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Imugene to Begin Phase II Trial of B-Cell Immunotherapy in HER2-Postive Gastric Cancer

NEW YORK – Imugene said on Tuesday it would begin a Phase II trial of its B-cell activating immunotherapy HER-Vaxx in combination with checkpoint inhibitor avelumab (Merck KGaA/Pfizer's Bavencio) and chemo in patients with HER2-positive gastric or gastroesophageal junction cancer.

The randomized, open-label trial, called neoHERIZON, will assess HER-Vaxx in combination with chemotherapy with or without avelumab in these patients. The primary endpoint of the study is pathologic complete response and secondary endpoints include safety and biomarker evaluation.

Imugene previously studied HER-Vaxx with chemotherapy alone in HER2-positive advanced gastric cancer in a Phase Ib study. The Phase II study will be sponsored and funded by Imugene, and Merck KGaA and Pfizer will provide avelumab for the duration of the trial.

"HER-Vaxx has shown a tolerable safety profile and encouraging efficacy in patients with metastatic HER2-positive gastric cancer, and we are looking forward to evaluating HER-Vaxx with avelumab in the perioperative clinical setting," Imugene CEO Leslie Chong said in a statement.

Imugene, based in Sydney, has several other B-cell activating immunotherapies and oncolytic virus therapies in development, including studies in non-small cell lung cancer, triple-negative breast cancer, and mixed advanced solid tumors. In May, Imugene licensed an oncolytic virus program targeting CD19 from City of Hope.