Imugene Ltd (ASX:IMU, OTC:IUGNF) has launched an expansion study targeting patients with bile tract cancer, also known as cholangiocarcinoma, following encouraging results from its MAST (Metastatic Advanced Solid Tumours) trial.
Positive outcomes
Recent interim results from the MAST trial revealed positive outcomes in treating gastrointestinal cancers, particularly cholangiocarcinoma.
Cholangiocarcinoma is a rare and aggressive cancer originating in the bile ducts, which typically shows poor response to conventional immunotherapy. Early trial results have sparked hope, with significant responses observed in patients who have exhausted other treatment options.
The ongoing trial expansion reinforces Imugene’s commitment to developing innovative therapies for such hard-to-treat cancers, with the study is set to enrol 10 patients suffering from cholangiocarcinoma.
The company welcomed the news that one patient undergoing treatment with CF33-hNIS, known commercially as VAXINIA, achieved a complete response, while another exhibited stable disease.
This comes after the fifth cohort of the intratumoural (IT) arm of the VAXINIA monotherapy trial reported no safety concerns, covering various cancers including thymic carcinoma, triple-negative breast cancer and cholangiocarcinoma.
Fast-track FDA designation for MAST
The FDA granted Fast Track Designation to the VAXINIA MAST clinical program in November 2023 for cholangiocarcinoma treatment, which facilitates closer collaboration with the FDA to speed up the review and potential approval process.
A MAST trial, which commenced with a low dose of VAXINIA in patients who had previously undergone at least two standard-of-care treatments, has progressively advanced through dose escalation in both its monotherapy and combination studies.
The combination trial includes the administration of VAXINIA alongside pembrolizumab, a well-known checkpoint inhibitor. To date, 16 patients have been dosed in the combination study.
Imugene managing director and CEO Leslie Chong said: “As a team, we’re particularly eager to begin the cholangiocarcinoma expansion study, given the meaningful difference we’ve seen VAXINIA make for patients with gastrointestinal cancers, including one patient with cholangiocarcinoma who achieved a complete response and another who achieved stable disease.
“It’s timely for enrolment to open as we present our VAXINIA technology to the 2024 Cholangiocarcinoma Foundation Annual Conference later this week.”