Imugene granted fast-track status for development of Vaxinia to treat bile duct cancers
Clinical-stage immuno-oncology company Imugene (ASX: IMU) has received fast-track designation from the US Food and Drug Administration (FDA) for a clinical program to evaluate the effect of novel cancer-killing virus CF33-hNIS (Vaxinia) on bile duct tumours.
The designation was based on “promising data” from a Phase 1 trial into the efficacy and tolerability of the novel oncolytic virus on patients with bile duct cancer (also called cholangiocarcinoma).
The 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.
It started in May 2022 and is expected to run for 24 months while being funded from existing budgets and resources.
Imugene aims to recruit cancer patients across 12 trial sites in the US and Australia.
Bile duct cancers are difficult to treat and typically respond poorly to immunotherapy drugs.
Vaxinia has been previously shown to shrink colon, lung, breast, ovarian and pancreatic tumours in pre-clinical laboratory and animal models.
Fast-track designation is awarded to accelerate the development and marketing of new therapies for serious conditions and will offer Imugene a closer co-operation with the FDA to expedite the metastatic advanced solid tumours program and subsequent approval processes.
It will also allow for increased frequency of meetings to discuss the drug’s development plan and “rolling reviews” in support of a new drug or biologic license application, as well as eligibility for accelerated approval and priority review.
High level of interest
Managing director Leslie Chong said the designation was received alongside a high level of interest from clinicians involved with the difficult-to-treat bile duct cancer patient population.
“The fast-track process of drug development is designed to facilitate the development and review of drugs to treat serious conditions and fill an unmet medical need,” she said.
“Fast-track status often leads to earlier drug approval and ultimately, access by patients.”