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Highlights
- Imugene has received positive feedback from the US FDA for the manufacturing process for azer-cel.
- The improved manufacturing process leads to an increase in robustness, scalability, and consistency.
- Azer-cel complements the onCARlytics platform of the company.
- The pivotal clinical trial is expected to commence in 2024.
Imugene Limited (ASX: IMU) has shared an upbeat update, announcing the US FDA support for the improved manufacturing process for azercabtagene zapreleucel (azer-cel).
Azer-cel is an allogeneic (off the shelf) CD19 CAR T cell therapy, and the process is planned to be deployed in a pivotal clinical trial and potentially for manufacturing of the commercial product.
The improved manufacturing process offers increased robustness, scalability, and consistency.
Currently, azer-cel is being evaluated in a multi-centre Phase 1b clinical trial in patients with acute lymphocytic leukemia (ALL) and non- Hodgkin’s lymphoma (NHL).
IMU highlighted that azer-cel has shown clinically relevant activity within an acceptable safety range. Also, azer-cel has delivered encouraging outcomes in DLBCL patients who relapsed following CAR T.
What’s ahead?
After receiving positive feedback from the FDA, the potential commercial azer-cel product is planned to be examined in the clinic and used in the pivotal clinical trial, which is expected to start in 2024.
Azer-cel is being manufactured at IMU’s GMP manufacturing facility in North Carolina.
The company informed that azer-cel will be combined with onCARlytics, as azer-cel highly complements the latter. The combination will be targeting patients with solid tumours.
IMU shares jump over 3%
Post the update, IMU share price jumped 3.28% to trade at AU$0.063 apiece, at the time of writing on 11 September 2023.