GC Cell's AB-101 NK therapy achieves FDA fast-track status

South Korea's bio firm GC Cell announced on Wednesday that its US affiliate Artiva Biotherapeutics has received fast-track designation from the US Food and Drug Administration (FDA) for its natural killer (NK) cell therapy candidate AB-101.

AB-101 is a cord blood-derived treatment aimed at harnessing the body's immune system to fight cancer. GC Cell transferred the technology for this product to Artiva.

The treatment is currently undergoing phase 1 and 2 clinical trials for patients with recurrent and intractable B-cell non-Hodgkin lymphoma, including those who have failed to respond to chimeric antigen receptor T cell (CAR-T) treatment.

The FDA's fast-track designation is given to drugs that show potential for excellent efficacy against life-threatening diseases and are in need of quick development.

GC Cell, which was created through the merger of GC Green Cross Lab Cell and GC Green Cross Cell, is a corporation focused on the development and production of treatments using immune cells and stem cells.

Write to Jeong Min Nam at peux@hankyung.com