Fate Therapeutics' Lupus Candidate FT819 Gets FDA RMAT Tag

Core Insights - Fate Therapeutics has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for its investigational candidate FT819, aimed at treating active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis [1][3] Company Developments - FT819 is an off-the-shelf, iPSC-derived CAR T-cell product candidate featuring CD8αβ+ T cells with a memory phenotype and high CXCR4 expression, which enhances tissue trafficking [3] - The RMAT designation allows for increased interactions with FDA officials and facilitates accelerated approval processes for FT819 [2] - The company is currently in early-stage development for FT819, having initiated dose expansion in up to 10 patients at 360 million cells based on initial clinical data [5] - The ongoing phase I study is evaluating the safety and efficacy of a fludarabine-free conditioning regimen, using either bendamustine or cyclophosphamide, followed by a single dose of FT819 [6] - As of December 4, 2024, no dose-limiting toxicities or severe adverse events have been observed in the initial patient cohort [9] Market Performance - Year to date, Fate Therapeutics shares have declined by 44%, contrasting with a 9% decline in the broader industry [4]