Celyad have announced that the FDA have approved the company’s Investigational New Drug (IND) application for CYAD-101, the world’s first non-gene-edited allogeneic CAR-T clinical program targeting colorectal cancer.
CYAD-101, the first allogeneic CAR-T cell product developed by Celyad, encodes the autologous CYAD-01 CAR-T as well a TCR signalling inhibitor, the novel peptide known as TCR Inhibiting Molecule (TIM). Altering or eliminating TCR signalling could potentially limit or eliminate Graft versus Host Disease (GvHD). The TIM peptide is encoded in conjunction with the CAR construct in CYAD-101, which enables allogeneic T cell production via a single transduction step. The manufacturing process used for the production of CYAD-101 is very similar to the process used for Celyad’s clinical autologous CAR-T cell products. Utilizing cells manufactured from healthy donors may allow better reproducibility and lower manufacturing costs.
Following the IND approval, the FDA has indicated that the ‘Allo-SHRINK’ trial for the evaluation of safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy can proceed. Cyad-01, Celyad’s lead oncology candidate, has previously been assessed in a single dose escalation Phase I clinical trial for safety and clinical activity of multiple administrations of autologous CYAD-01 cells in seven refractory cancers including five solid tumors and two hematological tumors.
“Celyad is the first company clinically evaluating a non-gene edited CAR-T candidate, which, we believe, offers significant advantages over gene edited approaches. Our non-gene edited program consists of a family of technologies aimed at reducing or eliminating T cell receptor (TCR) signaling without requiring genetic manipulation. CYAD-101 is part of a robust clinical development plan, establishing the foundations of next generation CAR-T products.” commented Dr Christian Homsy, CEO of Celyad.
Source: Celyad Announces FDA Acceptance of IND Application for CYAD-101, a First-in-Class Non-Gene Edited Allogeneic CAR-T Candidate Press Release