NKTX - Nkarta Receives FDA Clearance of IND Application for NKX019 in Lupus Nephritis | Benzinga
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 severe manifestations of SLE. Approximately 40 percent of the estimated 200,000 patients in the U.S. diagnosed with SLE will develop LN. Up to 30 percent of patients with LN progress to end stage kidney disease, which can be fatal unless dialysis or a kidney transplant is received.(1)
The multi-center, open label, dose escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory LN. Patients will receive a three-dose cycle of NKX019 at 1 billion or 1.5 billion cells per dose on Days 0, 7 and 14 following lymphodepletion (LD) with single agent cyclophosphamide (cy), an agent with an established safety profile in SLE and LN. The study is designed to enroll up to 12 patients, with the first patient expected to be enrolled in the first half of 2024.
"The potential of cell therapy to reset the immune system and provide long-term, drug-free remissions for patients with severe autoimmune disease may represent the biggest medical breakthrough in the last 50 years of rheumatology," said Roberto Caricchio, M.D., the Myles J. McDonough Chair in Rheumatology, Professor of Medicine, and Chief of the Division of Rheumatology in the Department of Medicine at the University of Massachusetts Chan Medical School. "Patients with lupus nephritis have limited treatment options, and the early results with cell therapy suggest that we may be defining a new era of treatment."
Corporate Updates
Nkarta also announced cost containment measures designed to extend its projected cash runway by one year into 2026, funding its operations well beyond the multiple clinical data updates expected in 2024. Nkarta estimates that, as of September 30, 2023, it had cash, cash equivalents, restricted cash, and investments of $278.4 million. This figure is preliminary and subject to completion of Nkarta's financial closing procedures. The decrease in forecasted spend includes a reduction in and re-allocation of ...