New trial for Imugene's HER-Vaxx immunotherapy

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Immuno-oncology company Imugene (ASX:IMU) has announced it has commenced first patient dosing of the Phase 1b/2 clinical study of its HER-Vaxx immunotherapy in gastric cancer. 

Patients are currently being enrolled at eight key cancer hospital sites across Asia. 

The study is being conducted at eight key cancer hospital sites across Asia where there are high rates of gastric cancer and where patients have difficulty accessing expensive antibody treatments.

According to Imugene CEO, Leslie Chong, “The successful start of this study represents an important development milestone for our business and medical professionals seeking new ways to treat patients with gastric cancer.”

HER-Vaxx is designed to produce a strong antibody response against a growth signal receptor protein called HER2 which is found on the cell surface in gastric cancers.

The company says it believes, based on recently published preclinical data, HER-Vaxx will stimulate a rapid and strong immune response against cancerous cells.

The announced trial is testing three different doses of the HER-Vaxx vaccine with up to 18 patients - three groups up to six patients - in combination with chemotherapy.

The key endpoints are to identify the optimal dose of HER-Vaxx for the Phase 2 part of the study and confirm safety. 

The current study will be followed by a randomised open label Phase 2 study involving around 68 patients with metastatic gastric cancer overexpressing HER2.  The study will be randomised into two arms of either HER-Vaxx plus standard-of-care (chemotherapy) or standard-of-care alone. The endpoints of this randomised trial will be safety, immune response, progression-free survival and overall survival.