Regulatory Nkarta's Landmark FDA Approval Propels Expansion of Cell Therapy...

Nkarta’s Landmark FDA Approval Propels Expansion of Cell Therapy into Lupus Treatment


Nkarta has achieved a significant milestone by securing FDA approval to broaden the scope of cell therapy, reaching beyond its traditional domain in cancer treatment. This regulatory green light has paved the way for human trials of a CAR NK candidate tailored for lupus. 

Nkarta publicly disclosed that the FDA had granted the company permission to initiate human trials for NKX019 in lupus nephritis. This announcement catalyzed a substantial increase in Nkarta’s stock price, which soared from $1.47 per share at the market’s opening to $3.14 by the close of the trading day. Their allogeneic CAR NK cell therapy candidate, which specifically targets CD19, is currently in the midst of a phase 1 clinical trial for patients afflicted by B-cell malignancies. The release of top-line data from this trial is eagerly anticipated in the coming year.

With this announcement, Nkarta has embarked on a corporate restructuring initiative that includes a reduction in its workforce. According to documents filed with the Securities and Exchange Commission (SEC) on October 16, the company is poised to terminate the employment of 18 individuals.

This groundbreaking shift towards applying cell therapy in conditions other than cancer is underpinned by a noteworthy German study featuring five patients diagnosed with systemic lupus erythematosus (SLE) who underwent CAR-T cell therapy. Published in Nature Medicine last year, this study unveiled the remarkable finding that all five patients achieved remission within a three-month timeframe, a remission that persisted even after the re-emergence of B cells more than three months later.

Nkarta’s forthcoming trial will take the form of a multicenter, open-label, dose-escalation study involving patients grappling with refractory lupus nephritis. In this trial, patients will receive three doses of NKX019 administered on three separate occasions, with one week separating each dose. The treatment regimen commences after lymphodepletion with cyclophosphamide, an immunosuppressive drug well-known for its safety record in lupus and its application in chemotherapy. The trial is anticipated to encompass a maximum of 12 patients, and the initiation of the first patient’s participation is scheduled for the first half of 2024.

To accelerate the advancement of NKX019, Nkarta has established a strategic partnership with Lupus Therapeutics, which serves as a clinical research affiliate of the Lupus Research Alliance.

Presently, the armamentarium for lupus treatment encompasses GSK’s SLE drug Benlysta, a biologic therapy that secured FDA approval in 2011 and recorded over $1 billion in revenue last year. Another treatment option is AstraZeneca’s Saphnelo, an intravenous infusion that received approval for SLE patients in 2021.

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