`s-Hertogenbosch, the Netherlands; 08 December 2021. Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, announces significant progress in its two clinical programs in pancreatic cancer as well as the full recruitment of all patients in its pivotal Phase II/III study in mesothelioma.
Based on a preliminary efficacy analysis of the first cohort of the REACtiVe study in resected pancreatic cancer patients, an expansion cohort has been completed at a remarkable pace with results expected in H2 2022. In total 26 patients are now included in the study. Safety and efficacy data from the first cohort of the REACtiVe study in resected pancreatic cancer patients treated with MesoPher have been submitted for publication by Erasmus MC, Rotterdam, the Netherlands.
In addition a study in metastatic pancreatic cancer, REACtiVe-2, has started recruiting patients. This study will assess the safety and efficacy of a combination therapy of MesoPher and mitazalimab (a CD40 agonist from Alligator Bioscience). This follows the strong preclinical data published in the Journal for ImmunoTherapy of Cancer, which established the potency of the combination (available here).
Finally, the company announces that the Phase II/III pivotal study DENIM in mesothelioma patients is fully recruited and confirms the readout to be expected in Q4 2022.
Rob Meijer, CEO of Amphera said: “Over the last year Amphera has made exceptional progress with its clinical development programmes based on its MesoPher cell therapy platform. Despite the challenging pandemic environment, our trials saw strong enrolment, underlying the high medical need for patients. The pivotal Phase II/III DENIM study in pleural mesothelioma has now been fully recruited with the read-out expected in Q4 2022 and we are strongly encouraged by the rapid enrolment of the expansion cohort of the Phase II REACtiVe study in pancreatic cancer. In addition to the studies in pancreatic cancer and pleural mesothelioma, efficacy of MesoPher is investigated in abdominal mesothelioma and pleural mesothelioma in combination with surgical resection.”
Prof. Joachim Aerts MD PhD, Medical Advisor to Amphera said: “Efficacy was first proven in mesothelioma and for me, as a clinician and a scientist, it is exciting to see that the previous efficacy found, translates into relevant clinical results for patients in other indications, especially one with a dire prognosis such as pancreatic cancer. We have also recently published highly compelling long-term survival data in Vaccines from three studies in mesothelioma patients (available here). In the three studies combined, the median overall survival was 27 months and the overall survival at 5 years was 21%. The expanding data set is showing the real potential of MesoPher in a wide range of oncology indications.”