FDA lifts hold on CYAD-101-002 Phase Ib trial

Belgian clinical-stage biotech Celyad Oncology (Euronext & Nasdaq: CYAD), which is focused on the discovery and development of chimeric antigen receptor T cell (CAR-T) therapies for cancer, yesterday announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on the CYAD-101-002 (KEYNOTE-B79) Phase Ib trial after the company made changes to the eligibility criteria for the trial.

Brussels-listed shares of Celyad were recently up 32.5% to 2.30 euros yesterday, while its US-listed shares rose 39% in pre-market trading to $2.37. The stock added a further 5% to 2.39 euros this morning.

“We are pleased that the FDA lifted the clinical hold on this trial. We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR-T,” said Dr Charles Morris, chief medical officer of Celyad Oncology.