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Celyad Oncology announces the publication of data from its Phase 1 THINK study of CYAD-01

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Mont-Saint-Guibert, Belgium – Celyad Oncology (Euronext & Nasdaq: CYAD) (the “Company”), a biotechnology company focused on the discovery and development of innovative technologies for chimeric antigen receptor (CAR) T-cell therapies, today announces the publication of the data from the haematological arm of the THINK study which evaluated CYAD-01 in relapsed or refractory (r/r) acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) or multiple myeloma (MM) patients. The findings were published in the journal The Lancet Haematology.

CYAD-01 is the Company’s first autologous CAR T-cell candidate, based on the natural killer receptor NKG2D, assessed clinically. The completed THINK study was an open-label, dose-escalation Phase 1 study for patients with r/r AML, MDS, or MM, after at least one previous line of therapy. Patients were recruited from five hospitals in the USA and Belgium.

The Lancet Haematology publication includes data from the 16 patients treated with CYAD-01 in the dose escalation segment of the study, which evaluated three dose levels of CYAD-01 using a schedule of three infusions at two-week intervals in the absence of any preconditioning chemotherapy. Overall, CYAD-01 showed favourable safety data with signs of clinical activity with three of the 12 evaluable AML/MDS patients presenting an objective response.

Importantly, the THINK study is one of the first completed dose-escalation CAR T-cell studies in r/r AML/MDS. Unlike the majority of the studies evaluating CAR T-cell therapy candidates, the THINK study evaluated multiple infusions of CYAD-01 as a stand-alone product candidate (i.e., without prior bridging or preconditioning chemotherapy). This feature is of particular interest considering the median older age and the poorer general condition of patients with r/r AML or MDS at diagnosis.

Although the need to improve the anti-tumour activity is warranted, these data in a difficult-to-treat patient population potentially provide the proof-of-concept of targeting NKG2D ligands by a CAR T-cell product candidate, and support the further development of NKG2D-based CAR T-cell therapies.

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Celyad Oncology Announces FDA Clearance of IND Application for CYAD-211, First shRNA-based, Non-Gene Edited Allogeneic CAR T Therapy

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  • Phase 1 clinical trial evaluating the off-the-shelf anti-BCMA CAR T candidate CYAD-211 for the treatment of relapsed/refractory multiple myeloma (r/r MM) expected to begin by year-end 2020
  • CYAD-211 represents the company’s first allogeneic CAR T clinical candidate using shRNA technology

Mont-Saint-Guibert, Belgium – Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, today announced that  the company’s Investigational New Drug (IND) application for CYAD-211, the company’s first-in-class short hairpin RNA (shRNA)-based allogeneic CAR T candidate and second non-gene edited off-the-shelf program, is in effect with the U.S. Food and Drug Administration (FDA). The company’s lead allogeneic candidate from its next-generation CYAD-200 series, CYAD-211 targets B-cell maturation antigen (BCMA) for the treatment of relapsed / refractory multiple myeloma (r/r MM). CYAD-211 is engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3ζ component of the T-cell receptor (TCR) complex.

“The FDA’s permission to begin the Phase 1 clinical trial of our lead shRNA-based allogeneic candidate CYAD-211 is a watershed moment for our organization,” commented Filippo Petti, Chief Executive Officer of Celyad Oncology. “Today’s announcement demonstrates our ability to advance in parallel multiple off-the-shelf product candidates based on differentiated non-gene edited allogeneic technologies into the clinic. In addition, our team has delivered on incredible timelines for the CYAD-211 program, moving the project from concept to an effective IND in under two years. We are excited to have the CYAD-211 IND in effect to initiate the Phase 1 trial by year-end 2020 for this first-in-class CAR T candidate for patients with multiple myeloma and look forward to accelerating the development of additional shRNA-based allogeneic candidates from our CYAD-200 series towards clinical trials.”

Celyad Oncology’s shRNA-based Platform for Allogeneic CAR T

Celyad Oncology is advancing a pipeline of proprietary, non-gene edited allogeneic CAR T candidates from its CYAD-200 series, which is underpinned by its shRNA technology platform. The shRNA platform coupled with the company’s all-in-one vector approach provides flexibility, versatility, and efficiency to the design of novel, off-the-shelf CAR T candidates through a single step engineering process. Next-generation candidates exploring the breadth and depth of the Celyad Oncology shRNA platform are currently under preclinical development. Combining shRNA knockdown with additional functional components in a single CAR T construct may also offer therapeutic optionality to the non-gene edited allogeneic CYAD-200 series of product candidates. In 2018, Celyad Oncology signed an exclusive agreement with Horizon Discovery Group for the use of its SMARTvector shRNA technology for the development of allogeneic CAR T therapies.