• Azer-cel, Imugene's allogeneic CAR T-cell therapy, granted FDA Fast Track Designation for relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
• Fast Track Designation facilitates expedited development and review for therapies addressing serious conditions
• Azer-cel designed to overcome logistical challenges of autologous CAR T therapies, allowing for rapid treatment delivery

Imugene Limited, a clinical-stage immuno-oncology company, has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its allogeneic CAR T-cell therapy, azer-cel (azercabtagene zapreleucel), for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The FDA's Fast Track Designation is designed to facilitate the development and expedite the review of drugs that address serious or life-threatening conditions and meet an unmet medical need. Azer-cel is an off-the-shelf, CD19-directed CAR T-cell therapy engineered to overcome the logistical challenges of autologous CAR T therapies, such as prolonged manufacturing times and limited patient access. By leveraging pre-manufactured donor T-cells, azer-cel allows for rapid treatment delivery. Clinical data from the ongoing Phase 1b trial has demonstrated significant promise, particularly in patients who failed multiple prior therapies including autologous CAR T. The therapy incorporates a novel combination of lymphodepletion chemotherapy and interleukin-2 (IL-2) to enhance CAR T persistence and efficacy, and has shown a manageable safety profile with no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) observed in key patient cohorts.

Imugene is committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible, addressing the critical unmet need for relapsed or refractory DLBCL patients.