CAR-T and orthogonal IL-2 therapy for lupus fast-tracked by FDA
The US Food and Drug Administration (FDA) has granted fast track designation to SYNCAR-001 + STK-009.
The treatment is indicated for patients with severe, refractory systemic lupus erythematosus (SLE), without the use of lymphodepletion.
The fast-track designation follows investigational new drug (IND) clearance for a Phase I study evaluating SYNCAR-001 + STK-009 for non-renal SLE and lupus nephritis (LN).
SYNCAR-001 + STK-009 is a cytokine-inducible, two-component therapy consisting of SYNCAR-001, an autologous CD19-targeting CAR-T which expresses an engineered IL-2 receptor allowing it to selectively receive a signal from STK-009, an engineered IL-2 cytokine.
SYNCAR-001 + STK-009 has been administered to patients with CD19+ haematologic malignancies in an ongoing Phase I study.
“Recent clinical studies have shown CD19 targeted cell therapies can be a potentially effective treatment option for SLE. However, these therapies typically require lymphodepleting chemotherapy that introduce a wide range of toxicities, including cytopenias and infections, for this patient population,” said Debanjan Ray, Chief Executive Officer of Synthekine. “Eliminating lymphodepletion and its associated risks opens the door to a broader population of patients with lupus and other autoimmune diseases, and we look forward to accelerating our efforts to bringing SYNCAR-001 + STK-009 to those individuals in need.”
In the upcoming clinical trial, patients will be treated with a one-time, fixed dose of SYNCAR-001 cells and a defined course of STK-009 via weekly subcutaneous injection.
Fast Track designation is intended to aid the development and expedite the review of drugs to treat serious and life-threatening conditions with unmet medical needs, with the goal of reaching patients earlier. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate’s clinical trial designs and development plans.
Diana Spencer, Senior Digital Content Editor, DDW