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

AB-101 is currently undergoing phase 1 and 2 clinical trials for patients with recurrent and intractable B-cell non-Hodgkin lymphoma

GC Cell's AB-101 NK therapy achieves FDA fast-track status
Jeong Min Nam 1
2023-02-02 12:09:08 peux@hankyung.com
Bio & Pharma


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
##GC Cell fast track ##CAR T ##AB-101 FDA

GC Biopharma's Sanfilippo treatment eligible for FDA priority review

GC Biopharma's Sanfilippo treatment eligible for FDA priority review

GC Biopharma headquarters  GC Biopharma (Green Cross Corp.) said on Wednesday that its Sanfilippo type A treatment, which is under joint development with Novel Pharma, a bio-venture specializing in orphan drugs, has received rare pediatric disease designation (RPDD) from the US Food and Dr

GC Biopharma confirms safety of flu vaccine in phase 1 trial

GC Biopharma confirms safety of flu vaccine in phase 1 trial

GC Biopharma Hwasun plant South Korea's leading pharmaceutical company GC Biopharma (Green Cross Corp.) said on Thursday that it has confirmed the safety and immunogenicity of the patch-type influenza vaccine MIMIX-Flu, which is under development jointly with Vaxess Technologies of the United S

GC Lab Cell, Artiva ink $1.9 bn deal with MSD

GC Lab Cell, Artiva ink $1.9 bn deal with MSD

South Korea-based biotechnology company Green Cross Lab Cell Corp. (GC Lab Cell) and its US-based subsidiary have inked a $1.9 billion deal to export the latest cell therapy platform technology to the global biopharmaceutical company Merck Sharp & Dohme Corp. (MSD), the company announced o
(* comment hide *}