Nkarta sinks after sidelining cancer cell therapy in favour of lupus focus
2024-03-22
细胞疗法临床结果临床1期免疫疗法基因疗法
While the potential for cell therapies to treat autoimmune diseases has seen growing excitement – and evidence – this year, Nkarta’s move to deprioritise two cancer programmes and refocus on autoimmune diseases wasn’t met with enthusiasm from investors Friday, as the company’s shares sank 31%.
During its quarterly earnings presentation, Nkarta disclosed updates on its two clinical allogeneic CAR-NK cell therapy programmes; it is no longer enrolling patients to receive NKX101, and the development of NKX019 in cancer hinges on a recently launched compressed dosing cohort. The former is directed against NKG2D, while the latter targets CD19.
Instead, Nkarta will “direct primary resources” to the development of NKX019 for autoimmune diseases. The company plans to dose the first patient with lupus nephritis (LN) in an open-label, dose-escalation trial this half.
NK cell therapies were originally pursued because of their potential for better safety and more convenient administration than T-cell therapies, but the modality has yet to live up to expectations in cancer. Now, some cell therapy developers are hoping to find more success in autoimmune diseases, particularly lupus, which has proven to be an exceptionally difficult disease for drugmakers to address given its complex pathogenesis involving multiple organs and a highly heterogeneous patient population. For more, see Spotlight On: NK cells find new life in autoimmune disease.
Response rate slip
The deprioritisation of the Phase I NKX101 programme comes after Nkarta was unable to replicate early efficacy in more patients with acute myeloid leukaemia (AML).
After initially achieving a complete response (CR) in three of five patients who had received the highest dose of the cell therapy, only one of the next 13 patients to receive NKX101 achieved a CR. Moreover, two of the three initial CR patients relapsed within about two months and have since died, while the third underwent a transplant.
“We see promise in NKX101, but before pursuing further development or significant investment, we will evaluate options for optimising future study design, dosing schedule and manufacturing,” CEO Paul Hastings said.
Meanwhile, Nkarta said development of NKX019 to treat non-Hodgkin’s lymphoma (NHL) will “be contingent on favourable outcomes from the compressed dosing cohort,” which began enrolling in October and is expected to read out mid-year.
Under the new dosing schedule, NKX019 will be administered on days 0, 3, and 7 following standard lymphodepletion with fludarabine and cyclophosphamide, rather than the regimen on days 0, 7 and 14 that previous cohorts received.
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