In the phase II Reactive trial in patients with resected pancreatic cancer, MesoPher demonstrated a statistically significant 2-year Recurrence Free Survival of 60% and an excellent safety profileThe observed safety and statistically significant efficacy are the foundation for further randomized clinical research with MesoPher in pancreatic cancerThe randomized phase II/III DENIM trial in mesothelioma patients was completed but missed its primary endpoint despite MesoPher inducing a robust T-cell response
‘s-Hertogenbosch, the Netherlands; December 12, 2022. Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, today reports topline results from both the phase II Reactive trial and the
Amphera is happy to announce that an article on the Reactive phase II trial in resected pancreatic cancer has been published in Data In Brief. The article describes a dataset from a proteomics analysis of tumor antigens shared between an allogenic tumor cell lysate vaccine and pancreatic tumor tissue.
`s-Hertogenbosch, The Netherlands; August 1, 2022. Amphera B.V., a late-stage biotechnology company developing cell therapies to treat cancer, announces that the last patient has completed the active follow-up in the Phase II/III DENIM study of MesoPher cell therapy to treat pleural mesothelioma.
Ilona Enninga PhD, COO of Amphera said: “Despite the challenges experienced during the pandemic, we were able to maintain strong enrolment to the study. The first patient was included in 2018, the last patient was included in June 2021 and completed the 12 month follow-up in June 2022. In total 176 patients were included.
Positive results from first cohort of 10 patients from REACtiVe study published in European Journal of Cancer
`s-Hertogenbosch, The Netherlands; May 4, 2022. Amphera B.V. announces positive REACtiVe Phase 2 study safety and efficacy data from the first cohort of 10 patients receiving Amphera’s MesoPher dendritic cell therapy. Patients, with resected pancreatic cancer who had completed standard-of-care chemotherapy, received 3 bi-weekly injections of MesoPher and booster injections at 4 and 7 months. The results from this first cohort have been published in the European Journal of Cancer1.
The latest REACtiVe data showed an average Overall Survival after surgery of approximately 36 months,
The ENSURE open label phase II trial (dENdritic cell therapy combined with SURgEry in mesothelioma) has enrolled the first patient. The objective of the study is to assess whether (neo)-adjuvant MesoPher dendritic cell therapy is feasible in resectable epithelioid pleural mesothelioma patients after first-line chemotherapy. The investigator initiated trial (link) will be performed at Erasmus Medical Center Rotterdam.
`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-2 trial will assess the safety and efficacy of CD40 agonist mitazalimab (Alligator Bioscience) in combination with MesoPher in patients with progressive metastatic pancreatic cancer. The first patient has been dosed in the phase I proof-of-concept trial that will enroll up to 18 patients. The investigator initiated trial will be performed at Erasmus Medical Center Rotterdam. The trial follows compelling pre-clinical data published in Journal for Immunotherapy of Cancer (Lau SP, et al. J Immunother Cancer 2020, link)
MesoPher is a personalised DC therapy consisting of autologous DCs loaded with PheraLys, Amphera’s proprietary allogeneic lysate of mesothelioma cell lines. PheraLys, first developed for mesothelioma, contains a broad repertoire of tumour-associated antigens, many of which are also present in pancreatic cancer and other cancers.
Preclinical results showed that DCs loaded with mesothelioma cell lysate can induce T-cell immunity and reduce tumour growth in mice with pancreatic cancer. In mice with established pancreatic cancer (mimicking the situation of non-resected pancreatic cancer patients) synergistic anti-tumour effects were achieved when DC vaccination was combined with a CD40-agonist. The DC/αCD40 combination therapy was
At the (virtual) 15th Meeting of the International Mesothelioma Interest Group (iMig2021), Bob Belderbos of Erasmus MC, The Netherlands presented a poster on the DENIM study. His contribution (P038) can be found here on p174.