NKGen and HekaBio team up on NK Cell therapy in Japan

NKGen Biotech, Inc. is a clinical-stage biotech firm. They focus on NK cell therapies, both autologous and allogeneic. Now, they’ve teamed up with Tokyo’s HekaBio K.K. This partnership will help develop and market NKGen’s autologous NK cell therapy, troculeucel, in Japan. The collaboration follows HekaBio’s recent investment in NKGen through common equity.

HekaBio will lead clinical development in Japan. They will also handle regulatory talks with the Pharmaceuticals and Medical Devices Agency (PMDA). Their goal is to get pre-market approval for troculeucel for several neurodegenerative diseases, like Alzheimer’s and Parkinson’s.

Troculuecel is an autologous, non-genetically modified cell therapy. This means it can use Japan’s expedited approval pathway for regenerative medicine. As a result, patients can access it much faster than in other major global markets. HekaBio plans to use this framework with its domestic partners. They aim to start dosing the first patient within the next 12 months. Troculuecel may help with tough diseases. It also has promise in Japan’s growing wellness and longevity market.

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“Japan has embraced new autologous cell therapies. These therapies help treat chronic diseases and support preventive and wellness care,” said Dr. Paul Y. Song, Chairman and CEO of NKGen. HekaBio knows clinical, regulatory, and commercial areas well. This expertise will help us enter the Japanese market. We will find a top local manufacturing partner and create a strong commercial strategy. We’re thrilled to collaborate with them.”

Rob Claar, CEO of HekaBio, said, “Neurodegenerative diseases like Alzheimer’s are major medical and social issues in Japan’s aging society.” We are excited to partner with NKGen. We aim to advance troculeucel to boost patient outcomes and benefit society.”