Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, today announces publication of the results of the phase II/III trial in pleural mesothelioma (DENIM) in The Lancet Oncology, one of the world’s leading scientific journals.

Highlights from the DENIM trial in pleural mesothelioma:

• In the DENIM phase II/III trial, mesothelioma patients with stable disease or better after platin-pemetrexed chemotherapy received either MesoPher maintenance treatment or best supportive care.
• Although the study was negative for its primary endpoint of overall survival for all patients, the data reveal important subgroups of patients who had clinically meaningful benefit from MesoPher treatment.
• Analysis revealed that two-thirds of the patients had disease progression before or shortly after the start of MesoPher therapy, the other one-third did have a clinically meaningful benefit in progression free survival.
• MesoPher cell therapy induced CD4 T cell responses correlated to clinical responses.
• The DENIM trial confirmed the excellent safety profile of MesoPher cell therapy.

Prof Joachim Aerts, PI of the DENIM trial in mesothelioma, head of the Department of Pulmonary Medicine, Erasmus MC, Rotterdam, inventor of MesoPher and medical advisor to Amphera said: “As vaccines are less effective in patients with progressing cancer, we have to conclude that the study procedures before the start of the treatment were too long. Analysis of clinical results, combined with the induced broad immune response and the signs of efficacy in subgroups, strengthen our view that the study design failed the product and not vice versa. We have identified several options to shorten the treatment lead time”

Rob Meijer, CEO of Amphera added “On short notice, we expect publication of the exceptionally positive results of the phase II clinical study in resected pancreatic cancer (REACTIVE) in another leading scientific journal. We are thrilled with the publication of MesoPher clinical data in these high-ranking scientific journals, as this supports our endeavor to attract finance and partners and to bring this therapy to patients as fast as possible.”