Novartis-Abogen Deal & Background
Novartis has agreed to pay Abogen Biosciences $575 million up front for an mRNA-encoded T-cell engager (TCE) that demonstrated early clinical potential in the treatment of autoimmune diseases.
The agreement, which includes up to $7.2 billion in milestones, follows a respite in a CAR-T autoimmune program by Novartis due to three deaths.
The success of CD19 CAR-T cell therapies in difficult-to-treat autoimmune disorders has given impetus to research. In addition to testing off-the-shelf cell therapies, companies are working on in vivo CAR-Ts and bispecific TCEs, engineered to do the same thing (kill B cells) in a different way. Another spin-off on this concept is Abogen’s ABO2203.
Mechanism & Early Clinical Promise
The drug candidate is an mRNA encoding a CD19xCD3 TCE formulated in a lipid nanoparticle (LNP). Once injected, the patient’s cells will make the TCE under the direction of the mRNA. The aim is similar to CAR-Ts and conventional recombinant TCEs, which aim to kill B cells that promote autoimmunity. But making the TCE in the body, rather than in a factory, could have benefits.
Recently, Abogen released data that demonstrated ABO2203 was able to reduce B cells in three patients with immune thrombocytopenia (ITP) without causing cytokine release syndrome. With a blood cancer trial providing additional evidence of ABO2203’s pharmacokinetics and safety, Novartis has signed off on a deal for the asset.
Under the deal, Novartis acquires global development and commercialisation rights for ABO2203, and an exclusive option to develop “a number” of future therapeutics based on Abogen’s RNA platform. ABO2203 is expected to be accelerated by the collaboration with Novartis and open new therapeutic options, said Abogen’s CEO Bo Ying in a statement.
Trial Scope, Safety Profile & Key Advantages
Abogen partner Ruijin Hospital began a phase 1 autoimmune disease trial of ABO2203 in 2024. A year ago, the hospital began a trial of ABO2203 for B-cell non-Hodgkin’s lymphoma patients. The asset has potential in both, but the autoimmune disease is the focus of Abogen and Novartis’s press release.
The mechanism of targeting CD19 and CD3 has been successfully used in the treatment of blood cancer with Amgen’s Blincyto, and the target is currently being used in many other trials. In certain autoimmune diseases, however, the advantages of mRNA-based therapy might be more significant. The in vivo production of TCEs will result in a slow release and systemically timed exposure to the drug, which would otherwise be associated with toxicities at high concentrations.
According to the researchers who published the ITP data, researchers believe that ABO2203 could be administered as a subcutaneous injection without lymphodepletion or premedication and would cost less than in vivo CAR-T. The ITP results demonstrated the rapid and complete depletion of CD19+ B cells from peripheral blood and bone marrow with complete platelet responses.
Abogen Biosciences has entered a major licensing and option agreement with Novartis that could be worth approximately $7.8 billion, marking a significant deal for the Chinese biotechnology company and its RNA technology platform. The agreement centers on ABO2203, an investigational mRNA-encoded CD19xCD3 T-cell engager being developed for autoimmune diseases. Abogenbio
Abogen Secures $575 Million Upfront
The transaction reflects the pharmaceutical industry’s growing interest in in vivo immune-cell engineering, an approach that could simplify the delivery of complex biologic therapies. Rather than producing a therapeutic protein outside the body and repeatedly administering it, the technology is designed to use messenger RNA to temporarily direct cells to produce the desired molecule.
The autoimmune field has become an increasingly important area for next-generation immune therapies. B cells are involved in the development of numerous autoimmune disorders, making targeted B-cell depletion an attractive strategy for researchers seeking deeper and potentially longer-lasting disease control.
The program’s use of an mRNA delivery system could also provide flexibility in how treatment is administered. Lipid nanoparticles can transport genetic instructions into cells, where the mRNA can then be translated into the therapeutic protein. Because mRNA is temporary, the approach is intended to provide controlled, transient production rather than permanent genetic modification.
The partnership could also expand development opportunities beyond the lead program. Access to additional candidates generated through the underlying technology platform gives the pharmaceutical partner the possibility of building a broader pipeline around in vivo protein production and immune-cell engagement.
