Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE)

Core Viewpoint - Fate Therapeutics has received RMAT designation from the FDA for its investigational iPSC-derived CAR T-cell therapy, FT819, aimed at treating moderate to severe systemic lupus erythematosus (SLE) [1][2][3] Group 1: RMAT Designation and Its Implications - The RMAT designation acknowledges the potential of FT819 to meet the significant unmet needs of lupus patients and facilitates increased communication with the FDA during development [2][6] - The designation allows for early interactions with the FDA, including discussions on potential surrogate endpoints for accelerated approval [3][6] Group 2: Clinical Development of FT819 - FT819 is currently in Phase 1 clinical trials, focusing on safety and efficacy with a fludarabine-free conditioning regimen [2][6] - The ongoing study includes dose expansion to 10 patients at 360 million cells and safety assessments at 900 million cells [2] - Additional clinical data from the Phase 1 study is expected to be presented at scientific meetings later in 2025 [2][6] Group 3: Company Overview and iPSC Product Platform - Fate Therapeutics specializes in developing iPSC-derived cellular immunotherapies and has established a leadership position in creating multiplexed-engineered master iPSC lines [4][5] - The company's iPSC product platform is designed to produce uniform, off-the-shelf cell products that can be stored and administered in combination with other therapies [4][5] - Fate Therapeutics holds an extensive intellectual property portfolio with over 500 issued patents and 500 pending applications [4]