MesoPher Cell Therapy Boosts 2-Year RFS in Resected Pancreatic Cancer; Phase II Results Published and Orphan Status Granted

Amphera B.V., a biotechnology company based in 's-Hertogenbosch, The Netherlands, announced the publication of promising results from a phase II trial investigating their MesoPher cell therapy in treating resected pancreatic cancer. The findings were published in the prestigious Journal of Clinical Oncology (JCO).

The phase II trial, known as REACTIVE, was led by Prof. Casper van Eijck, a pancreatic cancer surgeon at Erasmus MC in Rotterdam. Van Eijck emphasized the significance of the results, noting that recurrence rates for pancreatic cancer are typically high, and long-term survival remains rare for this patient group. He revealed that preparations are underway for a randomized phase II/III trial to confirm the efficacy of MesoPher. The Dutch Pancreatic Cancer Group (DPCG), a leading research organization in this domain, has committed to participating in the upcoming trial.

Ilona Enninga, the Chief Operating Officer (COO) of Amphera, highlighted the company's progress, stating that the MesoPher cell therapy has shown promise in terms of safety and production. The trial demonstrated that MesoPher induces a significant immune response, leading to increased patient survival rates. Enninga also announced that the European Medicines Agency (EMA) has granted Orphan Designation to MesoPher for pancreatic cancer, recognizing its potential benefits. Additionally, the U.S. Food and Drug Administration (FDA) has now also granted Orphan Designation for MesoPher in the treatment of pancreatic cancer.

Rob Meijer, the Chief Executive Officer (CEO) of Amphera, shared his optimism regarding the increasing recognition of MesoPher cell therapy within the scientific and regulatory communities. He believes that the publication in the Journal of Clinical Oncology will aid in securing the necessary funding and partnerships for the next phase of their research—a randomized trial focusing on resected pancreatic cancer.

Amphera’s announcement underscores the potential of MesoPher cell therapy to address a critical need in pancreatic cancer treatment, where effective long-term solutions are currently limited. The company’s forthcoming trial, backed by significant support from both European and American regulatory bodies, aims to further validate the initial promising outcomes and potentially pave the way for a new therapeutic option for pancreatic cancer patients.