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 Pixabay
