Imugene Ltd (ASX:IMU, OTC:IUGNF) has dosed the first patient in its trial for bile tract cancer (cholangiocarcinoma) patients.
Trial expansion
The MAST (metastatic advanced solid tumours) Phase 1 trial has been expanded since early responses were observed in gastrointestinal cancers – particularly cholangiocarcinoma – using Imugene’s cancer-killing virus CF33, known as VAXINIA.
The first patient in the trial was treated at St Vincent’s Hospital, Melbourne, Australia, with a total of 10 patients expected to be enrolled.
Interim results from the Phase 1 MAST trial demonstrated positive responses in gastrointestinal cancers, including a complete response (CR) in bile tract cancer.
The fifth cohort of both arms of the Phase 1 MAST monotherapy dose escalation trial has now cleared, with the sixth high-dose cohort of each arm now open.
Potential for bile duct cancer
Imugene managing director and 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 US Food and Drug Administration (FDA) granted fast-track designation to Imugene's VAXINIA MAST clinical program for the treatment of bile tract cancer.
This designation allows for closer cooperation with the FDA to expedite the program and potential approval process.
Rare and challenging disease
Bile tract cancer is a rare and challenging disease where malignant cells form in the bile ducts, often responding poorly to immunotherapy.
In a recent study, one patient who had failed three prior lines of therapy achieved a complete response after receiving a mid-dose of IT-administered VAXINIA monotherapy. This patient has remained in the study for more than 620 days.
Another patient with cholangiocarcinoma achieved stable disease for more than four months after receiving IV-administered VAXINIA.
The Cohort Review Committee has cleared the fifth cohort for both intratumoral (IT) and intravenous (IV) arms of the monotherapy dose escalation portion of the MAST trial, with no safety signals observed.
Consequently, the sixth cohort of each arm is now open for enrolment.
The Phase 1 MAST trial began by administering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who had at least two prior lines of standard treatment.
With no safety issues identified, the trial has progressed through monotherapy dose escalation cohorts and now includes a combination study with the checkpoint inhibitor pembrolizumab.
The CF33 oncolytic virus, developed by City of Hope, has shown effectiveness in shrinking colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical studies.