Grote Ogen schreef op 6 december 2019 11:41:
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 therapies, today announced that three abstracts related to the company’s autologous NKG2D-based CAR-T candidates for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndromes (MDS) have been accepted for presentation at the 61st Amercican Society of Hematology (ASH) Annual Meeting, which will be held from December 7-10, 2019, in Orlando, Florida. In addition, management will host a live event at ASH for analysts and investors on Monday, December 9, to review the data from the three posters, as well as updates to the company’s development program for r/r AML and MDS and proprietary OptimAb manufacturing process.
Filippo Petti, chief executive officer of Celyad, noted, “We look forward to providing an update at next month’s ASH Annual Meeting on our autologous CAR-T program focused on the treatment of acute myeloid leukemia and myelodysplastic syndromes, including the latest clinical results from the CYAD-01 Phase 1 THINK and DEPLETHINK trials. In addition, we are excited to highlight the latest preclinical data from our next-generation NKG2D-based candidate CYAD-02 and our OptimAb manufacturing process, which underpins both autologous CAR-T assets within the program.”
ASH Investor/Analyst Event and Webcast Information
Celyad will host an event at ASH for investors and analysts on Monday, December 9, 2019,
beginning at 8:30 p.m. ET to review data presented, as well as to provide updates on the company’s development program for r/r AML and MDS and its proprietary OptimAb manufacturing process. The event will also be webcast live and can be accessed under Events & Webcasts in the Investors section of the company’s website.
Poster Presentation Details:
The following abstracts published today are now available on the ASH websitewww.hematology.org. Following presentation at the meeting, the posters will be available in the library section of Celyad’s website.
Publication #3826: Results from the Completed Dose-Escalation of the Hematological Arm of the Phase I Think Study Evaluating Multiple Infusions of NKG2D-Based CAR T-Cells as Standalone Therapy in Relapse/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome Patients
Date & Time:
Monday, December 9, 2019, 6 p.m. – 8 p.m. ET Publication #3844: Interim Results from the Phase I Deplethink Trial Evaluating the Infusion of a NKG2D CAR T-Cell Therapy Post a Non-Myeloablative Conditioning in Relapse or Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome Patients
Date & Time:
Monday, December 9, 2019, 6 p.m. – 8 p.m. ET Publication #3931: Next Generation NKG2D-based CAR T-cells (CYAD-02): Co-expression of a Single shRNA Targeting MICA and MICB Improves Cell Persistence and Anti-Tumor Efficacy in vivo
Date & Time:
Monday, December 9, 2019, 6 p.m. – 8 p.m. ET Background on THINK Phase 1 Trial
The THINK trial (NCT03018405) is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of multiple CYAD-01 administrations without prior preconditioning. The dose escalation segment of the trial evaluated three dose levels (300 million, 1 billion and 3 billion cells per infusion) of one cycle of three CYAD-01 administrations with two-week intervals. In 2018, the THINK trial was amended to add two cohorts to assess a more frequent dosing schedule of CYAD-01 for the treatment of r/r AML. The cohorts will evaluate six injections of CYAD-01 without preconditioning over two months of administration. The first cycle includes three infusions of CYAD-01 separated by one-week intervals. The second cycle includes three infusions of CYAD-01 separated by two-week intervals. Patients will either receive 1 billion cells per infusion (Cohort 10) or 3 billion cells per infusion (Cohort 11). The primary endpoint of the trial is safety and secondary endpoints include clinical activity and pharmacokinetics.
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 following treatment with the standard preconditioning regimen of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), or CyFlu. The trial includes two different intervals between lymphodepletion and administration of CYAD-01. In addition, 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.
Background on OptimAb Manufacturing Process
Celyad’s proprietary 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 NKG2D-based CAR-T cell therapies produced using the OptimAb manufacturing process drive improved anti-tumor activity in an aggressive AML model compared to alternative manufacturing process.