NKGen Biotech and HekaBio Enter Strategic Partnership to Bring Novel NK Cell Therapy to Japan

Core Viewpoint - NKGen Biotech has formed a strategic partnership with HekaBio to accelerate the development of its autologous NK cell therapy, troculeucel, in Japan, targeting neurodegenerative diseases such as Alzheimer's and Parkinson's [1][2][3] Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [6] - HekaBio is a Japan-based healthcare platform that accelerates patient access to global medicines and MedTech, focusing on early-stage opportunities in CNS, oncology, and healthy longevity [8][9] Product Development - Troculeucel is an autologous, non-genetically modified cell therapy positioned to be a first-in-class treatment for several intractable neurodegenerative diseases [1][4] - The therapy is expected to be offered to patients in Japan on an accelerated path due to favorable regenerative medicine regulations, with first dosing aimed within the next 12 months [4][5] Regulatory and Clinical Strategy - HekaBio will lead all clinical trials in Japan and manage regulatory activities with the Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel [3][4] - The partnership aims to leverage HekaBio's expertise to meet regulatory requirements and establish local manufacturing partnerships for effective commercialization [5]