AbbVie, a prominent player in the pharmaceutical industry, is making significant strides in the realm of cell therapies for cancer and autoimmune diseases. Although it wasn’t among the pioneers of the initial wave of cell therapies, the company is now strategically positioning itself to lead in the next generation of therapies. This new wave focuses on engineering immune cells directly within a patient’s body, offering a novel approach to treatment. To bolster this strategy, AbbVie is investing up to $2.1 billion to acquire Capstan Therapeutics, a forward-thinking cell therapy startup that is leveraging groundbreaking research from biotechnology experts at the esteemed University of Pennsylvania.
While the specific financial details of this acquisition were not disclosed, the announcement made on Monday highlights that AbbVie is gaining access to Capstan’s leading program, which has recently initiated a Phase 1 clinical trial focused on autoimmune diseases. This acquisition includes CellSeeker, the innovative platform technology responsible for developing this promising therapy, which could significantly enhance AbbVie’s capabilities in the field of immunotherapy.
The pioneering CAR T-therapies that have reached patients are primarily derived from harvesting a patient’s own T cells, which are then modified in a laboratory setting to specifically target certain cancers. After these engineered cells are multiplied, they are reinfused into the patient’s body. However, this process can take several weeks, prompting many companies, including AbbVie, to explore ways to expedite and streamline these treatments. The in vivo engineering of a patient’s immune cells could potentially eliminate the need for the cumbersome and costly multi-step manufacturing process currently required for CAR T-therapy.
Capstan, based in San Diego, employs a cutting-edge method that utilizes messenger RNA (mRNA) to reprogram immune cells, enabling them to target and eliminate disease-causing cells effectively. This mRNA is safely encapsulated within a lipid nanoparticle, which serves as a delivery vehicle. Unlike viral vectors, which are often used for genetic therapies but typically offer only one-time treatments, lipid nanoparticles do not incite a strong immune response. This characteristic allows for potential redosing, which is crucial in treating chronic conditions that require ongoing therapy, thus making it a game-changer in the field of immunology.
AbbVie already boasts a strong portfolio in immunology and inflammation, yet the company is keen on expanding its reach in this sector, especially as its flagship antibody drug, Humira, faces increasing competition from biosimilars. To counteract revenue declines, AbbVie has introduced Skyrizi, another antibody treatment, alongside Rinvoq, an oral small molecule that is gaining traction across multiple immunology indications. The integration of Capstan’s innovative therapies adds a new dimension to AbbVie’s existing immunology pipeline, enhancing its prospects for future growth.
The standout program from Capstan is CPTX2309, designed to treat B cell-mediated autoimmune disorders. This therapy works by targeting and depleting pathogenic memory B cells, which are responsible for chronic autoimmune responses, thereby allowing the immune system to regenerate with naïve B cells that do not attack healthy tissues. This innovative approach has the potential to “reset” the immune system, which could not only halt disease progression but also lead to clinical remission for patients suffering from these conditions.
Recent preclinical findings shared at the annual meeting of the American Society of Cell & Gene Therapy revealed that Capstan’s CAR T-therapy was effective in the in vivo engineering of immune cells, successfully depleting B cells in both blood and tissues. Notably, this therapy does not require lymphodepletion, a process that suppresses the immune system to facilitate the uptake of engineered cells, which is a critical step in traditional ex vivo CAR T-therapies for cancer.
A Phase 1 trial for CPTX2309 is currently in progress, enrolling healthy volunteers to assess both safety and efficacy. The primary objectives include evaluating the therapy’s safety profile and its effectiveness, while secondary goals involve measuring the concentration of CPTX2309 and the levels of circulating B cells in participants. This comprehensive approach will provide valuable insights into the therapy’s mechanisms and outcomes.
According to William Blair analyst Matt Phipps, discussions with AbbVie management revealed promising preliminary data from the Phase 1 study, indicating that “patients achieving rapid and robust B-cell depletion” provide early clinical validation for CPTX2309. Although this program is still in the nascent stages of clinical development, William Blair views the acquisition as a strategic move by AbbVie to fortify its immunology portfolio with innovative, disease-modifying therapies.
“Given the stage of development, this asset clearly comes with clinical risk, but the potential of in vivo CAR-T, which eliminates the need for lymphodepletion and offers greater manufacturing scalability, presents significant long-term benefits if successful,” Phipps noted in his analysis.
Among Capstan’s co-founders are notable figures such as Carl June, a leading immunotherapy professor at Penn, known for developing Kymriah, the first FDA-approved CAR T-therapy under Novartis. Another co-founder is Drew Weissman, a Penn professor specializing in vaccine research and mRNA technology. Founded in 2022, Capstan has successfully raised $165 million to date, with its latest funding round in 2024 securing an additional $175 million in Series B financing. Besides its flagship program for B cell-mediated autoimmune diseases, Capstan is also developing preclinical in vivo CAR T-programs aimed at treating plasma cell disorders and fibrotic diseases.
Several other companies, including Kyverna Therapeutics and Autolus Therapeutics, are also exploring CAR T-therapies for autoimmune diseases, although their approaches involve ex vivo techniques. Clinical-stage startup Umoja Biopharma is pioneering in vivo CAR T-therapies, and last year, AbbVie licensed an Umoja in vivo CAR T-program specifically targeting blood cancers. Additionally, Umoja is developing another in vivo CAR T-program for autoimmune diseases in collaboration with Iaso Biotherapeutics.
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