FDA Removes Clinical Hold On Celyad's Colorectal Cancer Trial

FDA Removes Clinical Hold On Celyad's Colorectal Cancer Trial
  • The FDA has lifted the clinical hold on Celyad Oncology SA's CYAD CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company made changes to the eligibility criteria for the 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 Charles Morris, Chief Medical Officer of Celyad Oncology.
  • In February, the company voluntarily paused the CYAD-101-002 trial to investigate reports of two fatalities in the study. 
  • The FDA subsequently put the trial on clinical hold in March.
  • The CYAD-101-002 Phase 1b trial evaluates CYAD-101 with Merck & Co Inc's MRK Keytruda (pembrolizumab) in refractory metastatic colorectal cancer with microsatellite stable (MSS) / mismatch-repair proficient disease.
  • Price Action: CYAD shares are up 28.1% at $2.23 during the premarket session on the last check Monday.
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