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Imugene launches pivotal bile tract cancer expansion study


Imugene’s MAST trial is showing positive results on patients suffering from gastrointestinal cancers. Credit: File

ASX-listed medical technology company Imugene (ASX: IMU) has launched a pivotal expansion study targeting patients with bile tract cancer, also known as cholangiocarcinoma, following encouraging early results from its Metastatic Advanced Solid Tumours (MAST) trial.


Cholangiocarcinoma is a rare and aggressive cancer that originates in the bile ducts and typically shows a poor response to established immunotherapy drugs. Early trial results have sparked hope, with significant positive responses observed in patients who have exhausted other treatment options.


The trial expansion emphasises Imugene’s commitment to developing innovative therapies for hard-to-treat cancers. The expansion study is set to enrol 10 patients suffering from cholangiocarcinoma.


Notably, interim results from the recent MAST trial revealed optimistic outcomes in treating gastrointestinal cancers, particularly cholangiocarcinoma. Significantly, one patient undergoing treatment with the drug “CF33-hNIS”, known commercially as VAXINIA, achieved a complete recovery despite having had no luck with three prior therapies, while another exhibited stable disease, meaning the tumour stopped growing.


It comes after the fifth cohort of the intratumoural (IT) arm of the VAXINIA monotherapy trial reported no safety concerns.


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.
Imugene managing director and chief executive officer Leslie Chong

In November last year, the US Food and Drug Administration (FDA) granted Fast Track Designation to the VAXINIA MAST clinical program for cholangiocarcinoma treatment. It effectively means a closer collaboration with the FDA to help speed up the review and potential approval process.


Imugene’s MAST trial, which began with a low dose of VAXINIA in patients who had previously undergone at least two standard-of-care treatments, has progressively advanced the amount of drug given in both its monotherapy and combination studies.


The combination trial includes the administration of VAXINIA alongside pembrolizumab, a well-known checkpoint inhibitor. Checkpoint inhibitors are a type of immunotherapy that block proteins which stop the immune system from attacking the cancer cells.


To date, 16 patients have been dosed in the combination study.


Imugene is this week scheduled to present VAXINIA at the 2024 Cholangiocarcinoma Foundation Annual Conference at Salt Lake City in the United States. The company continues to gather favour for its cutting-edge therapies that have so far shown no safety concerns across various cancer types, including thymic carcinoma and triple-negative breast cancer.


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