The FDA has lifted the clinical hold on Celyad Oncology SA's (NASDAQ: 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 (NYSE: MRK) Keytruda (pembrolizumab) in refractory metastatic colorectal cancer with microsatellite stable (MSS) / mismatch-repair proficient disease.
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