GC Cell's 'HER2-Targeted Cell Therapy' Approved for Advanced Regenerative Medicine Clinical Research and Regulatory Sandbox

GC Cell announced on the 31st that its HER2-targeted allogeneic CAR-NK cell therapy, 'AB-201 (GCC2003),' has received simultaneous approvals for its advanced regenerative medicine clinical research plan from the Ministry of Health and Welfare and the Ministry of Food and Drug Safety, as well as regulatory sandbox approval from the Ministry of Trade, Industry and Energy.

This approval marks the first advanced regenerative medicine clinical research in Korea targeting HER2-positive solid tumors using allogeneic CAR-NK cells. Yonsei Cancer Center (Professor Jung Minkyu) will conduct research on patients with advanced HER2-positive gastric cancer and gastroesophageal junction cancer, while Konyang University Hospital (Professor Choi Jongkwon) will focus on patients with advanced HER2-overexpressing breast cancer. GC Cell will play a key role in the manufacturing, storage, transportation, and management of AB-201 (GCC2003) for this clinical research.

Notably, this study is the first official case of applying the regulatory sandbox system to advanced regenerative medicine clinical research, temporarily allowing the use of 'imported cells' as raw materials for therapy, which are not explicitly stipulated under current regulations. This is regarded as a significant achievement, as it expands treatment opportunities and accelerates the clinical application of new technologies by utilizing overseas source cells within Korea's advanced regenerative medicine system.

GC Cell CEO Won Sungyong stated, "This approval is a decisive milestone in accelerating the commercialization of allogeneic CAR-NK-based solid tumor therapies in Korea. Through collaboration with Yonsei Cancer Center and Konyang University Hospital, we will secure clinical proof-of-concept data more quickly and safely within the advanced regenerative medicine framework and further strengthen our global competitiveness."

Jung Minkyu, Professor of Oncology at Yonsei Cancer Center, explained, "Although the potential of immune cell therapy for patients with advanced HER2-positive gastric and gastroesophageal junction cancer is still at an early stage, CAR-NK technology can open new treatment opportunities through mechanisms distinct from existing anticancer drugs or immune checkpoint inhibitors. Confirming the safety and early antitumor activity of NK-based immunotherapy through this study will be an important turning point in the future development of immunotherapy for solid tumors."

Choi Jongkwon, Professor of Hematology and Oncology at Konyang University Hospital, stated, "Advanced HER2-overexpressing breast cancer often faces limited treatment options due to resistance issues. CAR-NK cell therapy, based on allogeneic umbilical cord blood-derived cells, offers high clinical value due to its ability to be administered rapidly. This study will serve as an opportunity to enhance both the safety and scientific standards of cell therapy clinical research within Korea's advanced regenerative medicine system."

GC Cell plans to focus its research and development capabilities on securing clinical evidence, verifying the safety and efficacy of CAR-NK therapies, and establishing institutional standardization, centering on this advanced regenerative medicine track.

This content was produced with the assistance of AI translation services.