FDA Grants Fast Track Designation to Imugenes Bile Duct Cancer Program

Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, has received Fast Track designation from the US Food and Drug Administration (FDA) for its MAST (Metastatic Advanced Solid Tumours) clinical program. The program assesses the safety and efficacy of the cancer-killing virus CF33-hNIS (VAXINIA) for treating bile duct cancer, a challenging and often unresponsive cancer type.

Fast Track status allows for closer collaboration with the FDA, expediting the clinical program and potential approval process. The benefits include accelerated approval eligibility, priority review, and regular dialogue with the FDA. Imugene aims to leverage this designation to advance the drug program efficiently and potentially provide earlier access to patients. The Phase 1 MAST trial, initiated in May 2022, focuses on patients with metastatic or advanced solid tumors, exploring the efficacy of VAXINIA.

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