Abstract

Healios’ eNK Cells: Research, Development and Manufacturing of an Innovative Treatment for Solid Tumors

Hardy TS Kagimoto, Founder, Chairman and CEO, HEALIOS K.K.

HEALIOS K.K. (“Healios”) has developed engineered NK cells (“eNK” cells), a novel gene-edited NK cell therapy designed to possess excellent efficacy for solid tumors. Healios’ eNK cells are produced from a proprietary iPSC line, which has been genetically modified for enhanced anti-tumor activity. The eNK cell platform is uniquely differentiated from other approaches, having been engineered with five enhancements that are important for cancer killing activity. This comprehensive set of functional enhancements - and in particular unique migratory and immune cell recruitment features – position Healios’ eNK cells with the potential to penetrate solid tumors and, once there, initiate robust tumor killing activity. Preclinical studies have demonstrated superior antitumor activity of eNK cells in comparison to unmodified iPSC-derived and peripheral blood NK cells in vitro and in vivo. In addition, eNK cells have been generated in a high quality, clinical grade form and are currently manufactured in Healios’ in-house GMP facility at the Kobe Center for Medical Innovation utilizing a proprietary, automated, feeder-cell free 3D perfusion bioreactor system at an efficient scale of 100 billion cells per batch. Healios is continuing with its testing of eNK cells both in its laboratory facilities in Kobe as well as through joint research with several academic institutions. Healios has begun pre-clinical consultations with the PMDA and aims to begin clinical trials using eNK cells in 2024.