Benzinga | Jul 14, 2020 05:25AM EDT

Celyad Oncology Announces FDA Clearance of IND Application for CYAD-211, First shRNA-based, Non-Gene Edited Allogeneic CAR T Therapy

Celyad Oncology SA (NASDAQ:CYAD) today announced that the company's Investigational New Drug (IND) application for CYAD-211, the company's first-in-class short hairpin RNA (shRNA)-based allogeneic CAR T candidate and second non-gene edited off-the-shelf program, is in effect with the U.S. Food and Drug Administration (FDA). The company's lead allogeneic candidate from its next-generation CYAD-200 series, CYAD-211 targets B-cell maturation antigen (BCMA) for the treatment of relapsed / refractory multiple myeloma (r/r MM). CYAD-211 is engineered to co-express a BCMA-targeting chimeric antigen receptor and a single shRNA, which interferes with the expression of the CD3 component of the T-cell receptor (TCR) complex.

"The FDA's permission to begin the Phase 1 clinical trial of our lead shRNA-based allogeneic candidate CYAD-211 is a watershed moment for our organization," commented Filippo Petti, Chief Executive Officer of Celyad Oncology. "Today's announcement demonstrates our ability to advance in parallel multiple off-the-shelf product candidates based on differentiated non-gene edited allogeneic technologies into the clinic. In addition, our team has delivered on incredible timelines for the CYAD-211 program, moving the project from concept to an effective IND in under two years. We are excited to have the CYAD-211 IND in effect to initiate the Phase 1 trial by year-end 2020 for this first-in-class CAR T candidate for patients with multiple myeloma and look forward to accelerating the development of additional shRNA-based allogeneic candidates from our CYAD-200 series towards clinical trials."