Bio-tech company Imugene (ASX: IMU) has announced a new clinical trial supply agreement to evaluate the safety and efficacy of Imugene’s HER-Vaxx, a therapeutic cancer vaccine for the treatment of gastric cancer.
HER-Vaxx is a B-cell activating immunotherapy, in combination with avelumab, an immune checkpoint inhibitor targeting PD-L1, in patients with HER-2 positive gastric cancer. Avelumab, which is marketed as BAVENCIO®, is co-developed and cocommercialised by Merck KGaA, Darmstadt, Germany and Pfizer Inc, who will evaluate the vaccine.
The study’s primary endpoint is pathologic complete response. Secondary endpoints include safety and biomarker evaluation.
“We are very excited for the opportunity to treat patients with this new generation of HER-2 targeted Bcell immunotherapy, which has the potential to address significant unmet need in early HER-2 overexpressing gastric cancer that remains a challenging indication with poor prognosis," said Dirk Arnold, director of the Asklepios Tumorzentrum in Hamburg.
"The combination of chemotherapy and HER-Vaxx alone or in combination with avelumab in this type of gastric cancer may support a better treatment outcome for patients."
"HER-Vaxx has shown a tolerable safety profile and encouraging efficacy in patients with metastatic HER-2 positive gastric cancer, and we are looking forward to evaluating HER-Vaxx with avelumab in the perioperative clinical setting,” said Imugene CEO Leslie Chong.
“Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer.”
Under the terms of the agreement, Imugene will be the sponsor of the study and will fund the clinical study from existing budgets and resources. Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for the duration of the study.
Shares in Imugene (ASX: IMU) are trading 5.2 per cent higher at $0.605.