`S-HERTOGENBOSCH, Netherlands--(BUSINESS WIRE)--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. I would like to thank our investigators and the clinical study team for their exceptional efforts in keeping the study on track. We are now focused on database lock and subsequent statistical analysis.”
Rob Meijer, CEO of Amphera said: “This is another significant milestone in the development of MesoPher after the promising efficacy results in pancreatic cancer reported earlier this year. The DENIM study is designed to be pivotal following discussions with the regulators. We plan to report topline results early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorization Application in H1 2023, starting the process of bringing this new therapy to mesothelioma patients.”
The DENIM (DENdritic cell Immunotherapy for Mesothelioma) study is a randomised open-label Phase II/III study of patients with pleural mesothelioma. The objectives are to assess the efficacy and anti-tumour activity of MesoPher as maintenance treatment after chemotherapy. Patients received 3 bi-weekly injections of MesoPher, plus two further injections of MesoPher after 4 and 7 months. Patients in the control arm received best supportive care alone. The primary endpoint of the study is overall survival.
In Q4 2022, Amphera will also present the survival data of the expansion cohort of 28 patients in the Phase II REACtiVe study of MesoPher in resected pancreatic cancer. The promising results of the first cohort were recently published in the European Journal of Cancer (https://www.ejcancer.com/article/S0959-8049(22)00159-9/fulltext).
Notes to Editors
About Amphera - www.amphera.nl
Amphera is a late-stage biotechnology company developing cell therapies to treat cancer. MesoPher is comprised of autologous dendritic cells loaded with PheraLys, a lysate of tumour cell lines. PheraLys contains a broad repertoire of tumour-associated antigens, many of which are present in pancreatic cancer and other cancers.
Five clinical programmes are ongoing with MesoPher. The lead programme DENIM is a pivotal phase II/III study in pleural mesothelioma – a cancer of the lining of the lungs. The REACtiVe study is assessing MesoPher in resected pancreatic cancer. The REACtiVe-2 study assesses the safety and efficacy of a CD40 agonist in combination with MesoPher in patients with metastatic pancreatic cancer. In addition, MesoPher is investigated in abdominal mesothelioma and in pleural mesothelioma in combination with surgical resection. Amphera has obtained FDA and EMA orphan-designation for MesoPher for mesothelioma.
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