Imugene (ASX:IMU) secures FDA fast track designation

Imugene Limited (ASX:IMU) has 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). This designation offers closer cooperation with the FDA to expedite the MAST clinical program and subsequent potential approval process, providing eligibility for Accelerated Approval and Priority Review.

Imugene CEO and CMO on FDA fast track designation

Imugene CEO and MD Ms Leslie Chong stated, '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'. Imugene CMO Dr Paul Woodard added, 'We are very encouraged to received Fast Track Designation by the FDA. We have received a high level of interest from clinicians in the emerging data from the difficult to treat bile duct cancer patient population'.

Summary of FDA fast track designation for Imugene

Imugene Limited (ASX:IMU) has secured FDA Fast Track designation for its MAST clinical program evaluating the safety and efficacy of CF33-hNIS (VAXINIA) in treating bile duct cancer. The Fast Track designation offers increased frequency of meetings with the FDA, eligibility for Accelerated Approval and Priority Review, and regular dialogue known as a Rolling Review in support of a New Drug Application or Biologic License Application. This designation is based on promising Phase 1 efficacy and tolerability data in patients suffering from bile duct cancer, a rare and difficult to treat disease. Imugene will utilize the Fast Track designation to work with the FDA on advancing this important drug program towards patients on an accelerated timeline. The company's vision is to transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments, backed by a growing body of clinical evidence and peer-reviewed research.