Nkarta’s pivot from oncology to autoimmune disease has continued with the biotech halting work on its CD19-directed CAR NK in lymphoma to focus on lupus.
Seven patients with heavily pretreated large B-cell lymphoma (LBCL) that a CD19 CAR-T therapy had not halted had received the asset in question, dubbed NKX019. Of these individuals, five achieved a partial response after the first cycle of treatment, with one of them reporting a complete response with more than six months of durability following a second treatment cycle.
After reflecting on the data, Nkarta CEO Paul Hastings explained that the biotech has decided to “forgo future development” for the therapy in oncology.
“In reviewing the clinical data from the latest cohort of patients with large B-cell lymphoma and the evolving treatment landscape, Nkarta will focus its efforts on autoimmune diseases, where we believe NKX019 has potential to transform patient care,” Hastings added in a third-quarter earnings release Nov. 7.
Those autoimmune ambitions are well underway, with the first patients dosed in two separate trials of different types of lupus in recent months. A trial of NKX019 in systemic sclerosis, myositis and vasculitis is also due to kick off by the end of the year, with initial readouts penciled in for 2025.
William Blair analysts said they were “not surprised” by Nkarta’s move and were “supportive of Nkarta’s decision, as we believe NKX019’s profile is well suited for autoimmune diseases.”
“Although the cell therapy space for lupus is becoming increasingly crowded, we are optimistic about NKX019’s therapeutic potential, given that the company is not including flu in its lymphodepletion regimen, which could promote increased accessibility and tolerability, and NKX019 is allogeneic, which would eliminate the burden of apheresis,” the analysts added in a Nov. 7 note. “In addition, in our view, the safety profile of NKX019 has been favorable to CAR-T cell approaches in the oncology setting.”
The biotech ended September with $405.3 million in cash and equivalents, which it expects to fund operations into late 2027.
Nkarta’s pivot from cancer to autoimmune diseases follows an increasingly well-worn path for cell therapy biotechs, with data suggesting CD19-focused treatments in particular may be effective against lupus.
"We’re encouraged by the early progress that we’ve made in the clinical investigation of NKX019 for autoimmune disease,” Hastings added in the Nov. 7 release. “Safety and accessibility are paramount in autoimmune disease, and we believe that an off-the-shelf, engineered NK cell therapy has the greatest potential to help patients.”
Nkarta’s course toward lupus was set last year and then reaffirmed in March when the company deprioritized a CAR NK candidate after data from 14 patients with acute myeloid leukemia failed to live up to the asset’s initial promise.