NKGen Biotech Partners With HekaBio To Advance Troculeucel Cell Therapy For Alzheimer’s And Parkinson’s In Japan

NKGen Biotech has entered a strategic partnership with Tokyo-based HekaBio to advance the development and commercialization of its autologous NK cell therapy, troculeucel, in Japan. The collaboration follows HekaBio’s recent equity investment in NKGen and marks a significant step in expanding troculeucel’s global footprint, particularly in the field of neurodegenerative diseases.

“Japan has always had an advanced progressive health care system where great attention has been placed on the use of novel autologous cell therapies for prevention, longevity, and wellness as well as for the treatment of more chronic illnesses. I am convinced that HekaBio’s clinical, regulatory, and commercial expertise will guide us to satisfy all regulatory requirements, find the best local manufacturing partner to make our therapy readily available, and ultimately develop the best commercial strategy for Japan. We are very excited to partner with HekaBio,” said Paul Y. Song, MD, Chairman and Chief Executive Officer (“CEO”) of NKGen. 

Under the agreement, HekaBio will manage clinical trials and regulatory submissions in Japan, working with the Pharmaceuticals and Medical Devices Agency (PMDA) to gain approval for troculeucel in treating conditions such as Alzheimer’s and Parkinson’s diseases. The therapy, which utilizes a patient’s own natural killer (NK) cells, is non-genetically modified and fits within Japan’s regenerative medicine framework that allows for faster clinical adoption compared to other global markets.

“Dementia, particularly Alzheimer’s Disease, and other neurodegenerative diseases together present significant health and social challenges in Japan due to the country’s aging population. We are very excited about our partnership with NKGen and look forward to advancing troculeucel for the benefit of patients and society,” said Rob Claar, CEO of HekaBio.

The HekaBio will speed up the first patient dosing in 12 months based on its regulatory knowledge and domestic partner network. In addition to the target markets, in terms of treating hard-to-cure diseases, the partners anticipate that troculeucel could have a role in the wellness and longevity sectors in Japan, as the population of the country grows old. The partnership is likely to speed up the commercialization process of troculeucel in the market and support the capability of NKGen as an innovative player in immunotherapy.