Celyad Announces FDA Acceptance of IND Application for CYAD-101, a First-in-Class Non-Gene Edited Allogeneic CAR-T Candidate
24 July 2018
- FDA acceptance of IND for world’s first non-gene edited allogeneic CAR-T clinical program
- First of a family of non-gene edited allogeneic CAR-T, targeting colorectal cancer to build on the experience from the SHRINK autologous CAR T program
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 therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program. The 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.
Dr. Christian Homsy, CEO of Celyad: “We are pleased to have achieved this important milestone. 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.”
CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s auto-logous CYAD-01 CAR-T and a novel peptide, TIM (TCR Inhibiting Molecule), an inhibitor of TCR signaling. TCR signaling is responsible for the Graft versus Host Disease (GvHD), and tampering or eliminating its signaling could therefore reduce or eliminate GvHD. In CYAD-101, 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. Allogeneic CAR-T cell therapy may provide an alternative approach for this patient population, utilizing cells manufactured from a healthy donor which could allow greater reproducibility and reduced manufacturing costs.