to knockdown the expression of NKG2D ligands MICA and MICB on the CAR-T cells. In preclinical models, shRNA-mediated knockdown of MICA and MICB expression on NKG2D CAR-T cells has shown enhanced in vitro expansion, as well as enhanced in vivo engraftment and persistence, of the CAR-T cells, as compared to first-generation NKG2D-based CAR-T cells.

Background on CYCLE-1 Phase 1 Trial

In November 2019, the Company initiated the Phase 1 CYCLE-1 trial (NCT04167696). The open-label, dose-escalation trial will evaluate the safety and clinical activity of a single infusion of CYAD-02 produced with the OptimAb manufacturing process following preconditioning chemotherapy cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), or CyFlu, in patients with r/r AML and myelodysplastic syndromes (MDS). In addition, patients are also eligible to receive bridging therapy, based on physician’s choice, in advance of treatment with CYAD-02. The trial will evaluate three dose levels of CYAD-02, at 100 million, 300 million and one billion cells per infusion.

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