Australian biotechnology firm Imugene has commenced dosing of patients in a Phase II clinical trial of its HER-Vaxx (IMU-131) cancer vaccine to treat HER-2 positive advanced gastric cancer.
HER-Vaxx is being developed to generate an antibody response against the HER-2 cancer growth signal receptor protein present on the cell surface of various tumours such as breast and gastric cancers.
The open-label, randomised, multi-centre Phase II trial will assess the safety, efficacy and immune response of the cancer vaccine in 68 subjects suffering from metastatic gastric cancer overexpressing the HER-2 protein.
During the trial, HER-Vaxx in combination with standard of care chemotherapy will be compared to standard of care alone.
The primary endpoint of the trial is overall survival, while the secondary endpoint will be measured as progression-free survival.
The trial will be carried out at various centres in Asia, Eastern Europe, and India. The first patient has been dosed at the Oncological Institute in Chisinau, Moldova, in eastern Europe.
Currently, two eastern European sites are actively enrolling, and Imugene expects to receive approvals for additional sites in Hong Kong, Taiwan, Thailand and India.
Imugene managing director and CEO Leslie Chong said: “There is strong medical investigator interest following the good results seen in the recently completed Phase Ib trial, where 11 out of 14 evaluable patients showed clinically meaningful responses.
“We look forward to providing regular recruitment updates as the Phase II study moves toward completion in 2020.”
Data from the Phase Ib trial revealed no safety or toxicity issues, with all evaluable patients demonstrating increased antibody responses.
One of the patients experienced a complete response, while five achieved a partial response and four demonstrated disease stabilisation.