HER-Vaxx is a potentially ground-breaking cancer vaccine designed to produce an antibody response against a cancer growth signal receptor protein called HER-2.
HER-2 is found on the cell surface of multiple cancers including breast and gastric cancers.
Imugene’s managing director and CEO Leslie Chong said: “There is strong medical investigator interest following the good results seen in the recently completed Phase 1b trial, where 11 out of 14 evaluable patients showed clinically meaningful responses.
“We look forward to providing regular recruitment updates as the Phase 2 study moves toward completion in 2020.”
“The start of the Phase 2 study is an important milestone for Imugene and the many medical professionals seeking treatments for patients with advanced HER-2 positive gastric cancer who often have very few medical options.”
Study being conducted in Asia, Europe and India
The Phase 2 HER-Vaxx study is designed to measure the efficacy, safety and immune response in 68 patients with metastatic gastric cancer overexpressing the HER-2 protein.
The study is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-of-care alone.
The primary endpoint is overall survival and secondary endpoint will be progression-free survival. Safety, tolerability and immune response will also be measured.
The Phase 2 trial is being conducted at multiple sites across Asia, Eastern Europe and India.
Patients in these areas have difficulty accessing approved antibody treatments such as Herceptinâ and Perjetaâ marketed by Swiss multinational Roche Holding AG.
There is also a high prevalence of gastric cancer in the countries selected.