- Imugene (IMU) receives Human Research Ethics Committee (HREC) approval to start a phase two clinical trial of its cancer vaccine, HER-Vaxx in Australia
- This approval confirms the company has completed pre-clinical safety and efficacy for the phase two trial, dubbed nextHERIZON
- Imugene says the aim of the trial is to assess the safety and efficacy of HER-Vaxx in combination with chemotherapy or pembrolizumab in certain cancer patients
- The company will now notify the Therapeutic Goods Administration (TGA) of its HREC approval before conducting local site initiation activities
- Before market open, shares are trading at 16 cents each
Imugene (IMU) has received Human Research Ethics Committee (HREC) approval to start a phase two clinical trial of its cancer vaccine, HER-Vaxx in Australia.
This approval is confirmation the company has completed pre-clinical safety and efficacy in order to commence its nextHERIZON clinical trial.
This trial will assess the safety and efficacy of HER-Vaxx in combination with chemotherapy or pembrolizumab in certain cancer patients.
According to the company, the main focus is on safety and response rate, but it will also monitor duration of response, survival, and biomarker evaluation.
Imugene will now notify the Therapeutic Goods Administration (TGA) of its HREC approval before conducting local site initiation activities.
Two Australian hospitals have received ethics approval, with additional sites to be opened in Australia and the US.
“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,” Managing Director and CEO Leslie Chong said.
Before the market opens for the day, IMU shares were trading at 16 cents each on May 9.