NEW YORK – A2 Bio said on Thursday that it has treated the first patient in a Phase I/II trial of its autologous cell therapy A2B694 in mesothelin-expressing solid tumors that have lost HLA-A*02 expression.
The Phase I/II clinical trial, dubbed EVEREST-2, will enroll patients with mesothelioma, colorectal cancer, non-small cell lung cancer, pancreatic cancer, ovarian cancer, and other mesothelin-expressing cancers.
The autologous, logic-gated cell therapy was developed using A2's Tmod platform, which involves engineering cells with a dual-receptor design meant to kill tumor cells with an activator construct while protecting HLA-A*02-presenting normal cells with a blocker action.
In the EVEREST-2 trial, Agoura Hills, California-based A2 seeks to determine its cell therapy's safety and recommended dose.
The firm is also evaluating an autologous CAR T-cell therapy, dubbed A2B530, in patients with non-small cell lung, colorectal, and pancreatic cancers.
Earlier this year, the US Food and Drug Administration granted orphan drug designation to A2B530 for germline heterozygous HLA-A*02-positive colorectal cancer patients whose cancers express the carcinoembryonic antigen (CEO) and have lost their HLA-A*02 expression.