Australian clinical-stage immuno-oncology company Imugene (ASX:IMU) has announced that the US 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 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. Benefits of this designation include more frequent meetings with the FDA to discuss development plans, the option for rolling review of regulatory submissions, and potential eligibility for Accelerated Approval and Priority Review upon meeting relevant criteria.
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.
Imugene said clinical data from the ongoing Phase 1b trial has demonstrated promise to date, 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.
Leslie Chong, the CEO and managing director of Imugene, said, “Receiving FDA Fast Track Designation is a testament to the transformative potential of azer-cel for patients battling relapsed or refractory DLBCL. We are committed to working closely with the FDA to bring this important therapy to patients as efficiently as possible.”