Imugene MAST trial delivers two-year complete response in bile tract cancer patient

Imugene Ltd (ASX:IMU) managing director and CEO Leslie Chong joins Proactive’s Tylah Tully to discuss the company’s latest update. A bile tract cancer patient in its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial has maintained a complete response (CR) for over two years.

The MAST study is assessing the safety and efficacy of Imugene’s oncolytic virotherapy, CF33-hNIS (VAXINIA), designed to target and destroy cancer cells.

The bile tract cancer expansion of the trial recently also cleared its first patient cohort, with no dose-limiting toxicities observed, and enrolment is now open for up to 10 additional patients.

VAXINIA has received both FDA Fast Track Designation (November 2023) and Orphan Drug Designation (September 2024) for treating bile tract cancer, supporting faster regulatory pathways and potential incentives such as market exclusivity upon approval.

Additionally, Imugene's intellectual property around CF33 received a US patent extension to 2040, covering both VAXINIA and CHECKVacc variants, reinforcing its presence in the US oncology market.
Chong highlighted the patient’s prolonged response and the importance of the recent patent extension in strengthening Imugene’s position in the core healthcare market.

The company continues to recruit patients for the bile tract cancer segment of the trial.

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