Imugene Ltd (ASX:IMU, OTC:IUGNF) has opened higher on being 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.
Imugene will now have access to more frequent meetings and communications with the FDA, potentially receiving rolling review of its biologic licence application (once submitted) and may be eligible for accelerated approval and priority review, if relevant criteria are met, for VAXINIA in bile duct cancer.
Earlier drug approval potential
Imugene CEO and MD Ms Leslie Chong said: “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.”
Investors have also welcomed the news, sending Imugene shares 26.38% higher to A$0.115 at the ASX opening.
The benefits of Fast Track designation include increased frequency of meetings with the FDA to discuss the drug’s development plan; eligibility for accelerated approval and priority review; and regular dialogue with the FDA in support of a new drug application or biologic licence application.
Imugene CMO Dr Paul Woodard said: “We are very encouraged to have 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.”
The grant of the Fast Track designation was based on the promising data package from Imugene detailing Phase 1 efficacy and tolerability data in patients suffering with bile duct cancer.
Bile duct cancer is a rare disease in which malignant cells form in the bile ducts. These cancers are difficult to treat and typically respond poorly to immunotherapy drugs.
Phase 1 MAST trial ongoing
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment.
The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.
Overall, the study aims to recruit cancer patients across approximately 12 trial sites in the United States and Australia. The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources.