Imugene Limited (ASX:IMU, OTC:IUGNF), a clinical-stage immune-oncology company, has revealed secondary efficacy endpoint progression-free survival (PFS) data for its HER-Vaxx immunotherapy in HER-2 positive gastric cancer.
The Phase 2 HER-Vaxx clinical trial is designed to evaluate the efficacy, safety and immune response in metastatic gastric cancer overexpressing the HER-2 protein.
Based on these results, Imugene now plans two further company-sponsored phase 2 studies and one investigator-sponsored study with HER-Vaxx in early and late-stage gastric cancer.
“Encouraged by PFS”
Imugene MD and CEO Leslie Chong said: “We are encouraged by the PFS and anticipated primary OS 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.
“These studies will be conducted in the US, Australia and South Korea.”
The study is randomised into two arms of either HER-Vaxx plus standard-of-care (SOC) chemotherapy or SOC chemotherapy alone.
Primary endpoint is overall survival (OS) and the secondary endpoint includes PFS by independent central review.
To date, 36 patients have been enrolled and 24 have achieved a PFS event in this signal generating study.
Imugene is awaiting the events needed for OS evaluation and will subsequently analyse all data including final OS, PFS, safety, and immune responses.
Imugene’s HER-Vaxx is a B-cell activating immunotherapy designed to treat tumours that overexpress the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu.
It has been shown in pre-clinical studies, in phase I and now phase 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.
The HERIZON Phase 2 trial, which has completed recruitment, is being conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptin®.
- Ephrems Joseph