Imugene Ltd (ASX:IMU, OTC:IUGNF) has marked a major breakthrough with its CF33 MAST VAXINIA study, as a patient from the Phase 1 MAST trial has surpassed more than two years in remission, retaining a complete response.
The Bile Tract Cancer Expansion part of the trial has also cleared its first cohort after the first three patients were evaluated for safety and received no dose-limiting toxicities (DLTs).
The expansion portion of the trial is now open for full enrolment of up to 10 patients.
IMU recently received a patent extension to 2040 from the US Patent and Trademark Office for patent application number 16/324,541 which protects its oncolytic virotherapy CF33, including VAXINIA (CF33-hNIS) and CHECKVacc (CF33-hNIS-antiPDL1).
Multiple milestones achieved
“Imugene receiving this patent extension to 2040 from the US patent office is a significant milestone for the CF33 family of oncolytic viruses,” Imugene CEO Leslie Chong said.
“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 enrol into the bile tract cancer expansion of the MAST trial.”
IMU received FDA Fast Track Designation in November last year for its VAXINIA MAST clinical program and its treatment of Bile Tract Cancer, offering an expedited program and approval process with closer cooperation with the regulatory body.
In September, IMU also secured Orphan Drug Designation from the FDA for VAXINIA’s treatment of Bile Tract Cancer, offering seven years of market exclusivity and a range of incentives and fast-track opportunities.