Imugene Ltd (ASX: IMU) has announced positive updates from its Phase 1 MAST (Metastatic Advanced Solid Tumours) trial, showcasing the potential of its novel cancer-killing virus, CF33-hNIS (VAXINIA). A patient with bile tract cancer in the trial has maintained a complete response for over two years, marking a significant milestone in the study of this oncolytic virus.
Sustained Remission in Bile Tract Cancer
The announcement highlights that a bile tract cancer patient treated with VAXINIA in the Phase 1 MAST trial has remained in complete remission for more than two years. This sustained response is particularly noteworthy given the limited treatment options typically available for this aggressive cancer. The MAST trial is designed to evaluate the safety and efficacy of VAXINIA in patients with advanced solid tumors.
Expansion Cohort Progress
Imugene also reported that the Bile Tract Cancer Expansion part of the MAST trial has successfully cleared its first cohort of patients. The initial three patients were evaluated for safety, and no dose-limiting toxicities (DLTs) were observed. This positive safety profile has allowed the trial to proceed to full enrollment, with plans to include up to 10 patients in this expansion cohort.
Regulatory Milestones and Patent Extension
The company has achieved significant regulatory milestones for VAXINIA, including FDA Fast Track Designation in November 2023 and Orphan Drug Designation in September. These designations are intended to accelerate the development and approval process for VAXINIA in the treatment of bile tract cancer, offering potential benefits such as closer cooperation with the FDA, accelerated approval pathways, and market exclusivity.
Further bolstering its market position, Imugene has been granted a patent extension in the United States, extending protection for its oncolytic virotherapy CF33, including VAXINIA and CHECKVacc (CF33-hNIS-antiPDL1), until 2040. This patent extension from the US Patent and Trademark Office (USPTO) covers patent application number 16/324,541.
Management Commentary
Leslie Chong, CEO of Imugene, commented on these developments, stating, "Imugene receiving this patent extension to 2040 from the US patent office is a significant milestone for the CF33 family of oncolytic viruses. The US is the core healthcare market, and we are delighted to strengthen the patent life."
She added, "We're also 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 enroll into the bile tract cancer expansion of the MAST trial."
