Imugene Ltd (ASX:IMU), a clinical stage immuno-oncology company, has initiated a pan-Asia trial of the company’s HER-Vaxx therapy for gastric cancer patients by making a regulatory package submission for the Phase 1b/2 study in Hong Kong.
This filing represents the first submission to various regulators across Asia to initiate clinical testing of Imugene’s HER-Vaxx therapy, given the high unmet need in this area for patients who have HER-2 positive gastric cancer.
HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.
Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.
In conjunction with Novotech, Imugene’s contract research organisation for the study, the company has filed to initiate the study with the Department of Health of Hong Kong.
The proposed HER-Vaxx Phase 1b/2 study 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 is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.
The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.
Imugene has identified eight study sites in Asia to participate in the Phase 1b part of the study. Regulatory filings in other jurisdictions will be done in the next two months.
The principal investigator for Imugene’s Hong Kong site will be Dr Thomas Yau, one of Hong Kong’s leading medical oncologists, whose main research priority is gastrointestinal oncology.
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