Aera Therapeutics Presents Preclinical Data and Announces Nomination of First Development Candidate, AERA-109, a Targeted In Vivo CAR-T Therapy for B Cell-mediated Autoimmune Diseases

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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep 24, 2025--

Aera Therapeutics, a biotechnology company harnessing next-generation enabling delivery technologies and precision payloads to unlock the full potential of genetic medicines, today presented preclinical data at the 10 th Annual CAR-TCR Summit supporting the nomination of AERA-109, a targeted in vivo CAR-T therapy designed to treat multiple B cell-mediated autoimmune diseases, as the company’s first development candidate.

Data outlined in the presentation demonstrate an optimized delivery profile with highly specific and dose-dependent CAR-T cell generation, resulting in deep depletion of B cells in blood and tissues in humanized mouse models and non-human primates. AERA-109 leverages Aera’s proprietary targeted lipid nanoparticle (tLNP) delivery platform and CAR-T technology to reprogram immune cells directly inside the body, offering a potentially transformative approach to treating serious autoimmune conditions with greater precision and improved safety.

“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.”

“AERA-109 is a powerful example of what’s possible when cutting-edge delivery intersects with bold therapeutic design,” said Bill Querbes, Ph.D., chief scientific officer of Aera. “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.”

About Aera

Aera Therapeutics is a biotechnology company harnessing next generation enabling delivery technologies and precision payloads to unlock the full potential of genetic medicines. Aera has multiple proprietary delivery platforms including targeted lipid nanoparticles (tLNPs), antibody oligonucleotide conjugates (AOCs), and protein nanoparticles (PNPs), that are being developed to enable next-generation genetic medicines across a range of therapeutic modalities and disease areas. Aera’s vision is to expand the reach of genetic medicines to different tissues and applications, in order to benefit more patients across more disease areas. Aera is headquartered in Cambridge, MA, and has raised $193 million to date from leading life sciences investors. To learn more, please visit www.aeratx.com and follow us on LinkedIn.

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KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS

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SOURCE: Aera Therapeutics

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PUB: 09/24/2025 07:00 AM/DISC: 09/24/2025 06:59 AM

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