Imugene welcomes positive FDA feedback on new manufacturing process for azer-cel
Melbourne, Victoria
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September 11, 2023 02:30 PM Eastern Daylight Time
Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) MD Leslie Chong tells Proactive the company has received positive FDA feedback on an improved manufacturing process for azer-cel, an off the shelf CD19 CAR T cell therapy for blood cancers. She says the improved manufacturing process allows for increased robustness, consistency and scalability with a pivotal study potentially to start in 2024. If approved, it’ll become the first allogeneic CAR T cell therapy for cancer.
“Azer-cel has the potential to be the first CD19-directed allogeneic cell therapy and having the FDA support on the manufacturing process that can be used for the pivotal trial is an extremely important milestone for Imugene as it improves the overall robustness and scalability of the product,” Chong said.
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