Nkarta Begins Investigator-Led Trial of NKX019 for Lupus

SOUTH SAN FRANCISCO, Calif., July 24, 2024 – Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company known for developing engineered natural killer (NK) cell therapies, has announced that Columbia University Irving Medical Center (CUIMC) researchers have begun an investigator-sponsored trial (IST) of NKX019. This therapy is Nkarta's allogeneic, CD19-directed chimeric antigen receptor (CAR) NK-cell therapy, aimed at patients with systemic lupus erythematosus (SLE). The IST expands the clinical evaluation of NKX019 for lupus. In June 2024, Nkarta commenced its Phase 1 clinical trial, Ntrust-1, for NKX019 in patients with lupus nephritis (LN).

The Phase 1 IST, single-center, single-arm, and open-label, is led by Dr. Anca D. Askanase, Director of the Lupus Center at CUIMC and Director of Rheumatology Clinical Trials. Dr. Askanase remarked, "People with lupus face significant challenges, including years of exposure to toxic/partially effective medications. Cell therapy provides the hope of long-term, medication-free remission."

The CUIMC IST is set to enroll up to six patients with SLE, irrespective of renal involvement. It will examine safety and clinical outcomes in a potentially different subset than Ntrust-1. Furthermore, translational and biomarker studies, covering autoantibodies, cytokine profiles, and pharmacokinetics, are planned. Patients will receive NKX019 on Days 0, 7, and 14, following single-agent lymphodepletion with cyclophosphamide. Patient screening has already started.

Systemic lupus erythematosus (SLE) is an autoimmune disease where the immune system attacks the body's tissues. This dysregulated immune response generates antibodies that can damage various organs, including the skin, joints, kidneys, heart, and brain. Symptoms can range from fatigue and joint pain to severe organ damage. SLE can also result in lupus nephritis (LN), a severe condition affecting the kidneys.

David R. Shook, M.D., Nkarta’s Chief Medical Officer and Head of R&D, stated, "With its reduced-toxicity lymphodepletion regimen, enabled by cytokine engineering, we believe that NKX019 has potential to reach more patients, including those with less advanced disease. We’re eager to collaborate with our academic partners at Columbia and look forward to making a difference in the lives of people living with autoimmune diseases like lupus."

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that employs NK cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for improved cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for enhanced persistence and activity without external cytokine support. CD19 serves as a biomarker for normal B cells and those involved in autoimmune disease and B cell-derived malignancies.

Nkarta is a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf, on-demand NK cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta aims to create a pipeline of future cell therapies designed for extensive therapeutic efficacy and intended for broad accessibility in outpatient treatment settings.