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]

Core Insights - NKGen Biotech, Inc. presented updated Phase 1 clinical data for troculeucel, a novel NK cell therapy for moderate Alzheimer's disease, at the AD/PD™ 2025 conference [3][4] - The highest dose of troculeucel administered was 6 billion cells per treatment, with significant cognitive improvements observed in two out of three patients after 12 months [1][4][5] - The company plans to evaluate troculeucel's safety and efficacy in a randomized, placebo-controlled Phase 2a trial [2][4] Group 1: Clinical Trial Results - In the Phase 1/2a trial, three patients received troculeucel intravenously every three weeks, with two patients completing 17 doses and one patient completing 10 doses [4] - After 12 months, two patients improved from moderate to mild Alzheimer's disease, with one patient achieving a CDR-SB score of 4.5 [1][4][5] - No drug-related adverse reactions were reported, and all patients showed stable or improved cognitive scores across various scales [4][5] Group 2: Biomarker Analysis - At 6 months, all patients exhibited decreased levels of Glial Fibrillary Acidic Protein (GFAP) in both CSF and plasma, correlating with cognitive improvements [4][5] - Improvements in the CSF and plasma Amyloid Beta (Aβ) 42/40 ratio were noted at 12 months, while p-Tau levels remained stable [4][5] Group 3: Company Overview - NKGen Biotech is focused on developing innovative autologous and allogeneic NK cell therapeutics for neurodegenerative disorders and cancers [6][7] - Troculeucel is the International Nonproprietary Name (INN) for SNK01, marking a significant step towards market introduction [6]