GC Cell·Artiva's CAR-NK Therapy 'AB-201' Receives IND Approval for US Phase 1/2 Clinical Trial

[Asia Economy Reporter Lee Gwan-joo] GC Cell's (GC Cell) U.S. affiliate, Artiva Biotherapeutics, announced on the 21st that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical phase 1/2 trial plan (IND) of 'AB-201'.

AB-201 is being developed as a cord blood-derived chimeric antigen receptor (CAR)-NK cell therapy targeting solid tumors such as HER2-overexpressing breast and gastric cancers. Unlike CAR-T therapies that use the patient's own immune cells, it is an off-the-shelf NK cell therapy, a universal allogeneic cell therapy that can be used broadly without the need to wait for manufacturing time.

Fred Aslan, CEO of Artiva, said, "AB-201 is the first systemically administered HER2 CAR-NK candidate, targeting the most common HER2-overexpressing solid tumors, including breast and gastric cancers. Artiva's large-scale NK cell culture platform technology has the potential to treat thousands of patients from a single cord blood unit, demonstrating the capability to produce both off-the-shelf non-genetically modified cell therapies and genetically modified CAR-NK therapies."

AB-201 is one of the pipelines licensed to Artiva in 2020 by GC Cell, which holds the original NK cell therapy technology. Artiva was established in 2019 in San Diego, USA, by GC Cell and GC Green Cross Holdings as an NRDO (No Research, Development Only) entity for cell therapy development.