Imugene thrilled as VAXINIA granted FDA Fast Track designation
November 28, 2023 at 01:31 pm EST
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Imugene Ltd (ASX:IMU, OTC:IUGNF) CEO Leslie Chong and chief medical officer Dr Paul Woodard speak with Proactive following the news it’s been granted 'Fast Track' designation from the US Food and Drug Administration (FDA) for its MAST (metastatic advanced solid tumours) clinical program — evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA). The FDA’s Fast Track designation is awarded to help important new therapies reach patients earlier. It is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.
“The Fast Track process of drug development is designed to facilitate the development, and the review of drugs to treat serious conditions and fill an unmet medical need, with fast track status often leading to earlier drug approval and access by patients,” 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.