Abstract A020: Novel natural killer cell therapy using unique NK cell subset

Abstract We have developed a novel three-stage expansion protocol that enables cost-effective, feeder-free, and sorter-free expansion of a unique subset derived from the blood of healthy donors (apexNK® cells). This special NK cell subset differs distinctly from those obtained by other methods and shows > 1,000-fold higher expansion efficiency compared to the leading international competitors. To advance targeted NK cell therapies, we have engineered antibody-conjugated apexNK cells (Rituxan- and Herceptin-apexNK) using an improved, non-viral chemical conjugation technology (ACC® ). Building on this platform developed by Acepodia Biotech, we modified the technique to conjugate therapeutic antibodies to NK cells, which have demonstrated efficacy in animal models of hematological malignancies and solid tumors. We will soon progress to the Investigational New Drug application. The clinial trial of this non-viral, antibody-enhanced allogeneic NK therapy is expected to launch this year. This innovative therapy offers three major breakthroughs: 1. In contrast to previous phase I study of ACC-NK92 cell line, apexNK® cells are derived from peripheral blood of healthy donor; 2. antibody-cell conjugation is achieved via non-viral chemical methods, offering advantages over conventional CAR-T technologies requiring genomic editing which carry the risks of gene mutation and potential oncogenesis associated with off-target effects in traditional CAR techniques. 3. the process is shortened from several weeks for CAR generation to just 3 hours. Furthermore, expanded apexNK® cells can be cryopreserved during processing, allowing for on-demand production and real-time availability. This will reduce preparation time and cost, while mitigating the potential risks of off-target effects and secondary malignancies seen in CAR-based therapies. Thus, these features offer substantial economic value and represent a core competitive strength and key innovation of our team. We will focus on advancing the Herceptin-apexNK cell therapy (ACC101), which represents the most mature and developed of our current projects. In addition, to address unmet clinical needs in bile duct and ovarian cancers, and to target cancer stem cells, we have developed three novel CAR-NK cell therapies-Globo H, ESC02, and OGD2 CAR-NKs-using viral transduction technology. These cells exhibit 60–80% transduction efficiencies, exceeding international benchmarks, and have demonstrated specific cytotoxic activity against targeted cancer types. These CAR NKs are directed against novel targets and hold strong potential for technology licensing and clinical development. Citation Format: John Yu, Hsiu Hui Tsai, Alice L. Yu. Novel natural killer cell therapy using unique NK cell subset [abstract]. In: Proceedings of the AACR Immuno-Oncology Conference (AACR IO): Discovery and Innovation in Cancer Immunology: Revolutionizing Treatment through Immunotherapy; 2026 Feb 18-21; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Immunol Res 2026;14(2 Suppl):Abstract nr A020.