Posted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous CAR T-cell therapy designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumours that express MSLN and have lost HLA-A*02 expression.
A2B543 is being investigated in the on-going EVEREST-2 clinical study which is evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2) autologous logic-gated investigational cell therapies in patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumours that express MSLN and have lost HLA-A*02 expression.
