Imugene (ASX:IMU), a clinical stage immuno-oncology company, has announced preparations are underway to begin the Phase 2 study of its HER-Vaxx cancer vaccine in gastric cancer patients in early 2019 after completing the Phase 1b study.
A Phase 1b lead-in study tested three doses of HER-Vaxx (IMU-131) in combination with current standard of care chemotherapy (Cisplatin and Fluorouracil or Capecitabine).
The company said medical researchers observed no safety issues and it showed an increase of antibody levels at all dose levels. The study Cohort Review Committee (CRC) selected the recommended Phase 2 dose (RP2D).
According to Imugene managing director and CEO Leslie Chong, “Clinicians at the trial sites observed no vaccine-related toxicities at any of the three doses. We are encouraged by the fact that all vaccinated patients developed increased antibody levels to the HER-2 target protein.
“We look forward to reporting the top-line results before the end of the year and starting the Phase 2 randomised trial early in 2019.
“Completion of the Phase 1b dose escalating trial and start of the Phase 2 study are important milestones for Imugene and the many medical professionals seeking treatments for patients with advanced gastric cancer who often have very few medical options.”
HER-Vaxx is designed to produce an antibody response against a cancer growth signal receptor protein called HER2 and found on the cell surface in breast and gastric cancers.
The company said the sequential dose escalation study in three groups of patients was designed to evaluate the safety, tolerability, immunology and clinical activity of HER-Vaxx in combination with standard of care chemotherapy and establish the optimal dose for a larger Phase 2 study.
The Phase 2 study will test the efficacy, safety and immune response in 68 gastric cancer patients with metastatic gastric cancer overexpressing the HER-2 protein. The Phase 2 study will be randomised 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 will be conducted at sites across Asia, Eastern Europe and India where clinicians and patients have difficulty accessing treatments.