CAMBRIDGE, Mass.– Aera Therapeutics said Wednesday it has nominated AERA-109, a targeted in vivo CAR-T therapy for B cell-mediated autoimmune diseases, as its first development candidate. The announcement follows the company’s presentation of preclinical data at the 10th Annual CAR-TCR Summit.
In humanized mouse models and non-human primates, AERA-109 demonstrated strong activity, showing deep depletion of B cells in blood and tissues. The therapy uses Aera’s proprietary targeted lipid nanoparticle (tLNP) delivery platform and CAR-T technology to reprogram immune cells directly in the body, offering an alternative to conventional ex vivo approaches.
“The nomination of AERA-109 as our first development candidate represents a major step forward for Aera and is a compelling demonstration of our delivery-first approach to significantly expand the reach of genetic-based medicines,” said Akin Akinc, Ph.D., chief executive officer of Aera Therapeutics. “By enabling in vivo generation of CAR-T cells with precise tissue targeting, AERA-109 has the potential to address many of the logistical, safety, and scalability challenges of traditional ex vivo cell therapies. We are very encouraged by the deep B cell depletion we observed in non-human primates, and we look forward to advancing this program into the clinic in mid-2026.”
Bill Querbes, Ph.D., chief scientific officer of Aera, said the candidate underscores the potential of combining delivery innovation with therapeutic design. “AERA-109 is a powerful example of what’s possible when cutting-edge delivery intersects with bold therapeutic design,” he said. “This approach eliminates the need for lymphodepletion, complex manufacturing processes, or use of viral vectors that carry the risk of insertional mutagenesis. We have also developed a formulation process that enables one-step targeted LNP generation that does not require a separate post-formulation conjugation step to incorporate a targeting ligand. We are excited to advance AERA-109 as a next-generation treatment for patients with B cell-mediated autoimmune diseases.”
Aera plans to advance AERA-109 into clinical development in mid-2026.
