Imugene welcomes positive FDA feedback on new manufacturing process for azer-cel
September 11, 2023 at 02:31 pm EDT
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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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Imugene Limited is a clinical-stage immune-oncology company. It is engaged in developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumors. Its platform technology seeks to harness and promote the bodyâs immune system against cancerous tumors. Its product pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug Azer-Cel (azercabtagene zapreleucel) which targets CD19 to attack blood cancer. Its pipeline includes an Oncolytic Virus and B-Cell Immunotherapies aimed at treating a variety of cancers in combination with standard of care drugs and immunotherapies. Its lead candidate is a chimeric vaccinia (pox) virus known as CF33, which is a combination of genomic sequences from multiple vaccinia virus strains to generate a new, safer and more potent virus. Its Chimeric antigen receptor (CAR)-engineered T cells (CAR T) are T cells redirected against tumors through engineered expression of CARs.