Clinical stage immuno-oncology company Imugene Limited (ASX:IMU) provided a clinical trial update of its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial evaluating the safety and efficacy of novel cancer-killing virus CF33-hNIS (VAXINIA).

• Patient hits major milestone in CF33 MAST VAXINIA study, with ‘complete response’ for over two years
• The Cohort review committee has cleared the first cohort of three patients in Bile Tract Cancer Expansion of the VAXINIA trial, with patients continuing to be enrolled
• VAXINIA has received both US Food and Drug Administration Fast Track Designation and Orphan Designation Status

Imugene indicated that a bile tract cancer patient in its Phase 1 MAST trial remains a ‘complete response’, now surpassing more than two years in remission.

The Company also announced that the Bile Tract Cancer Expansion part of this trial had now cleared its first cohort, after the first three patients were evaluated for safety and experienced no dose limiting toxicities (DLTs). As a result, it is now open for full enrolment of up to 10 patients.

Back in November 2023, Imugene received US Food and Drug Administration (FDA) Fast Track Designation for the VAXINIA MAST clinical program and its treatment of Bile Tract Cancer, allowing for closer cooperation with the FDA to expedite the program and the subsequent approval process, including potential for accelerated approval and priority review. The Company subsequently (in September 2024) received Orphan Drug Designation from the FDA for VAXINIA’s treatment of Bile Tract Cancer, providing a range of incentives in addition to seven years market exclusivity upon FDA approval.

Imugene’s CEO, Leslie Chong, said: “We’re very pleased to see the two-year milestone reached for the Bile Tract Cancer patient who has maintained a ‘complete response’ in our MAST study. Most importantly this is an outstanding result for the patient given the limited treatment options available, but also demonstrates the excellent potential of the CF33 oncolytic virus for this and other cancer types. We continue to enrol into the bile tract cancer expansion of the MAST trial.”