Imugene (ASX: IMU) has dosed its first of 10 Australian patients with its potent “VAXINIA” therapy as part of its phase-one bile tract cancer trial being conducted at St Vincent’s Hospital in Melbourne.
The trial is aimed at proving the therapy’s ability to kill off the difficult-to-treat insidious disease that forms in the body’s bile ducts, following positive phase-one results in the company’s metastatic advanced solid tumours (MAST) testing.
Imugene’s CF33 VAXINIA therapy has recently produced startling results in trials testing its treatment for bile tract cancer, which is also known as cholangiocarcinoma. It included a complete response in one patient, who had failed in three prior lines of therapy.
Upon receiving a mid-dose of intratumoral (IT)-administered VAXINIA, the patient achieved the complete response, meaning all signs of the cancer had disappeared after the treatment was delivered. Encouragingly, a second patient with bile tract cancer also achieved a stablising of the disease for more than four months after VAXINIA had been administered intravenously (IV).
The previous interim results from the MAST trial demonstrated several positive responses in gastrointestinal cancer patients. The latest phase-one trial is an expansion of the previous MAST testing.
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.
Imugene Managing Director and CEO Leslie Chong
The initial phase-one multi-centre VAXINIA trial began with a low-dose delivered to MAST patients who had been through at least two prior lines of standard of care treatment. It has now progressed through various cohort groups of patients, with both IT and IV doses administered.
As the stages progressed with no red-flag safety issues arising, a higher-dose cohort was recruited and tested with the potent drug that has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in pre-clinical laboratory and animal models. The monotherapy arm of the trial has developed into a combination study, where the well-known inhibitor drug pembrolizumab is administered along with VAXINIA.
The trial’s Cohort Review Committee recently cleared the fifth cohort for the IT and IV arms, with a sixth cohort of a dose-escalation trial beginning with the first patient dosed at St Vincent’s.
In a positive move for the company, the United States Food and Drug Administration (FDA) – a Federal agency of that country’s Department of Health and Human Services – granted the MAST clinical program a “Fast Track Designation” for the treatment of bile tract cancer. It allows Imugene to co-operate with the FDA to expedite the program and the approvals process.
Imugene’s goal is to develop a range of novel immunotherapies that assist with activating the immune system of cancer patients to treat and potentially eradicate cancerous tumours. The company’s VAXINIA therapy has kicked some early goals through the complete response in one patient and that will only encourage it to go harder in its bold bid to wipe out cancer.
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