- Imugene (ASX:IMU) reaches a milestone in its MAST clinical program using its novel cancer-killing virus, Vaxinia, receiving fast-track designation from the US FDA
- Fast-track designation enables closer collaboration between Imugene and the FDA and puts IMU at the top of the list for priority review to accelerate future approvals
- The drug is approved to treat bile duct cancer and won approval based on promising data from IMU’s bile duct cancer phase one efficacy and tolerability trial
- Imugene meetings with the FDA will increase to discuss Vaxinia’s development plan as the company gears toward a new drug application or biologic license
- IMU shares are up 20.9 per cent, trading at 11 cents at 11:19 am AEDT
Imugene (ASX:IMU) has reached a milestone in its metastatic advanced solid tumours (MAST) clinical program using its novel cancer-killing virus, Vaxinia, receiving fast-track designation from the US Food and Drug Administration (FDA).
Fast-track designation will enable closer collaboration between Imugene and the FDA, placing Imugene at the top of the list for priority review to accelerate any future approvals.
The drug has been granted approval for use in the treatment of bile duct cancer and was granted based on promising data from Imugene’s bile duct cancer phase one efficacy and tolerability trial.
“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,” IMU CEO and Managing Director Leslie Chong said.
“We have received a high level of interest from clinicians in the emerging data from the difficult-to-treat bile duct cancer patient population”.
Imugene has won the right to increase the frequency of its meetings with the FDA to discuss Vaxinia’s development plan, and with this regular dialogue, the company is gearing toward a new drug application or biologic license application.
Shares were up 20.9 per cent, trading at 11 cents at 11:19 am AEDT.