Novartis is paying Abogen Biosciences $575 million upfront for an mRNA-encoded T-cell engager (TCE) that showed early clinical promise in autoimmune disease.
The deal, which includes up to $7.2 billion in milestones, comes weeks after Novartis paused an autoimmune CAR-T program over three deaths.
Evidence that CD19 CAR-T cell therapies improve outcomes in hard-to-treat autoimmune diseases has spurred a wave of research. As well as testing conventional cell therapies, companies are studying in vivo CAR-Ts and bispecific TCEs designed to achieve the same goal—deplete B cells—by different means. Abogen’s ABO2203 is another twist on the idea.
The drug candidate is a lipid nanoparticle-formulated mRNA encoding a CD19xCD3 TCE. After being injected, the mRNA directs the patient’s cells to produce the TCE. As with CAR-Ts and traditional recombinant TCEs, the goal is to deplete the B cells that drive autoimmune disease. But making the TCE in the body, rather than in a factory, could have benefits.
China-based Abogen recently published data showing ABO2203 depleted B cells in three immune thrombocytopenia (ITP) patients 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.
The agreement gives Novartis global rights to ABO2203, plus an exclusive option to license “a number” of next-generation therapeutic assets developed on Abogen’s RNA platform. Partnering with Novartis will accelerate ABO2203 and unlock new therapeutic targets, Abogen CEO Bo Ying said in a statement.
Abogen partner Ruijin Hospital began a phase 1 autoimmune disease trial of ABO2203 in 2024. The hospital started testing ABO2203 in B-cell non-Hodgkin lymphoma patients last year. While the asset showed promise in both settings, Abogen and Novartis’ press release focuses on autoimmune disease.
Engaging CD19 and CD3 to treat blood cancer is a proven mechanism, pioneered by Amgen’s Blincyto. But the benefits of an mRNA-based approach may be more pronounced in autoimmune disease. Making TCEs in vivo provides gradual systemic exposure, avoiding toxicities caused by high drug concentrations.
ABO2203 could be given in outpatient settings as a subcutaneous injection without lymphodepletion or premedication and cost less than in vivo CAR-T, according to researchers who published the ITP data. The ITP results showed rapid, complete depletion of CD19-positive B cells in peripheral blood and bone marrow, as well as complete platelet responses.
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