Imugene (ASX:IMU), a clinical-stage immuno-oncology company, has reported a significant achievement in its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial. The company announced that a patient with bile tract cancer has now maintained a complete response (remission) for over two years. This highlights the potential of Imugene’s therapy, VAXINIA, which utilises an engineered virus known as CF33-hNIS to target and kill cancer cells.
In addition, Imugene has made strides in expanding its trial. The Cohort Review Committee has cleared the first cohort of three patients in the VAXINIA trial’s bile tract cancer expansion, indicating safety with no dose-limiting toxicities. Imugene is now enrolling additional patients, with the expansion targeting up to ten individuals.
The US Food and Drug Administration (FDA) has granted VAXINIA both Fast Track and Orphan Drug Designations for bile tract cancer treatment. These statuses allow for closer FDA collaboration and expedite the drug approval process. Additionally, the Orphan Drug Designation provides exclusive market rights in the US for seven years upon approval, which could accelerate VAXINIA’s availability for patients in need.
To strengthen its intellectual property, Imugene recently secured a patent extension for VAXINIA and another therapy, CHECKVacc (CF33-hNIS-antiPDL1), through 2040 in the US. This extension enhances the commercial potential of Imugene’s oncolytic virotherapy technology in the world’s largest healthcare market.
Leslie Chong, Imugene’s CEO, commented, “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. This is an outstanding result for the patient, given the limited treatment options available, and it demonstrates the excellent potential of the CF33 oncolytic virus for this and other cancer types.”
