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Clinical stage immuno-oncology company Imugene Limited (ASX: IMU) has opened enrolment for its expansion study in bile tract cancer (cholangiocarcinoma) patients.

The follows the company completing the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA).

“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,” Managing Director and CEO Leslie Chong said.

“It’s timely for enrolment to open as we present our VAXINIA technology to the 2024 Cholangiocarcinoma Foundation Annual Conference later this week.”

The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma.

Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs.

One patient with cholangiocarcinoma who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, with no known recurrence in more than 430 days.

A second patient with cholangiocarcinoma, who has also progressed on prior drug therapies, achieved stable disease for more than four months upon receiving IV-administered VAXINIA.

In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process. This designation followed the promising data detailing Phase 1 efficacy and tolerability.

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