AERA-109

AERA-109 is a targeted in vivo CAR-T therapy being developed for the treatment of B cell-mediated autoimmune diseases. Unlike traditional CAR-T therapies that require collecting, modifying, and reinfusing patient T cells ex vivo, AERA-109 uses a proprietary targeted lipid nanoparticle (tLNP) delivery platform to deliver genetic instructions directly into immune cells inside the patient. This generates CAR-T cells in vivo, resulting in dose-dependent CAR-T cell production and deep B cell depletion in preclinical models. The therapy aims to avoid the logistical, safety, and manufacturing challenges of conventional CAR-T approaches and does not require lymphodepletion, viral vectors, or complex manufacturing. Preclinical data show deep B cell depletion in blood and tissues of humanized mouse models and non-human primates. Clinical trials are expected to begin in mid-2026.