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Expansion Study for Bile Tract Cancer Commences Following Approval of Imugene’s MAST Trial High Dose Cohort

Tuesday, April 16, 2024

Imugene Limited (ASX: IMU) has initiated enrollment for its expansion study targeting bile tract cancer (cholangiocarcinoma) patients. This comes after completing the fifth cohort in the high dose segment of the intratumoural (IT) arm of the monotherapy dose escalation study, evaluating its cancer-killing virus CF33-hNIS (VAXINIA).

Leslie Chong, Imugene's Managing Director & CEO, expressed excitement about commencing the cholangiocarcinoma expansion study. Chong highlighted the significant impact witnessed in gastrointestinal cancers, notably in cholangiocarcinoma cases, where one patient achieved complete response, and another attained stable disease. The enrollment coincides with the presentation of VAXINIA technology at the 2024 Cholangiocarcinoma Foundation Annual Conference.

The expansion aims to include 10 patients with bile tract cancers following encouraging responses observed in gastrointestinal cancers, particularly cholangiocarcinoma. Cholangiocarcinoma, characterized by malignant cancer cells in the bile ducts, poses challenges in treatment and typically exhibits poor response to immunotherapy drugs.

Notably, a patient with cholangiocarcinoma, who had undergone three prior lines of therapy, achieved complete response after receiving mid-dose IT-administered monotherapy VAXINIA, with no recurrence in over 430 days. Another patient, also with cholangiocarcinoma and having progressed on previous drug therapies, achieved stable disease for over four months post IV-administered VAXINIA.

In November 2023, FDA granted Fast Track Designation to the VAXINIA MAST clinical program for treating bile duct cancer (cholangiocarcinoma), enabling closer collaboration with FDA to expedite the program and potential approval process. This designation followed promising Phase 1 efficacy and tolerability data.

The recent clearance by the Cohort Review Committee of the fifth cohort in the IT arm of the monotherapy dose escalation segment of the MAST trial, without safety signals, is a significant milestone. Enrollment continues for the VAXINIA and pembrolizumab combination segment, with 16 patients dosed thus far.

The Phase 1 MAST trial, conducted across multiple centers, initially administered a low dose of VAXINIA to patients with metastatic or advanced solid tumors who had received at least two prior lines of standard care treatment. With no safety concerns identified so far, the trial progressed through monotherapy dose escalation cohorts and combination studies with pembrolizumab, a well-known checkpoint inhibitor. CF33 oncolytic virus, developed by City of Hope, has demonstrated tumor shrinkage in preclinical laboratory and animal models for colon, lung, breast, ovarian, and pancreatic cancers.



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