Healios Secures Funding for eNK® Cell Commercial Manufacturing Process

TOKYO, Jul 27 (Pulse News Wire) – HEALIOS K.K. (4593.T) announced that its research and development project aimed at commercial manufacturing processes for AKT-01/HLCN061, a genetically engineered NK cell therapy targeting malignant pleural mesothelioma, was selected for support under the Ministry of Health, Labour and Welfare’s (AMED) fiscal year 2026 “Regenerative Medicine and Gene Therapy Industrialization Promotion Project.” Under this initiative, HEALIOS will receive up to ¥79.9 million annually (including indirect expenses).

The total funding available over three years, from the time of approval until the end of fiscal year 2028, could reach approximately ¥240 million. Direct costs up to 30% of indirect expenses are eligible for assistance, and a combined amount equaling two-thirds of direct costs plus up to 30% will be granted as aid. This project focuses on establishing a GMP-compliant manufacturing process using a 50L bioreactor for large-scale production of AKT-01/HLCN061, which involves genetically modified iPSC-derived NK cells.

The aim is to enhance tumor-killing efficacy while improving patient immune recruitment and infiltration characteristics. HEALIOS collaborates with Akatsuki Therapeutics on this endeavor. In addition, HEALIOS previously secured funding for AKT-01/HLCN061 through a similar program in fiscal year 2024.

The company expects no immediate impact on its consolidated performance for the fiscal year ending December 2026 but will promptly disclose any significant developments related to this project.