Imugene Limited (ASX: IMU) has commenced a trial for bile tract cancer patients with their cancer-killing virus CF33 (VAXINIA) after promising early responses in gastrointestinal cancers, particularly cholangiocarcinoma. The first patient was dosed at St. Vincent’s Hospital, with 10 patients planned for enrolment. Imugene's CEO, Leslie Chong, expressed optimism about the trial's potential impact and the FDA's Fast Track Designation granted in November 2023 for VAXINIA in bile tract cancer treatment, facilitating a closer cooperation with FDA for faster progress and potential approval.
Bile tract cancer, known for its resistance to immunotherapy drugs, showed promising results in a trial using VAXINIA. A patient achieved a complete response after receiving IT-administered VAXINIA, while another with cholangiocarcinoma had stable disease with IV-administered VAXINIA. The trial's Cohort Review Committee approved the fifth cohort for both administration methods, with no safety concerns, leading to the opening of the sixth cohort for enrolment.
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