Novartis $7.8 Billion Abogen Bet Rests on Efficacy Data From Three Patients
Abogen Biosciences announced on 2 October that Novartis will take an exclusive worldwide licence to ABO2203, an mRNA-encoded CD19xCD3 T-cell engager, plus options on a number of unnamed assets from Abogen’s RNA platform. The patient’s own cells make the engager from the injected mRNA. In an investigator-initiated study at Ruijin Hospital published in Cell, three patients with refractory secondary immune thrombocytopenia achieved complete B-cell depletion and complete platelet responses that held through six months, with no cytokine release syndrome. The deal comes weeks after Novartis halted its autoimmune CAR-T, rapcabtagene autoleucel, across eight studies following three deaths.
Novartis has told the field what it now prices highest in autoimmune B-cell depletion: control. A month after three deaths halted rap-cel, it paid $575 million in cash for an engager made only while dosing continues, given weekly by subcutaneous injection with no lymphodepletion or premedication. Every autoimmune cell therapy sponsor will now be measured against that profile.
- Autologous CD19 CAR-T sponsors: the safety benchmark is now an injection. Partners can point to 16 autoimmune patients dosed with every adverse event at grade 1 or 2. Expect diligence to centre on hyperinflammatory events and how cell expansion is controlled.
- In vivo CAR-T and protein engager developers: ABO2203 now sits between them. It needs no cell engineering, and the Cell authors report about four months of B-cell aplasia against roughly one month for blinatumomab in autoimmune use. The counter-argument is durability, since the same authors flag possible re-dosing once B cells return.
- Anyone tracking Novartis: three signposts matter more than the $7.2 billion. That figure includes options on unnamed programmes, and the upfront is 7.4% of the headline. Watch where the first Novartis-sponsored trial runs, what the 13 lupus, rheumatoid arthritis and systemic sclerosis patients already dosed show, and whether rap-cel restarts.