Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for AlloNK (also known as AB-101), in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN). AlloNK is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved NK cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity (ADCC). This IND clearance marks the first for an allogeneic, off-the-shelf NK or CAR-T cell therapy in autoimmune disease.
AlloNK is currently being investigated in two cancer clinical trials in combination with antibody or NK-engager biologics. Artiva presented data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrating the therapeutic potential and favorable safety profile of AlloNK in combination with rituximab in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
“Seminal clinical data has been generated using autologous CAR-T cells suggesting that a deeper B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis. However, the use of autologous CAR-T cells requires apheresis, likely hospitalization, and the potential for serious side effects,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B-cells, is already driving complete responses in late line B-NHL patients in an ongoing Phase 1 study by enhancing the activity of rituximab. Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.”
As Artiva broadens the applications of AlloNK into autoimmune disease, the company has assembled an advisory board of experts in SLE and LN:
- Kenneth Kalunian, M.D., is a clinician and Professor of Medicine at UC San Diego, where he directs the Lupus Research and Clinical Center of Excellence. Dr. Kalunian participates in multiple lupus clinical networks, including as a founding member of both the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) and the Lupus Clinical Investigators Network (LuCIN).
- Jill Buyon, M.D., is a clinician and Professor of Rheumatology and Director of the Division of Rheumatology at New York University (NYU) School of Medicine, and Director of the NYU Lupus Center. Dr. Buyon has published more than 200 papers in peer-reviewed science journals and has been an active member of the Accelerating Medicines Partnership.
- Maureen McMahon, M.D., is a clinician and Professor of Medicine / Rheumatology at UCLA and site director of the UCLA Lupus Clinical Trials Network. Her research and clinical work have focused on identifying new treatments for SLE.
- Brad Rovin, M.D., is a Professor of Medicine and Pathology and Director of the Division of Nephrology at The Ohio State University, Wexner Medical Center. Dr. Rovin studies the immunopathogenesis of glomerular and autoimmune diseases and is heavily involved in clinical trial development and design for investigator-initiated and industry-sponsored trials.
“Although rituximab has been used off-label in the treatment of SLE, rituximab alone has been shown to give incomplete B-cell depletion. The addition of allogeneic NK cells as an ADCC-enhancing therapy could significantly enhance rituximab’s ability to drive deeper levels of B-cell depletion,” said Dr. Kalunian. “Furthermore, SLE patients may have lower levels of NK cells than healthy subjects, and these cells may be functionally impaired. An effective off-the-shelf cell therapy that can be administered and managed in the community setting could be well received by lupus patients and physicians.”