Nkarta, Inc. 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. 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. 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. 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 headcount combined with a stringent cap on future headcount growth, planned centralization of operations to a single location and early success in the optimization of Nkarta?s manufacturing platform.

The company expects to announce clinical updates from its three pipeline programs in 2024: NKX101 (AML) in the first half of 2024, NKX019 (NHL) in mid-2024 and NKX019 (AID) in 2024. Nkarta will evaluate options to advance each program with additional investment on the basis of those data readouts.