A biotechnology company focused on genetic medicines, Aera Therapeutics, has announced the nomination of its first development candidate, AERA-109, a targeted in vivo CAR-T therapy for B cell-mediated autoimmune diseases. The company presented preclinical data at the 10th Annual CAR-TCR Summit to support this nomination.

The data, gathered from humanized mouse models and non-human primates, demonstrated that AERA-109 was able to generate highly specific and dose-dependent CAR-T cells, leading to a deep depletion of B cells in both the blood and tissues.

AERA-109 leverages Aera’s proprietary targeted lipid nanoparticle (tLNP) delivery platform and CAR-T technology. This innovative approach allows for the direct reprogramming of immune cells inside the body, which could offer a transformative and potentially safer way to treat serious autoimmune conditions. According to company executives, this in vivo generation of CAR-T cells addresses many of the logistical, safety, and scalability challenges associated with traditional ex vivo cell therapies. Specifically, it eliminates the need for lymphodepletion, complex manufacturing processes, or the use of viral vectors that carry the risk of insertional mutagenesis. The company also highlighted a one-step formulation process for the targeted LNP, which does not require a separate conjugation step to incorporate a targeting ligand. Aera Therapeutics plans to advance AERA-109 into clinical development in mid-2026. The company, headquartered in Cambridge, MA, has raised $193 million to date from leading life sciences investors.