GC Cell Affiliate, 'AB-101' Designated as FDA Fast Track

GC Cell (GC Cell) announced on the 23rd that its U.S. affiliate Artiva Biotherapeutics' lupus nephritis treatment AlroNK (development code AB-101) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for combination therapy with rituximab or obinutuzumab (brand name Gazyva).

Artiva Biotherapeutics Logo [Photo by Artiva]

Fast Track is a system established by the FDA to expedite the development and review process of new drugs. Drug developers can apply for accelerated approval after completing Phase 2 clinical trials and priority review after completing Phase 3 clinical trials. Lupus nephritis is a complication of systemic lupus erythematosus. Lupus is an autoimmune disease in which the body's immune system attacks various parts of the body, causing chronic inflammation. It is estimated that there are 5 million lupus patients worldwide, of whom about 40% progress to lupus nephritis. Especially, patients with end-stage lupus nephritis require hemodialysis and kidney transplantation.

This designation was made for Artiva's clinical trial of the first allogeneic chimeric antigen receptor (CAR)-T or natural killer (NK) cell therapy for autoimmune diseases approved by the FDA in August. Artiva is currently conducting a Phase 1 clinical trial in the U.S. to evaluate the safety and efficacy of combination therapy of AlroNK and rituximab, a CD20 antibody therapeutic agent, in patients with grade 3 or 4 relapsed or refractory lupus nephritis. Rituximab is a targeted anticancer drug known as MabThera and its biosimilar Truxima.

AlroNK is an off-the-shelf NK cell therapy derived from cryopreserved umbilical cord blood. It enhances antibody-dependent cellular cytotoxicity (ADCC) mediated by antibodies. It is expected that efficacy will be higher when combined with antibodies or engagers that bind well to tumor cells. Engagers refer to substances that bind to specific proteins expressed on cancer cells and immune cells, respectively. Additionally, since it is an off-the-shelf product that overcomes the cultivation and manufacturing difficulties of existing CAR-T therapies, it has the advantage of allowing drug administration and management in outpatient settings. It is also explained that it can be supplied at a reasonable price compared to existing CAR-T therapies that must be custom-made.

Fred Aslan, CEO of Artiva, said, “Through this FDA Fast Track designation, we have gained the opportunity to provide AlroNK to patients suffering from autoimmune diseases as soon as possible,” and added, “We observed that combination therapy of rituximab and AlroNK can induce B cell reduction in patients with late-stage B cell cancer, and although it has a mechanism very similar to B cell-targeted autologous CAR-T therapies, it has more advantages in terms of safety, so we expect that malignant tumor side effects will not occur.”

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