Imugene (ASX:IMU)a clinical-stage immuno-oncology company, reported a significant result in its Phase 1 MAST (Metastatic Advanced Solid Tumours) study. The company announced that a patient with biliary tract cancer has maintained a complete response (remission) for over two years. This highlights the potential of Imugene’s therapy, VAXINIA, which uses an engineered virus known as CF33-hNIS to target and kill cancer cells.
Additionally, Imugene has made great strides in expanding testing. The Cohort Review Committee cleared the first three-patient cohort in the biliary tract cancer expansion of the VAXINIA study, indicating safety without dose-limiting toxicities. Imugene is now enrolling additional patients, with the expansion targeting up to ten individuals.
The U.S. Food and Drug Administration (FDA) has granted VAXINIA both Fast Track and Orphan Drug Designations for the treatment of biliary tract cancer. These statuses allow for closer collaboration with the FDA and speed up the drug approval process. Additionally, orphan drug designation grants exclusive market rights in the United States for seven years following approval, which could accelerate the availability of VAXINIA to patients in need.
To strengthen its intellectual property, Imugene recently obtained a patent extension for VAXINIA and another therapy, CHECKVacc (CF33-hNIS-antiPDL1), through 2040 in the United States. This extension increases the commercial potential of Imugene’s oncolytic virotherapy technology in the world’s largest healthcare market.
Leslie Chong, CEO of Imugene, commented: “We are very pleased to see the two-year milestone reached for the biliary tract cancer patient who maintained a complete response in our MAST study. This is an exceptional patient outcome, given the limited treatment options available, and demonstrates the excellent potential of the oncolytic CF33 virus for this and other cancers.”