Imugene Ltd (ASX:IMU) has received approval from the Institutional Review Board of the Taipei Veterans General Hospital in Taiwan for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.
HER-Vaxx is a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.
Rather than attacking the cancer directly, as chemo does, immunotherapy tries to rally the patient’s own immune system to fight the disease.
The approval in Taiwan follows the University of Hong Kong Institutional Review Board Approval in July.
Hong Kong and Taiwan are two of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.
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.
Gastric cancer represents an area of high unmet medical need, particularly in Asia.
Imugene held $1.6 million in cash as at 30 June 2016.
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