Celyad said FDA has accepted the company’s Investigational New Drug application for CYAD-101, the first non-gene edited allogeneic clinical program. FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.
CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s autologous CYAD-01 CAR-T and a novel peptide, TCR Inhibiting Molecule, an inhibitor of TCR signaling. TCR signaling is responsible for the graft vs. host disease, and tampering or eliminating its signaling could therefore reduce or eliminate GvHD.
In CYAD101, the TIM peptide is encoded alongside the CAR construct allowing allogeneic T cell production through a single transduction step. CYAD-101 benefits from using a manufacturing process that is highly similar to Celyad’s well established process for its clinical autologous CAR-T cell products.
While autologous CAR-T therapies now have well established efficacy in B cell malignancies, the approach can be more challenging for some patients, especially those where the quality of the apheresis is poor.
