Imugene (ASX: IMU) has signed new clinical trial supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc.
The agreement covers the evaluation of the safety and efficacy of Imugene’s HER-Vaxx, 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 co- commercialised by Merck KGaA, Darmstadt, Germany and Pfizer Inc.
neoHERIZON is an open-label, multi-centre, randomised, Phase 2 clinical trial designed to assess the safety and efficacy of perioperative HER-Vaxx combined with chemotherapy with or without avelumab compared to chemotherapy alone in patients with HER-2 positive gastric or gastroesophageal junction adenocarcinomas.
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 B- cell 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. 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 ” said Dirk Arnold M.D., Ph.D., Director of the Asklepios Tumorzentrum in Hamburg.
Leslie Chong, Managing Director and CEO of Imugene, said HER-Vaxx has shown a tolerable safety profile and encouraging efficacy in patients with metastatic HER-2 positive gastric cancer.
“We are looking forward to evaluating HER-Vaxx with avelumab in the perioperative clinical setting,” he said “Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer.”
Effective immediately, 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.
About Gastric and Gastro-esophageal Cancer
Perioperative (pre- and post-surgery) treatment in gastric or gastro-esophageal cancer remains an unmet need for patients with HER-2 positive tumours. The current standard of care is limited to chemotherapy, radiotherapy, and surgery when gastric cancer is diagnosed in its early stages.
Immune checkpoint inhibitors have been successfully introduced to metastatic gastric cancer. Moving HER-Vaxx into earlier gastric cancer in combination with chemotherapy or an immune checkpoint inhibitor may improve treatment outcomes for patients with this difficult to treat cancer.
Imugene’s HER-Vaxx is a B-cell peptide cancer immunotherapy designed to treat tumours that over- express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers. The immunotherapy is constructed from several B cell epitopes derived from the extracellular domain of HER-2/neu. It has been shown in pre-clinical studies and in Phase 1 and 2 studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target.