Loading...Loading...Thursday, in its fourth quarter 2023 earnings release, Nkarta Inc NKTX said it closed patient enrollment in its clinical trial of NKX101 and deprioritized the program as part of a pipeline realignment that directs primary resources to its lead pipeline program, NKX019, for autoimmune disease. This follows a recent review of preliminary safety and response data from patients with r/r AML who received NKX101 after lymphodepletion (LD) comprising fludarabine and cytarabine (flu/Ara-C). The aggregate CR/CRi rate (5 of 20 patients) was lower than observed in the first six patients in the cohort. The safety profile of NKX101 was consistent with previously reported data.In June 2023, Nkarta reported updated clinical data from its Phase 1 clinical trial evaluating NKX101 in patients with relapsed or refractory (r/r) AML. In the first six patients that received NKX101 after flu/Ara-C LD, 4 of 6 achieved CR/CRi as of the data cut-off on June 10, 2023. In a follow-up report on these six patients presented at the annual meeting of the American Society of Hematology, of those patients who achieved CR/CRi, 3 of 4 remained in CR/CRi at four months as of the data cut-off on October 31, 2023.In October 2023, Nkarta announced the expansion of its pipeline to include autoimmune disease following the clearance by the FDA of the IND application for NKX019 in lupus nephritis (LN). Nkarta plans to dose the first patient in the LN study in the first half of 2024.As of December 31, 2023, Nkarta had cash, cash equivalents, and investments of $250.9 million, including restricted cash of $2.7 million, which is expected to fund its current operating plan into 2026.Price Action: NKTX shares are down 29.4% at $9.17 on the last check Friday.Image by PDPics from PixabayLoading...Loa.

正在加载。。。正在加载。。。星期四，在2023年第四季度的收益发布中，Nkarta Inc.NKTX表示，它关闭了NKX101临床试验的患者登记，并将该计划作为管道重组的一部分，将主要资源导向其主要管道计划NKX019，用于治疗自身免疫性疾病。在此之前，最近对r/r AML患者的初步安全性和反应数据进行了回顾，这些患者在包括氟达拉滨和阿糖胞苷（flu/Ara-C）的淋巴清除（LD）后接受了NKX101。总CR/CRi率（20名患者中的5名）低于队列中前6名患者的观察结果。NKX101的安全性与先前报道的数据一致。2023年6月，Nkarta报告了其评估复发或难治性（r/r）AML患者NKX101的1期临床试验的最新临床数据。在flu/Ara-C LD后接受NKX101治疗的前6名患者中，截至2023年6月10日数据截止时，6名患者中有4名达到了CR/CRi。在美国血液学会年会上提交的这6名患者的随访报告中，在2023年10月31日数据截止时，4名患者中有3名在CR/CRi中保留了4个月。2023年10月，Nkarta宣布在FDA批准狼疮性肾炎（LN）NKX019的IND申请后，扩大其管道以包括自身免疫性疾病。Nkarta计划在2024年上半年为LN研究中的第一名患者服用药物。截至2023年12月31日，Nkarta拥有现金、现金等价物和2.509亿美元的投资，其中包括270万美元的限制性现金，预计将为其目前的运营计划提供资金，直至2026年。价格行动：上周五，Nkarta股价下跌29.4%，至9.17美元。来自PixabayLoading的PDPics图像。。。贷款。