Imugene receives board approval for study

Company News

Imugene (ASX:IMU), a clinical stage immuno-oncology company, has announced it has received approval from the Institutional Review Board from the University of Hong Kong for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

The company said the approval positions it to enrol patients in the Phase 1b/2 in HER2 positive gastric cancer study within the coming months.

"Completing this major milestone underscores HER-Vaxx re-entry into the clinic with the Phase 1b/2 in HER2 positive gastric cancer study, which represents an area of high unmet medical need, particularly in Asia," said the company.

The proposed HER-Vaxx Phase 1b/2 will be conducted in two parts. The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels. This first stage will provide safety data, immunogenicity data (a measure of how many of the HER2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study or recommended Phase 2 dose (RP2D).

The larger open label Phase 2 study will recruit around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

“This significant milestone and achievement puts us on track to provide much needed therapy to our patients and to obtain valuable data for Imugene. I am thankful for my clinical development team on their achievement and dedication for the successful re-entry of Her-Vaxx into the clinic in 2016," said Imugene’s Chief Operating Officer, Leslie Chong.