2nd Edition of Cell & Gene Therapy World Conference 2026

Abstract

Natural Killer (NK) cells eliminate circulating tumor cells to suppress cancer metastasis, which is responsible for as much as 90% of cancer-associated mortality.  However, the biggest challenges facing NK cells as therapeutics are: 1) Industrial scale manufacture of healthy and efficacious NK cells for patients; 2) Efficient supply chain  including: (a) sustainable cell sources for continuous production; (b) cryopreservation and transportation---the key is that cryopreservation and thawing do not lead to NK cell death. HebeCell has developed a robust proprietary 3D-ProtoNK platform with superior scalability and consistency compared to existing approaches for industrial scale manufacturing of pluripotent stem cell (PSC)-NK cells with recovery of  >85% live cells after cryopreservation:  game changing, cost-effective and off-the-shelf PSC-NK products for all patients around the world. In addition to expressing common NK activating and inhibitory receptors, about 80% of our PSC-NK cells are CD8a+ (designated as ProtoNKTM), which are substantially more potent than current other sources of NK cells.  GLP toxicology and tumorigenicity studies showed no association with any preterminal mortality, clinical observations, and tumor formation.  IND enabling animal studies demonstrated that ProtoNK cells are particularly effective in treating metastatic cancers: significantly inhibited/prevented Ewing sarcoma lung and liver metastasis, paving the way for metastatic cancer treatment. Our Investigational New Drug (IND) has been cleared by US FDA allowing the Phase 1/1b clinical study evaluating ProtoNK™ (HC101) in adolescent and young adult patients with recurrent or refractory Ewing sarcoma to proceed in the United States, which will start enrollments in middle of 2026. In summary, our proprietary 3D ProtoNK platform allows scalable and reproducible production of ProtoNK cells, which will be affordable and available for ordinary patients and can be rapidly deployed worldwide.