Imugene Ltd (ASX:IMU, OTC:IUGNF) has dosed the first patient in the nextHERIZON Phase 2 clinical trial investigating the biotech’s immunotherapy candidate HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with HER-2+ gastric cancer.
The first patient was dosed at the Queen Elizabeth Hospital in Adelaide, Australia, under the direction of the Principal Investigator, Professor Tim Price.
Additional study sites are expected to open in Australia, as well as the USA under the Food and Drug Administration (FDA) investigational new drug (IND) approval received in December 2021 as the study continues.
Imugene received ethics approval on May 10, 2022, giving it the all-clear to start the trial.
Assessing safety and efficacy
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.
“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,” Imugene’s MD & CEO Leslie Chong said.
“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.”
Full details on the study can be viewed at: https://clinicaltrials.gov/ct2/show/NCT05311176