Celyad – Celyad announces the approval to initiate its NKR-2 CAR-T Clinical Trial in Belgium
Celyad announces the approval to initiate its NKR-2 CAR-T Clinical Trial in Belgium
Sciences › Immuno-oncology November 21, 2016
Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell therapies, today announces the approval in Belgium to initiate the THINK clinical trial. THINK is the 2nd clinical trial of its NKR-2 product candidate, a CAR-T cell therapy using NKG2D ligands as a target, to evaluate safety and efficacy in seven cancer indications including both solid and hematological malignancies.
THINK (THerapeutic Immunotherapy with NKR-2) is a multinational open-label Phase Ib probe to assess the safety and clinical activity of numerous administrations of autologous NKR-2 T-cells in seven, refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and numerous myeloma).
This trial will be conducted in the US and in Europe. It contains a dose escalation and an extension stage. The dose escalation will be conducted in parallel in the solid tumor and in the liquid cancer groups, while the extension phase will evaluate in parallel each tumor independently.
The dose escalation design will include three dose levels adjusted to bod weight: up to 3×10 eight , 1×10 nine and 3×10 nine NKR-2 T-cells. At each dose, the patients will receive three successive administrations, two weeks apart, of NKR-2 T-cells at the specified dose. The dose escalation part of the investigate will enroll up to twenty four patients while the extension phase would enroll eighty six extra patients.
The seven indications evaluated in the THINK trial were selected based on evidence generated in the pre-clinical settings and in the very first explore recently ended (a Phase I single injection, dose escalation explore evaluating NKR-2 T-cells in twelve patients suffering from Acute Myeloid Leukemia (AML) or Numerous Myeloma (MM) at Dana Farber Cancer Institute in Boston, MA, USA).
Dr. Christian Homsy, CEO of Celyad commented: «We are enormously glad to be able to commence this next phase of the clinical development program of NKR-2, building on the successful outcome of the single dose, dose escalation trial, to be introduced at ASH. We now look forward to treating the very first patients in Belgium, and to receiving FDA clearance to initiate the trial at our US-based sites.»
Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad added: «We are excited to initiate this numerous tumor explore with key cancer institutions in Belgium. While immunotherapy is rapidly converting the treatment of patients with cancer, there remains a significant unmet medical need for more effective therapies. It is our hope that Celyad’s NKR-2 T-cells have the potential to be truly disruptive in the way we treat cancer and this investigate is one more step towards that purpose.»
About Celyad
Developing breakthrough pioneering therapies for life-threatening diseases.
Celyad is a biopharmaceutical company, specialized in cell therapy, that is developing landmark technologies aimed at treating severe diseases with poor prognosis. Our scientific treatment is inspired by the natural mechanisms that are used by the figure to fight disease.
