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Nkarta Initiates Clinical Trial of NKX019 in Lupus Nephritis with First Patient in Screening and Announces Pipeline Expansion to Additional Autoimmune Indications
Patient screening underway in Ntrust-1, the first U.S.-based clinical trial of an engineered NK cell therapy for the treatment of lupus nephritis IND cleared
About this update from Nkarta, Inc.
[{"type":"text","content":"Patient screening underway in Ntrust-1, the first U.S.-based clinical trial of an engineered NK cell therapy for the treatment of lupus nephritis IND cleared for Ntrust-2, a clinical trial for NKX019 for the treatment of systemic sclerosis, myositis and vasculitis Clinical data from Ntrust-1 and Ntrust-2 planned for 2025 SOUTH SAN FRANCISCO, Calif., June 27, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the U.S. Food and Drug Administration (FDA) of its second Investigational New Drug (IND) application for NKX019 in autoimmune disease. With this new IND, Nkarta plans to initiate Ntrust-2, an open-label, multi-center clinical trial of NKX019 for the treatment of systemic sclerosis (SSc, scleroderma), idiopathic inflammatory myopathy (IIM, myositis) and ANCA-associated vasculitis (AAV). NKX019 is an allogeneic, off-the-shelf, chimeric antigen receptor (CAR) NK-cell therapy candidate engineered to deplete CD19-positive cells in B-cell mediated disease. The approach leverages the potential advantages of NK cell therapy, including fludarabine-free lymphodepletion to reduce toxicity, deep and rapid B-cell depletion, and the added utility of on-demand dosing, including repeated dosing as needed. NKX019 is engineered to exert its biologic activity without the need for antibodies or exogenous cytokines. “The initiation of Ntrust-1 in lupus nephritis and the IND clearance for three additional indications are critical milestones in our mission to improve the accessibility and safety of cell therapy. NKX019 is unencumbered by many of the safety, infrastructure and logistical challenges associated with existing cell therapy approaches,” said Paul J. Hastings, President & CEO of Nkarta. “Many people living with lupus are historically underserved, and our aim is to develop treatments that are broadly accessible and easier to tolerate and administer.” Hastings continued, “Our vision goes beyond lupus nephritis, as the unmet need in autoimmune disease is substantial. The clearance of our second IND in autoimmune disease broadens the development of NKX019 and enables us to...