First patient dosed in Phase 1 bile tract cancer trial

On July 10, 2024 Imugene Limited (ASX:IMU), a clinical stage immune-oncology company, reported that the first patient has been dosed in its trial for bile tract cancer (cholangiocarcinoma) patients (Press release, Imugene, JUL 10, 2024, View Source [SID1234644754]).

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This is an expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial after early responses were observed in gastrointestinal cancers, and particularly cholangiocarcinoma, using Imugene’s cancer-killing virus CF33 (VAXINIA).

The first patient in the trial was treated at St. Vincent’s Hospital, with a total of 10 patients to be enrolled.

Imugene Managing Director & CEO Leslie Chong said: "Given the results we’ve seen to date we are eager to see the potential of VAXINIA in bile tract cancer. We look forward to now advancing to the higher doses in the trial to gather further key data and make a genuine difference to patients in need of innovative treatment options."

In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile tract cancer, which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process.

Bile tract cancer 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 bile tract cancer 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, and the patient has been on the study for over 620 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.

The Cohort Review Committee has now cleared the fifth cohort for both arms, intratumoral (IT) and intravenous (IV), of the monotherapy dose escalation portion of the MAST trial, with no safety signals observed thus far. Consequently, the sixth cohort of each arm of the dose escalation trial are now open and enrolling.

*Further dose escalation to continue as long as no safety issues are observed

The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. CF33 oncolytic virus, developed by City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹.