AbbVie and Capstan Therapeutics, a clinical-stage biotechnology company, have signed a definitive agreement under which AbbVie will acquire Capstan, including its lead asset, CPTX2309, a potential first-in-class in vivo targeted lipid nanoparticle (tLNP) anti-CD19 CAR-T therapy candidate currently in Phase 1* clinical development (NCT06917742) for the treatment of B-cell-mediated autoimmune diseases. In addition, AbbVie will acquire Capstan’s proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.
The acquisition strengthens AbbVie’s commitment to transforming the future of patient care.
“Scientific innovation is required to address not just the symptoms of autoimmune diseases, but also to resolve and potentially cure the underlying disease,” said Roopal Thakkar, MD, executive vice president, research and development, and chief scientific officer, AbbVie.
“By advancing CPTX2309 and utilizing Capstan’s novel platform technology, AbbVie and Capstan aim to transform the care of those living with autoimmune diseases by developing treatments that have the potential to reset the immune system,” Thakkar added.
Transformative power of cell therapy
“In vivo CAR T-cell therapeutics represent a potential new treatment modality in medicine – embodying the transformative power of cell therapy with the accessibility and scalability of an off-the-shelf biologic. This technology has the potential to become a first-in-class platform to treat a wide range of autoimmune diseases,” said Laura Shawver, Ph.D., president and chief executive officer, Capstan.
“Through AbbVie’s world-leading expertise in immunology research, clinical development, and its commercialization capabilities, we believe that this transaction moves us closer to delivering on our shared mission to bring these innovative therapies to patients in need,” Shawver added.
No complex manufacturing
B cells contribute to the pathogenesis of autoimmune diseases. CD19 is a cell-surface receptor expressed on B cells and is a clinically validated target for ex vivo CAR-T cell therapy to deplete B cells in autoimmune diseases. CPTX2309, developed using Capstan’s proprietary technology platform, which includes hepatic de-targeting, delivers an mRNA payload encoding an anti-CD19 chimeric antigen receptor (CAR) and preferentially reprograms CD8-expressing cytotoxic T-cells.
This process is achieved in vivo, without the need for lymphodepletion preconditioning and complex ex vivo manufacturing.** The in vivo-modified CD8-expressing T cells will transiently express the CD19 CAR and deplete B cells in the periphery and tissues. Depletion of autoreactive antibody-producing pathogenic memory B cells and repopulation with naïve B cells, resulting in immune reset, has the potential to prevent disease progression and induce clinical remission.
Terms of the contract
Under the terms of the agreement, AbbVie will pay up to $2.1 billion in cash at closing to acquire Capstan, subject to specific customary adjustments. The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
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Note: * The phase 1 study is a first-in-human Phase 1, open-label study to evaluate the safety and tolerability of a single ascending dose (SAD) and multiple ascending dose (MAD) of CPTX2309 intravenously administered to healthy adult participants.
** Chimeric Antigen Receptor (CAR) T-cell therapy has emerged as a ground-breaking immunotherapeutic approach. In developing CAR T-cell therapies, immune cells are typically collected and sent to the laboratory; after several steps, these cells are modified to express the CAR gene before being reinfused into the patient. However, this process is complex and expensive. To overcome the complexity of production and the high manufacturing costs associated with current ex vivo CAR T-cell therapy products, scientists have been developing alternative strategies to produce CAR T cells directly in the body in recent years.[1][2]
Clinical trials
A Study of CPTX2309 in Healthy Participants – ClinicalTrials.gov ID NCT06917742.
Reference
[1] Bui TA, Mei H, Sang R, Ortega DG, Deng W. Advancements and challenges in developing in vivo CAR T cell therapies for cancer treatment. EBioMedicine. 2024 Aug;106:105266. doi: 10.1016/j.ebiom.2024.105266. Epub 2024 Aug 1. PMID: 39094262; PMCID: PMC11345408.
[2] Esmaeilzadeh A, Hadiloo K, Yaghoubi S, Makoui MH, Mostanadi P. State of the art in CAR-based therapy: In vivo CAR production as a revolution in cell-based cancer treatment. Cell Oncol (Dordr). 2025 Aug;48(4):859-883. doi: 10.1007/s13402-025-01056-7. Epub 2025 Apr 22. PMID: 40261561; PMCID: PMC12238164.
Featured image: AbbVie Exhibition booth, ASH 2018. Photo courtesy © 2018 – 2025 Sunvalley Communication. Used with permission.
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