On September 8, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported the first patient has been dosed in the nextHERIZON Phase 2 clinical trial investigating Imugene’s immunotherapy candidate HER-Vaxx in combination with chemotherapy or pembrolizumab in patients with HER-2+ gastric cancer (Press release, Imugene, SEP 8, 2022, https://mcusercontent.com/e38c43331936a9627acb6427c/files/1874ff62-f56b-4496-ce1e-5e55594df48c/Imugene_doses_first_patient_in_nextHERIZON_Phase_2_trial.pdf [SID1234619269]).
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The first patient was dosed at the Queen Elizabeth Hospital in Adelaide, Australia, under the direction of the Principal Investigator Professor Tim Price. Imugene expects to open additional study sites in Australia, as well as the USA under the Food and Drug Administration (FDA) investigational new drug (IND) approval received in December 2021.
Commencement of the trial comes following ethics approval announced on 10 May 2022. The open-label, multi-center, 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’s M.D. & CEO, Ms 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.
"About Gastric and Gastro-esophageal Cancer
Treatment of gastric or gastro-esophageal cancer remains an unmet need for HER-2 positive patients after they have failed trastuzumab. Immune checkpoint inhibitors have been successfully introduced to metastatic gastric cancer. Combining HER-Vaxx with immune checkpoint inhibitors may improve treatment outcomes for patients with this difficult to treat cancer.
About HER-Vaxx
Imugene’s HER-Vaxx is a B-cell activating cancer immunotherapy designed to treat tumours that overexpress the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.