GC Cell said on Thursday that its U.S. affiliate, Artiva Biotherapeutics (Artiva), has received investigational new drug (IND) approval from the FDA for the phase 1 clinical trial of AB-101, an NK cell therapy for lupus nephritis (LN).
This IND approval marks the first for an allogeneic CAR-T or NK cell therapy in autoimmune disease., GC Cell said.
AB-101, an allogeneic NK cell therapy developed by GC Cell, is a genetically unmodified NK cell derived from umbilical cord blood. It enhances antibody-dependent cytotoxicity (ADCC) to induce potent anti-cancer effects in combination with antibody/engager and is currently undergoing a phase 1/2 clinical trial in the U.S. as a combination therapy with rituximab for relapsed/refractory B-cell non-Hodgkin lymphoma.
Moreover, AB-101 is a cord blood-derived allogeneic therapy that can be cryopreserved in an off-the-shelf form that does not require hospitalization for lymphocyte apheresis and can be treated in an outpatient setting, increasing patient convenience.
Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by abnormal B-cell function and autoantibody production, leading to end-organ damage and risk of death.
The drug candidate is a highly anticipated first-in-class allogeneic NK cell therapy that was granted FDA Fast Track designation in January. It is also being studied in a phase 2 trial in combination with Affiimed's NK cell engager AFM13 in Hodgkin lymphoma.
"The combination of AB-101 with rituximab, an anti-CD20 antibody that targets B cells, has shown complete remission in non-Hodgkin lymphoma in phase 1,” said Artiva Biotherapeutics CEO, Fred Aslan. “We expect the combination of AB-101 and rituximab to efficiently induce B-cell elimination in patients with lupus nephritis in an off-the-shelf, patient-administered, manageable regimen in an outpatient setting."
"NK cell therapy is expanding its scope by being applied to autoimmune diseases after anticancer drugs,” said GC Cell CEO James Park. “We will work closely with Artiva to expand its development in the APAC region as the drug's development progresses."
Presently, there are an estimated 5 million people with lupus worldwide, of which 2 million will develop LN. Serious complications occur in about 40 percent of SLE cases, and patients with end-stage LN require hemodialysis and kidney transplantation.