Clinical stage immuno-oncology company Imugene (ASX:IMU) has announced that the first patient has been dosed in the nextHERIZON Phase 2 clinical trial.
The trial is investigating Imugene's immunotherapy candidate HER-Vaxx in combination with chemotherapy or MSD's KEYTRUDA (pembrolizumab) in patients with HER-2+ gastric cancer.
The first patient was dosed at the Queen Elizabeth Hospital in Adelaide under the direction of the principal investigator Professor Tim Price.
Imugene said it expects to open additional study sites in Australia and the US under the FDA investigational new drug approval received in December 2021. Commencement of the trial comes following ethics approval announced on 10 May 2022.
The open-label, multi-centre, signal-generating, Phase 2 clinical trial is designed to assess the safety and efficacy of HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with metastatic HER-2/neu overexpressing gastric or gastroesophageal junction adenocarcinomas, who have previously progressed on trastuzumab.
The study’s primary endpoints are safety and response rate, while secondary endpoints include duration of response, progression-free survival, overall survival, and biomarker evaluation.
Imugene managing director and CEO Leslie Chong said, “Evidence to date has shown the potential to overcome resistance to immunotherapy within GI cancers by increasing cytotoxic and effector immune cells within the tumour microenvironment. Immunotherapies such as HER-Vaxx, particularly in combination with immune checkpoint inhibitors such as pembrolizumab, may hold the solution. With the promising results we've seen from HER-Vaxx thus far, we're particularly eager to take the next step in its development with this trial and ideally improve outcomes for patients with this difficult-to-treat cancer.”