Imugene has treated the first of ten Australian patients with its effective “VAXINIA” therapy in its Phase 1 bile duct cancer trial being conducted at St. Vincent’s Hospital in Melbourne.
The study aims to prove the therapy’s ability to kill the difficult-to-treat, insidious disease that forms in the body’s bile ducts, following positive results in the company’s first phase of testing for metastatic advanced solid tumors (MAST).
Imugene’s CF33-VAXINIA therapy recently produced surprising results in trials for the treatment of bile duct cancer, also known as cholangiocarcinoma. A patient who had failed three previous therapies achieved a complete remission.
After receiving a medium dose of VAXINIA intratumorally (IT), the patient achieved complete remission, meaning all signs of the cancer disappeared after treatment. Encouragingly, a second patient with bile duct cancer also achieved disease stabilization for more than four months after receiving VAXINIA intravenously (IV).
Interim results from the MAST trial so far have shown several positive responses in patients with gastrointestinal cancer. The latest Phase 1 trial is an extension of the previous MAST trials.
Given the results to date, we are excited to explore the potential of VAXINIA in bile duct cancer. We look forward to moving the study to higher doses to collect more important data and make a real difference for patients who need innovative treatment options.
The first multicenter Phase 1 trial of VAXINIA began with a low dose administered to MAST patients who had previously received at least two standard treatments. The trial has since been expanded to include different patient populations, with both intrathoracic and intravenous doses administered.
Since the individual phases were completed without safety-related issues, a higher-dose cohort was recruited and tested with the potent drug, which shrank colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models. The monotherapy part of the study has evolved into a combination study in which the known inhibitor pembrolizumab is administered together with VAXINIA.
The study’s Cohort Review Committee recently approved the fifth cohort for the IT and IV arms, with a sixth cohort of a dose-escalation study beginning to dose the first patient at St. Vincent’s.
In a positive move for the company, the U.S. Food and Drug Administration (FDA) – a federal agency of the Department of Health and Human Services – granted the MAST clinical program a Fast Track Designation for the treatment of bile duct cancer. This allows Imugene to work with the FDA to expedite the program and the approval process.
Imugene’s goal is to develop a range of novel immunotherapies that activate the immune systems of cancer patients to treat and potentially eradicate cancer tumors. The company’s VAXINIA therapy has met some early goals by producing a complete remission in one patient, which will only encourage the company to go even further in its bold quest to eradicate cancer.
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