Nkarta, Inc. (NASDAQ: NKTX) has recently made significant strides in its clinical trials and pipeline expansion, marking a critical milestone in the development of engineered natural killer (NK) cell therapies. The company has initiated the NTRUST-1 clinical trial of NKX019 in lupus nephritis, with the first patient in screening. Additionally, the U.S. Food and Drug Administration (FDA) has cleared Nkarta's second Investigational New Drug (IND) application for NKX019 in autoimmune disease, leading to the expansion of its pipeline to include 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. It offers advantages such as fludarabine-free lymphodepletion to reduce toxicity, deep and rapid B-cell depletion, and the ability for on-demand dosing, including repeated dosing as needed, without the need for antibodies or exogenous cytokines.
The company's CEO, Paul J. Hastings, emphasized the significance of these developments, noting that NKX019 is unencumbered by many of the safety, infrastructure, and logistical challenges associated with existing cell therapy approaches. The expansion of the IND in autoimmune disease enables Nkarta to evaluate three additional B-cell mediated diseases in parallel.
The NTRUST-1 and NTRUST-2 trials are designed to assess the safety and long-term remission potential of NKX019 in people living with autoimmune diseases. Both trials will involve three-dose cycles of NKX019 at 1 billion or 1.5 billion cells per dose following single-agent lymphodepletion with cyclophosphamide, with plans to enroll up to 12 patients initially.
The expansion of Nkarta's pipeline to include systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis holds promise for the treatment of these conditions, which have limited therapeutic options and significant unmet medical needs.
The approval of the IND and initiation of clinical trials mark significant progress in Nkarta's mission to develop accessible and safe cell therapy treatments for a range of autoimmune diseases, offering hope for patients living with these conditions. Today the company's shares have moved -2.5% to a price of $5.82. Check out the company's full 8-K submission here.
