Imugene (ASX:IMU) has announced 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 trial is evaluating the safety and efficacy of the novel cancer-killing virus CF33-hNIS (VAXINIA).
The company confirmed that the trial's Bile Tract Cancer Expansion part cleared its first cohort after the first three patients were evaluated for safety and experienced no dose-limiting toxicities (DLTs). It is now open for full enrolment of up to 10 patients.
Imugene received FDA Fast Track Designation in November 2023 for the VAXINIA MAST clinical program and its treatment of Bile Tract Cancer. This designation allows for closer cooperation with the FDA to expedite the program and the subsequent approval process, including potential for accelerated approval and priority review.
In September 2024, the company received an Orphan Drug Designation from the FDA for VAXINIA’s treatment of Bile Tract Cancer.
Imugene also recently received a patent extension to 2040 from the US Patent and Trademark Office. The patent protects its oncolytic virotherapy CF33, including VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1).
Imugene CEO Leslie Chong said, “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.
“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.”