- Imugene Limited (ASX:IMU) has secured ethics approval to begin a Phase 2 clinical trial of HER-Vaxx in Australia.
- The clinical study is being conducted in patients with metastatic HER-2 positive gastric cancer.
- Safety and response rates are the primary endpoints of the Phase 2 clinical trial of HER-Vaxx.
Clinical stage immuno-oncology player Imugene Limited (ASX:IMU) has now received Human Research Ethics Committee (HREC) approval to start a Phase 2 clinical trial of HER-Vaxx in Australia. The approval represents a significant milestone for the Company and is welcome news for Aussies suffering from HER-2+ gastric cancer.
Imugene’s HER-Vaxx is a B-cell peptide immunotherapy cancer vaccine candidate designed to treat tumours that over-express the HER-2/neu receptor, like gastric, lung, ovarian, breast and pancreatic cancers. In the prior studies, HER-Vaxx has already shown a tolerable safety profile as well as encouraging efficacy in patients diagnosed with metastatic HER-2 positive gastric cancer.
Details of ethics approval
As per Imugene, ethics approval is a confirmation that it has completed all the necessary pre-clinical safety and efficacy testing of B-cell immunotherapy HER-Vaxx required to start its nextHERIZON clinical study in Australia.
The Australian component of the Phase 2 trial will be undertaken under Australia’s Clinical Trials Notification (CTN) Scheme. It means the Company will notify the TGA (Therapeutic Goods Administration) of HREC approval and finalise local site initiation activities.
The first hospital to receive ethics approval in Australia is the Queen Elizabeth Hospital, Adelaide, under the direction of Principal Investigator Dr Tim Price. The Company informed that additional clinical sites will be opened in Australia as well as the United States under FDA (Food and Drug Administration) investigational new drug approval in December 2021.
About nextHERIZON clinical trial
nextHERIZON is an open-label, signal generating, multi-center, Phase 2 clinical study designed to evaluate the efficacy and safety of HER-Vaxx in combination with chemotherapy or pembrolizumab in patients suffering from metastatic HER-2/neu over-expressing gastric or gastroesophageal junction adenocarcinomas who had prior exposure to trastuzumab.
The primary endpoints of the study are safety and response rate. However, the secondary endpoints include progression free survival, duration of response, overall survival, and biomarker evaluation.
Imugene shares are trading at A$0.165 as of 11:20 AM AEST, with a rise of over 3.1%.