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**HLCN061** is an allogeneic gene-engineered human induced pluripotent stem cell derived natural killer cell therapy being developed by Healios in collaboration with Akatsuki Therapeutics for solid tumors. The product is an off-the-shelf iPSC-derived NK cell therapy designed to improve antitumor activity, persistence, tumor homing, and recruitment of host immune cells. Reported engineered features include expression of interleukin 15, C C motif chemokine receptor 2B, C C motif chemokine ligand 19, high-affinity CD16a, and natural killer group 2D with DAP10 support, with preclinical data showing enhanced cytotoxicity and antibody-dependent cellular cytotoxicity against multiple solid tumor models including hepatocellular carcinoma, lung cancer, malignant pleural mesothelioma, and metastatic uveal melanoma. As of 2026, it appears to remain in preclinical or early translational development with first-in-human testing planned but not yet confirmed as initiated.
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