- Imugene (IMU) has announced the Independent Data Monitoring Committee (IMDC) has confirmed the safety of the HER-Vaxx immunotherapy study
- This means Imugene can continue its HER-Vaxx phase two trial
- The study is measuring the efficacy, safety and immune response of Imugene’s HER-Vaxx treatment in 68 patients with metastatic gastric cancer who are over-expressing the HER-2 protein
- The trial is being conducted at multiple sites across Eastern Europe and India, which reportedly have a high prevalence of gastric cancer
- Imugene is trading flat at 2.6 cents each
Imugene (IMU) has announced the Independent Data Monitoring Committee (IMDC) has confirmed the safety of the HER-Vaxx immunotherapy study.
The IDMC’s role is to review study data and conduct a formal review of key data from studies, such as the number of deaths, adverse reactions and lab results. This allows the IMDC to weigh up benefits and risks and decide whether a study can and should continue.
As the IDMC members had no safety concerns, the HER-Vaxx phase two study can continue without any modifications.
“I am happy to report that we have achieved this significant milestone and I’m highly encouraged by the positive outcome of this first IDMC meeting. I am truly pleased with the study progress to date,” Imugene Managing Director and CEO Leslie Chong said.
HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
The study is measuring the efficacy, safety and immune response of Imugene’s HER-Vaxx treatment in 68 patients with metastatic gastric cancer who are over-expressing the HER-2 protein.
The study is randomised into two arms, with patients receiving either HER-Vaxx as well as standard-of-care chemotherapy or standard-of-care chemotherapy alone.
The phase two trial is being conducted at multiple sites across Eastern Europe and India, where clinicians have difficulty accessing certain approved antibody treatments. Reportedly, these areas also have a high prevalence of gastric cancer.
Imugene is trading flat at 2.6 cents each at 10:03 am AEST.