• Lead candidate CYAD-01 continues to demonstrate encouraging clinical activity in THINK Phase 1 trial with a new complete response (CR) observed in patient with myelodysplastic syndrome (MDS)
  • Key focus to accelerate the development of CYAD-01 for the treatment of patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) or MDS, including the initiation of a Phase 2 clinical trial during second half 2019

 

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 that it is accelerating its clinical development strategy for AML and MDS and provided updates on clinical candidates CYAD-01 and CYAD-101 with key upcoming milestones for 2019.

“We made progress in 2018 with our CAR-T clinical programs and we believe the Company is poised to achieve a number of important milestones in 2019,” noted Dr. Christian Homsy, CEO of Celyad. “We continue to be encouraged by the clinical data observed with CYAD-01 for the treatment of hematological indications. As a result, we are prioritizing the clinical development program of CYAD-01 for the treatment of relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome towards Phase 2 trials.”

2019 Milestones

Building upon its 2018 accomplishments, the Company intends to achieve the following key milestones over the next 12 months:

  • Report additional data from the Phase 1 dose-escalation THINK trial for CYAD-01 in r/r AML or MDS patients, including initial data from the schedule optimization portion of the trial;
  • Complete enrollment for and report initial data from the Phase 1 dose-escalation DEPLETHINK trial evaluating CYAD-01 with preconditioning chemotherapy in r/r AML or MDS patients;
  • Accelerate the development strategy and refine the regulatory pathway plan for CYAD-01 for the treatment of r/r AML or MDS patients, including the initiation of a Phase 2 clinical trial;
  • Present in vivo preclinical data for our proprietary non-gene edited allogeneic shRNA platform and progress towards an Investigational New Drug (IND) application for the program; and
  • Further evaluate the potential for next-generation autologous and allogeneic NKG2D-based CAR-T therapies in the treatment of solid tumors.

Clinical Update for CYAD-01 in Hematological Malignancies

Celyad’s lead clinical candidate, CYAD-01, is currently being evaluated in multiple clinical trials for the treatment of patients with hematological malignancies, including r/r AML and MDS.

THINK Phase 1 Trial

  • In December 2018 at the 60th Annual American Society of Hematology meeting, Celyad reported an encouraging objective response rate in r/r AML patients of 38% (three out of eight) from the THINK Phase 1 trial, evaluating CYAD-01 without preconditioning chemotherapy.
  • Preliminary data for the last two patients enrolled and treated at dose level 3 show one patient with relapsing MDS with refractory anemia with excess blasts achieved a marrow complete response after two injections of CYAD-01, while the second patient with r/r AML experienced disease stabilization after the first cycle of CYAD-01. Both patients plan to receive a second (consolidation) cycle of therapy.
  • Additional results from the THINK Phase 1 trial are expected to be announced during the first half of 2019.

Dr. Frédéric Lehmann, Vice President of Clinical Development and Medical Affairs at Celyad, commented,Current clinical data for the last two patients treated at dose level 3 of the THINK trial provide additional support for the further development of CYAD-01 as a potential treatment of  r/r AML and MDS and our decision to rapidly identify the best clinical path forward for the investigational therapy.”

DEPLETHINK Phase 1 Trial

  • In December 2018, Celyad reported initial data from Cohort 1 of the trial, in which the administration of CYAD-01 following the preconditioning regimen of cyclophosphamide and fludarabine was well-tolerated, with no dose-limiting toxicity or treatment-related grade 3 or above adverse events observed. Based on these preliminary safety data from Cohort 1, enrollment has been initiated in Cohort 2 of the trial. Preliminary data from the DEPLETHINK Phase 1 trial are expected in mid-2019.

EPITHINK Phase 1 Trial

  • Based on the data generated to date for CYAD-01 from the THINK trial and the recent update in the treatment landscape for newly diagnosed AML patients, the Company has put the EPITHINK trial on hold to focus its efforts on the development of CYAD-01 for the treatment of r/r AML patients. Celyad plans to reassess the opportunity for CYAD-01 in newly diagnosed AML patients after the optimal treatment design for the therapy is determined. The EPITHINK Phase 1 dose-escalation trial planned to assess the administration of CYAD-01 concurrently with 5-azacytidine in treatment-naïve and/or elderly AML patients ineligible for intensive treatment.

Solid Tumor Clinical Program Update

  • In November 2018 at the Society for Immunotherapy of Cancer 33rd Annual Meeting, the Company reported an interim analysis from the Phase 1 dose-escalation SHRINK trial evaluating the safety and activity of CYAD-01 administered concurrently with FOLFOX chemotherapy (a combination of 5-fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC). Follow-up assessment of patients based on response evaluation criteria in solid tumors (RECIST) from dose level 1 of the trial confirmed one patient achieved a partial response and two patients experienced disease stabilization. Full data from the SHRINK Phase 1 trial are expected in 2019.
  • In December 2018, Celyad initiated the alloSHRINK trial evaluating the non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable mCRC. To date, no relevant treatment related toxicity has been observed in the first subject enrolled in the trial. Topline data from alloSHRINK trial are expected in the second half of 2019.

 

About CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient's T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the chimeric antigen receptor NKG2D of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signaling of the TCR complex, which is responsible for Graft versus Host Disease (GvHD) and could therefore reduce or eliminate GvHD in patients treated with CYAD-101.

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