Fate Therapeutics Moves Lupus Nephritis Therapy Into Phase Two
The cell-therapy developer held $153.8 million in cash and investments and maintained its operating-runway outlook into 2028 after treating its first RECLAIM-LN patient.
Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company, treated the first patient in its potentially registrational Phase 2 lupus nephritis trial, moving its autoimmune program from preparation into dosing. The patient received the off-the-shelf FT819 cell therapy as an outpatient and was discharged the same day.
The milestone extended a progression across the company’s latest updates. In February, Fate reported outpatient treatment in its earlier-stage autoimmune trial while preparing for Phase 2. In May, it said RECLAIM-LN remained on schedule to begin in the second half of 2026. By the August update, the study had begun, with additional patients undergoing screening at activated sites.
RECLAIM-LN is expected to enroll approximately 53 patients with refractory moderate-to-severe lupus nephritis. The open-label, single-arm study was designed to assess one dose of 900 million FT819 cells following bendamustine conditioning, with complete renal response at Week 26 as its primary endpoint. The design put reduced conditioning and outpatient administration into a later-stage test of the company’s approach.
Manufacturing preparations had also moved into supply. Fate had manufactured and released its first pivotal FT819 batch and placed inventory in distribution depots for delivery to participating sites. The company also received authorization to conduct RECLAIM-LN at U.K. sites. Its potency strategy and several other manufacturing-readiness elements had been discussed and aligned with the FDA, with further discussions continuing under the agency’s development-readiness pilot program.
Bendamustine was selected based on the deepest and most durable responses observed with that conditioning regimen in Fate’s Phase 1 lupus study. Among 10 evaluable patients taking background glucocorticoids, seven reached doses of 5 milligrams a day or less, including five who discontinued steroids. Those results accompanied reported improvements in disease activity, kidney, and fatigue measures.
FT819’s systemic sclerosis evidence also gained follow-up. February’s update had highlighted disease improvement in the first patient reaching a three-month assessment; the August release described improvements in skin scores at three months in all four treated patients. Fate reported no cytokine release syndrome or graft-versus-host disease in that group and is exploring accelerated development in the indication.
The company’s next autoimmune candidate crossed a regulatory threshold in July, when the FDA cleared FT839 for clinical testing. The dual-target therapy was engineered against CD19 and CD38. Its COMPLETE Phase 1/2 basket study was designed to evaluate multiple autoimmune diseases alongside background therapy without requiring conditioning chemotherapy. Fate plans to provide an enrollment update later this year.
In oncology, subsequent FT836 development is expected to focus on KRAS wild-type colorectal cancer after preliminary anti-tumor activity was observed in two heavily pretreated patients. Five patients were evaluable for initial efficacy in the reported dataset. Fate plans to combine repeated FT836 dosing with standard chemotherapy in the next cohort and expects its next clinical update in the first half of 2027.
The clinical advances accompanied lower spending. Second-quarter operating expenses were $33.2 million against $38.9 million a year earlier. Research and development accounted for $24.4 million, while general and administrative spending totaled $8.8 million. The net loss narrowed to $30.2 million from $34.1 million.
For the six months ended June 30, operating expenses fell $14.3 million from the corresponding 2025 period. That reduction reflected lower research and development and administrative spending.
Second-quarter revenue was $2.1 million, derived from preclinical work under the Ono Pharmaceutical collaboration. Cash and investments fell $21 million during the quarter to $153.8 million. Resources are expected to fund operations into 2028, reflecting improvements in Fate’s expense structure. The company aims to complete RECLAIM-LN enrollment in the first half of that year.
Stronger demand supports expansion as pricing diverges