Imugene Limited announced completion of recruitment to the Phase 2 trial of its B-cell activating immunotherapy HER-Vaxx in Her-2/Neu overexpressing advanced/metastatic gastric/GEJ cancer. Completion of recruitment follows the recent Independent Data Monitoring Committee (IDMC) review of HER-Vaxx Phase 2 interim analysis safety and efficacy data where the IDMC reported no safety concerns and viewed this preliminary data as strongly in favour of a HER-Vaxx survival effect. The IDMC provided guidance that it is scientifically and ethically appropriate to reduce the overall number of patients required to complete the study given the strong signal observed in the data. Following the guidance from the IDMC, Imugene reduced the overall number of patients required to complete the study to 36 patients, all of which have now completed their baseline visit. HER-Vaxx is designed to produce an antibody response against a cancer growth signal receptor protein called HER-2 found on the cell surface in breast and gastric cancers. The Phase 2 study will test the efficacy, safety and immune response in gastric cancer patients with metastatic gastric cancer overexpressing the HER-2 protein. The Phase 2 study randomised patients into two arms of either HER-Vaxx plus standard-of-care (chemotherapy) or standard-of-care alone. The primary endpoint is overall survival and secondary endpoint will be progression-free survival. The Phase 2 trial is being conducted at sites across Asia, Eastern Europe and India where clinicians and patients have difficulty accessing treatments such as Herceptin and Perjeta marketed by Swiss multinational Roche Holding AG. There is also a high prevalence of gastric cancer in many of the countries selected.