Imugene Ltd (ASX:IMU, OTC:IUGNF) is poised to begin the Australian component of a phase 2 clinical trial of cancer immunotherapy candidate HER-Vaxx following approval from the Human Research Ethics Committee (HREC).
The approval has been secured following the completion of all necessary pre-clinical safety and efficacy testing of HER-VAXX required to begin the nextHERIZON clinical trial in Australia.
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.
Primary endpoints include safety and response rate, while secondary endpoints concern duration of response, progression-free survival, overall survival and biomarker evaluation.
“Significant milestone”
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.”
The Australian component of the trial will be conducted under Australia’s Clinical Trials Notification (CTN) Scheme, which involves communication with the Therapeutic Goods Administration on HREC approval and the activities undertaken at local site initiations.
Queen Elizabeth Hospital in Adelaide, South Australia, was the first hospital to receive ethics approval under the direction of principal investigator Dr Tim Price.
Additional clinical sites will be opened in Australia and also in the US under Food and Drug Administration (FDA) investigational new drug (IND) approval in December 2021.