- Imugene (IMU) releases pre-feasibility study data for its HER-Vaxx Phase 2 cancer trial
- The clinical trial was designed to evaluate the safety and immune response in metastatic gastric cancer over-expressing the HER-2 protein
- 36 patients were enrolled, with the study demonstrating the HER-Vaxx does not add toxicity to SOC chemotherapy
- Imugene says it’s still waiting for final evaluations, but has plans for two further Phase 2 studies and one investigator-sponsored study with HER-Vaxx in early and late-stage gastric cancer
- Imugene shares are trading 6.02 per cent down at 39 cents at 10:28 am AEST
Imugene (IMU) has released pre-feasibility study data for its HER-Vaxx immunotherapy trial in HER-2 positive gastric cancer.
The HER-Vaxx is an immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, lung, breast, ovarian and pancreatic cancers.
The Phase 2 HER-Vaxx clinical trial was designed to evaluate the safety and immune response in metastatic gastric cancer overexpressing the HER-2 protein. The study was randomised into one of two arms – either HER-Vaxx plus standard-of-care chemotherapy, or SOC chemotherapy alone, with survival the primary goal.
Thirty-six patients were enrolled, with 24 having achieved progression-free survival in a signal generating study.
There was no difference recorded in safety between the two treatment arms, showing HER-Vaxx did not add toxicity to SOC chemotherapy, with a further detailed safety analysis to be conducted once the trial is complete.
Imugene says it’s still waiting for overall survival evaluation and will subsequently analyse all data.
Based on these results, Imugene says it now has plans for two further Phase 2 studies and one investigator-sponsored study with HER-Vaxx in early and late-stage gastric cancer.
Imugene’s MD and CEO, Leslie Chong said: “We are encouraged by the pre-feasibility study and anticipated primary overall survival clinical data to commence three new HER-Vaxx trials, to be called NextHERIZON, NeoHERIZON and NeuHERIZON, in early and late-stage gastric cancer including combination with PD-1 and PD-L1 checkpoint inhibitors.”
Imugene shares were trading 6.02 per cent down at 39 cents at 10:28 am AEST.