The FDA granted orphan drug designation to CYNK-101, an investigational natural killer cell-based therapy for treatment of advanced HER2/neu-positive gastric or gastroesophageal junction adenocarcinoma.
CYNK-101 (Celularity) is a gene-edited, allogeneic natural killer (NK) cell therapy composed of human placental hematopoietic stem cells engineered to express a high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant.