CAMBRIDGE, Massachusetts — Aera Therapeutics will present new preclinical data on AERA-109, its targeted in vivo CAR-T therapy candidate for B cell-mediated autoimmune diseases, at the 67th American Society of Hematology Annual Meeting and Exposition, taking place December 6–9, 2025, in Orlando, Florida.
AERA-109 is designed to generate CAR-T cells directly within the body using Aera’s proprietary targeted lipid nanoparticle delivery platform. The therapy aims to achieve deep and sustained B cell depletion across both peripheral blood and B cell-rich tissues. According to the company, the preclinical data being shared at ASH demonstrate potent and durable B cell reduction in non-human primates at doses as low as 0.3 mg/kg, including in the spleen, bone marrow, and lymph nodes.
“We are excited to present preclinical data on our lead program, AERA-109, at ASH which demonstrate the generation of potent CAR-T cells in vivo, driving deep B cell depletion without the need for preconditioning required with ex vivo approaches,” said Bill Querbes, Ph.D., chief scientific officer of Aera Therapeutics. “Importantly, a single dosing cycle mediates deep B cell depletion not just in the periphery, but also in tissues, including the spleen and lymph nodes, which is thought to be critical for immune reset in autoimmune disease. We are excited to advance AERA-109 as a next-generation treatment for patients with B cell-mediated autoimmune diseases and expect to enter clinical development in mid-2026.”
Aera describes AERA-109 as a next-generation approach that could streamline CAR-T treatment by removing the need for cell collection, engineering, and preconditioning typically required in ex vivo CAR-T manufacturing. The upcoming ASH presentation marks an early milestone as the company prepares the program for clinical entry next year.
