Imugene Meets Endpoints in Phase 1b Gastric Cancer Immuno-oncology Trial

Imugene Limited, a clinical stage immuno-oncology company recently announced meeting study endpoints and positive top-line results from the Phase 1b study of its HER-Vaxx gastric cancer vaccine in patients expressing the HER2 target protein. The 14 patient study tested three dose levels of HER-Vaxx (10, 30 and 50 micrograms) in combination with current standard of care chemotherapy, cisplatin and fluorouracil or capecitabine. All dose levels showed an increased antibody response in patients.

HER-Vaxx is designed to produce an antibody response against a cancer growth signal receptor protein called HER-2 which is found on the cell surface in breast and gastric cancers. The Phase 2 study will test the efficacy, safety and immune response in 68 gastric cancer patients with metastatic gastric cancer over-expressing the HER-2 protein. The three primary endpoints for the Phase 1 study were safety and tolerability and identification of the optimal dose of the HER-Vaxx cancer vaccine for a Phase 2 study based on data collected over the first eight weeks of treatment.