NKGen Biotech and HekaBio Partner to Launch New NK Cell Therapy in Japan

NKGen Biotech and HekaBio Came Together to Bring New NK Cell Therapy to Japan

Announcement

NKGen Biotech, a US-headquartered clinical-stage biotechnology company with a strong focus on the development and commercialization of novel autologous and allogenic natural killer (NK) cell therapies, announced its partnership with Japan-based HekoBio K.K. for accelerating regulatory, manufacturing, and commercial developments of troculeucel, NKGen’s autologous NK cell therapy in Japan.

About Troculeucel

Troculeucel is an autologous and non-genetically modified cell therapy, has been allowed under the regenerative medicine regulations of Japan. The therapy has been devised to offer an accelerated path with fast feedback to patients. Troculeucel also supports counties gaining population in the longevity/wellness space.

What Critical Role will HekaBio play for Troculeucel in Japan?

HekaBio has invested heavily in the common equity of NKGen. With Japan’s pharmaceutical and medical device agency for pre-market approvals to troculeucel in various neurodegenerative disease indications like Parkinson’s and Alzheimer’s disease, HekaBio is expected to lead all clinical trials in Japan and review all regulatory approvals. The company has announced the leveraging of regulations and its domestic strategic partnership networks for the first dose of this cell therapy in Japanese patients by the next 12 months.

Leader’s Statements

Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen, states that, “HekoBio’s expertise in clinical, regulatory, and commercial sectors will help NKGen to meet all regulatory needs & requirements. The HekoBios has been a great local manufacturing partner to the company, making their cell therapy more available, accessible, and ultimately developing the best commercial strategy for Japan.”

Rob Claar, CEO of HekaBio, said, “HekaBio is very excited to collaborate with NKGen and advancements in troculeucel for more benefit of Japan’s patients and society. Due to Japan’s aging population is facing spectacular health and social challenges due to the rising prevalence of diseases like dementia, especially Alzheimer’s and other neurodegenerative diseases.’