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CYNK-101 is an investigational, cryopreserved, off-the-shelf, allogeneic cell therapy derived from human placental CD34+ hematopoietic stem cells and differentiated into natural killer (NK) cells. These NK cells are genetically engineered to overexpress a high-affinity and protease-resistant variant of the CD16 receptor (FCGRIIIA), enhancing their ability to mediate antibody-dependent cellular cytotoxicity (ADCC). The primary mechanism involves augmenting the efficacy of tumor-targeting monoclonal antibodies by increasing ADCC against cancer cells. Developed by Celularity, CYNK-101 has been studied in combination with standard chemotherapy and antibody therapeutics such as trastuzumab and pembrolizumab for advanced HER2-positive gastric and gastroesophageal junction adenocarcinoma. It has received orphan drug designation for these indications but has not been approved for any use[1][3][4][5][6].
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