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Nkarta Receives FDA Clearance of IND Application for NKX019 in Lupus Nephritis
New pipeline program builds on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy NKX019,
About this update from Nkarta, Inc.
[{"type":"text","content":"New pipeline program builds on academic studies of durable, drug-free remissions in patients with autoimmune disease after CD19-targeted cell therapy NKX019, an allogeneic CAR NK cell therapy targeting CD19+ B cells, could modify refractory autoimmune disease while maintaining NK-driven safety profile Off-the-shelf accessibility and proprietary engineering could eliminate burdens of autologous products and may enable differentiating conditioning regimen Resource prioritization and cost reductions expected to extend cash runway by one year into 2026 to support important clinical data readouts in 2024 Estimated cash and cash equivalents of $278.4 million as of September 30, 2023 Conference call scheduled for today, October 17, 8:00 am ET SOUTH SAN FRANCISCO, Calif., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the clearance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to evaluate NKX019, its allogeneic, CD19-directed CAR NK cell therapy candidate, for the treatment of lupus nephritis. “We believe that NKX019, as an NK cell-based approach, has the potential to distinguish itself in the growing field of cell therapy for autoimmune diseases through improved access and tolerability. Off-the-shelf availability reduces patient burden and eliminates the need for costly infrastructure and treatment delays required for autologous cell therapies. Our proprietary engineering may also improve safety through a reduced need for lymphodepletion. NKX019 is active immediately and is self-sustaining, without the need for large cytokine surges from preparative chemotherapy,” noted David R. Shook, M.D., Chief Medical Officer of Nkarta. “Patients with severe autoimmune diseases such as lupus nephritis need safe and novel therapies. We will continue to work closely with leading investigators to bring the promise of cell therapy to patients in need to explore this potentially transformative therapeutic approach.” Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by abnormal B cell function and autoantibody production and results in a range of clinical manifestations including organ damage and an increased risk of death. Lupus nephritis (LN) is among the most sev...