Imugene achieves phase-II clinical trial milestone for HER-Vaxx cancer immunotherapy

Imugene Ltd (ASX:IMU) (OTCMKTS:IUGNF) has achieved a clinical milestone for its HER-Vaxx cancer immunotherapy in Phase 2 gastric cancer clinical trial. Following completion of recruitment in January 2021, the important clinical endpoint of Progression Free Survival (PFS) has been met after the statistically significant required number of PFS events has occurred. Data from these 24 events will now be analysed with the final PFS readout expected within months. "Delighted" Managing director and CEO Leslie Chong said: “I am delighted to report that we have achieved this new significant milestone for patients with advanced gastric cancer, following on from the important interim data released in 2020 and new data presented at AACR earlier this month.” Imugene’s HER-Vaxx is a B-cell activating 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 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 wellknown and validated cancer target. Conducted across Eastern Europe  Phase-2 of the HER-Vaxx study is designed to measure the efficacy, safety and immune response in 36 patients with metastatic gastric cancer overexpressing the HER-2 protein. It is randomised into two arms of either HER-Vaxx plus standard-of-care chemotherapy or standard-ofcare chemotherapy alone. The primary endpoint is overall survival and secondary endpoint is progression-free survival. Safety, tolerability and immune response are also being measured. The  phase-2 trial is being conducted at multiple sites across Eastern Europe and India where clinicians have difficulty accessing approved antibody treatments such as Herceptin® and Perjeta® marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in the countries selected.