GC Cell Technology-Based NK Cell Therapy Receives US FDA Phase 1 Clinical Trial Approval

Phase 1 Study of Rituximab and AB-101 Combination in Lupus Nephritis Patients

GC Cell (GCsel) announced on the 17th that its U.S. affiliate, Artiva Biotherapeutics, has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for the natural killer (NK) cell therapy 'AB-101' for lupus nephritis clinical Phase 1 trial.

The company explained that this IND approval is the first for allogeneic chimeric antigen receptor (CAR)-T or NK cell therapies in autoimmune diseases.

Systemic lupus erythematosus is an autoimmune disease characterized by abnormal B cell function and autoantibody production, leading to end-organ damage and risk of death. It is estimated that there are about 5 million lupus patients worldwide, of which 2 million progress to lupus nephritis. Lupus nephritis is a serious complication occurring in about 40% of systemic lupus erythematosus cases, and patients with end-stage lupus nephritis require hemodialysis and kidney transplantation.

AB-101, developed by GC Cell, is an allogeneic NK cell therapy derived from umbilical cord blood without genetic modification. AB-101 enhances antibody-dependent cellular cytotoxicity (ADCC) and induces a strong anticancer effect when combined with antibody engagers. Currently, a Phase 1/2 clinical trial is underway in the U.S. for relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHLL) in combination with rituximab.

GC Cell explained that AB-101, designated as a Fast Track by the FDA in January, is a first-in-class NK cell therapy candidate attracting attention. A Phase 2 clinical trial is also underway in combination with Apimed's NK cell engager 'AFM13' for Hodgkin lymphoma. Additionally, as an allogeneic therapy derived from umbilical cord blood, it is available as a frozen off-the-shelf product, which does not require hospitalization for lymphocyte collection from patients and can be administered in an outpatient setting, thus offering high patient convenience from a commercialization perspective.

Fred Aslan, CEO of Artiva, said, "We expect that the combination therapy of AB-101 and rituximab, as an off-the-shelf product that can be administered and managed in an outpatient setting, will efficiently induce B cell depletion in patients with lupus nephritis."

James Park, CEO of GC Cell, stated, "NK cell therapies are expanding their scope from oncology to autoimmune diseases. GC Cell plans to closely collaborate with Artiva and expand development to the Asia-Pacific (APAC) region based on the progress of development."

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