A2 Biotherapeutics Receives U.S. FDA Fast Track Designation for A2B543, a Logic-Gated CAR T-Cell Therapy Enhanced with a Membrane-Tethered IL-12 Booster

AGOURA HILLS, Calif.--(BUSINESS WIRE)--A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, today 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 tumors that express MSLN and have lost HLA-A*02 expression.

Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.¹

“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 (NCT06051695) 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 tumors 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 tumor antigens, is designed to enhance the long-term potency and persistence of Tmod™ while reducing toxicity associated with systemic IL-12.²

The A2 Bio proprietary Tmod™ technology platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

About A2 Bio

A2 Biotherapeutics, Inc. (A2 Bio) is a clinical-stage biotech company developing first-in-class logic-gated cell therapies to address the high unmet need in cancers. A2 Bio invented the proprietary Tmod™ cell therapy platform to tackle the fundamental challenge in cancer treatment—the ability of cancer medicines to distinguish between tumor and normal cells. For more information, visit the company’s website at www.a2bio.com.

References

¹ U.S. Food and Drug Administration website accessed March 30, 2026, link https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

² Zhang JA, Imboden S, Lee D, et al. Onboard, tethered IL-12 boosts potency of the Tmod NOT gate and preserves selectivity. J Immunother Cancer. 2025;13(5):e010976. Available at: https://www.a2bio.com/wp-content/uploads/Onboard-tethered-IL-12-boosts-potency-of-the-Tmod-NOT-gate-and-preserves-selectivity.pdf