A2 Biotherapeutics, Inc. (A2 Bio) has announced that the U.S. Food and Drug Administration (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.
“Receiving Fast Track designation for A2B543 from the U.S. FDA is a key milestone for A2 Bio in accelerating this promising precision CAR T-cell therapy for cancer patients,” said Jim Robinson, chief executive officer of A2 Bio.
“We are deeply committed to patients facing cancer and other devastating diseases, and we believe in the potential for A2B543 to address unmet needs in cancer therapy.”
A2B543 is being investigated in the ongoing 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.
A2B543 is comprised of autologous Tmod cells expressing a MSLN-targeted CAR activator, an HLA-A*02-targeted blocker, and an inducible, membrane-tethered IL-12 (mem-IL-12) booster. The inducible mem-IL-12 booster, which activates only upon engagement with tumour antigens, is designed to enhance the long-term potency and persistence of Tmod while reducing toxicity associated with systemic IL-12.
The A2 Bio Tmod technology platform provides selective killing of tumour cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumour cells and a blocker that protects normal cells. This novel blocker technology enables precise, personalised, and effective T-cell targeting specifically against tumours.