(RTTNews) - Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company developing iPSC-derived cellular immunotherapies, announced that the California Institute for Regenerative Medicine (CIRM) awarded the company a $15.0 million CLIN2 grant to support the clinical development of FT819 in lupus nephritis.

The grant will support RECLAIM-LN, a Phase 2, potentially registrational trial evaluating FT819, an off-the-shelf CD19-targeting CAR T-cell therapy, in patients with refractory moderate-to-severe systemic lupus erythematosus with lupus nephritis.

Lupus nephritis is a serious manifestation of systemic lupus erythematosus and a leading cause of kidney failure among people living with lupus.

Fate estimates that approximately 150,000 patients in the U.S. are affected by lupus nephritis.

The RECLAIM-LN study is designed as a multicenter, open-label, single-arm Phase 2 trial and is expected to enroll approximately 53 patients who are refractory to at least two prior systemic immunosuppressive therapies.

The primary endpoint is the proportion of participants achieving a complete renal response at Week 26. Key secondary endpoints include measures of disease activity and quality of life.

Preliminary Phase 1 data showed favorable safety and tolerability, along with improvements in disease activity measures including SLEDAI-2K and urine protein-to-creatinine ratio.

The company also reported further reductions in these measures with less-intensive bendamustine conditioning.

FT819 is being developed as an off-the-shelf CAR T-cell therapy using a precisely engineered clonal induced pluripotent stem cell master bank.

The approach is intended to enable manufacturing, storage and on-demand availability without requiring patient-specific or donor-derived cell collection.

The RECLAIM-LN program was developed through interactions with the FDA under FT819's Regenerative Medicine Advanced Therapy designation.

FT819 has also been selected for the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot program.

Upcoming Milestones Fate Therapeutics plans to advance the RECLAIM-LN Phase 2 trial of FT819 in refractory lupus nephritis. The company expects the $15 million CIRM grant to support continued clinical development of the off-the-shelf CAR T-cell candidate and its potential progression toward a registrational pathway.

FATE has traded between $0.95 and $3.23 over the past year. The stock closed Thursday's trading at $2.33, down 4.12%. In pre-market trading the stock is at $2.44, up 4.72%.