Artiva Biotherapeutics, a clinical-stage company with a focus on delivering highly effective, off-the-shelf allogeneic natural killer (NK) cell-based therapies, has received FDA clearance for its Investigational New Drug (IND) application concerning AlloNK® (also known as AB-101). This clearance allows the company to explore the potential of AlloNK in combination with rituximab for treating systemic lupus erythematosus (SLE) in individuals with active lupus nephritis (LN).
AlloNK is an unaltered NK cell therapy candidate derived from cord blood, cryopreserved for enhanced antibody-dependent cellular cytotoxicity (ADCC). This IND clearance represents a significant milestone as it marks the first approval of an allogeneic, off-the-shelf NK or CAR-T cell therapy for autoimmune diseases.
At present, AlloNK is the subject of investigation in two clinical trials aimed at cancer treatment, administered alongside antibodies or NK-engager biologics. In combination with rituximab, an anti-CD20 antibody targeting B-cells, AlloNK has shown promising results, driving complete responses in late-line B-NHL patients during an ongoing Phase 1 study, thanks to its ability to enhance rituximab's effectiveness. The hypothesis is that AlloNK, when combined with rituximab, holds the potential to achieve deep B-cell depletion in LN patients, offering an off-the-shelf therapy that can be managed in an outpatient setting.
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune condition characterized by abnormal B-cell function and autoantibody production, leading to various clinical manifestations, including end-organ damage and an elevated risk of mortality. In the U.S., an estimated 160,000-320,000 patients are affected by SLE, with lupus nephritis (LN) being the most common end-organ manifestation, impacting about 40% of SLE patients. Moreover, more than 40% of individuals with severe LN may develop end-stage renal disease, necessitating dialysis or transplant within 15 years.
AlloNK® (AB-101) is a non-genetically modified NK cell therapy candidate derived from cord blood and cryopreserved for future use. Its design is aimed at enhancing ADCC and enabling its use in combination with monoclonal antibodies or innate-cell engagers in outpatient settings. Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to evaluate the safety and clinical efficacy of AlloNK, both as a standalone treatment and in combination with the anti-CD20 monoclonal antibody rituximab for patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL).
Additionally, Artiva is exploring the safety and clinical efficacy of AlloNK in combination with rituximab for patients with lupus nephritis. Artiva is also engaged in a Phase 2, open-label, multi-center, multi-cohort study (NCT05883449, LuminICE-203) in collaboration with Affimed N.V., which is examining a combination therapy involving AlloNK and Utilizing the innate cell engager AFM13 to treat individuals with relapsed/refractory CD30-positive lymphomas. The administration of AlloNK occurs in outpatient settings, involving multiple doses and cycles.
