Immuno-oncology company Imugene (ASX:IMU) has announced it has received Human Research Ethics Committee (HREC) approval to commence a Phase 2 clinical trial of its immunotherapy candidate, HER-Vaxx in Australia.
Imugene said nextHERIZON is an open-label, multi-centre, signal generating, Phase 2 clinical trial designed to assess the safety and efficacy of HER-vaxx in combination with chemotherapy or pembrolizumab in patients with metastatic HER-2/neu over-expressing gastric or gastroesophageal junction adenocarcinomas who have previously progressed on trastuzumab.
The study’s primary endpoints are safety and response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and biomarker evaluation.
The Australian component of the Phase 2 trial will be conducted under Australia’s Clinical Trials Notification (CTN) Scheme meaning Imugene will notify the TGA of HREC approval and complete local site initiation activities.
The first hospital to receive ethics approval is the Queen Elizabeth Hospital in Adelaide under the direction of Principal Investigator Dr Tim Price.
The company said additional clinical sites will be opened in Australia and also in the US.
Imugene managing director and CEO Leslie Chong said, “The start of our Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of HER-2+ gastric cancer and we look forward to further evaluating HER-Vaxx in combination with pembrolizumab in a relapsed/refractory metastatic setting.”