Australia’s Imugene secures supply partnership with Merck and Pfizer

Pharma News: Imugene has advanced another treatment in its development pipeline through a clinical trial supply agreement with Merck Healthcare and Pfizer.

Australia’s Imugene announced a new clinical trial supply agreement with Merck and Pfizer to evaluate the safety and efficacy of Imugene’s HER-Vaxx, a B-cell activating immunotherapy, in combination with Bavencio (avelumab), an immune checkpoint inhibitor targeting PD-L1, in patients with HER-2 positive gastric cancer. Bavencio is co-developed and cocommercialised by Merck and Pfizer.

neoHERIZON is a Phase 2 clinical trial designed to assess the safety and efficacy of perioperative HER-Vaxx combined with chemotherapy with or without Bavencio 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.

“Imugene is excited to announce this collaboration. 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 Leslie Chong, Managing Director and Chief Executive Officer of Imugene. “Working together, we’re committed to finding ways to address the unmet needs of patients living with cancer.”

“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 Dr Dirk Arnold, Director of Asklepios Tumorzentrum, European School of Oncology.

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 and Pfizer will provide Bavencio for the duration of the study.