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`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.

Dr Bob Belderbos presented the DENIM study as clinical trial in progress at the virtual WCLC2020. The title of his presentation was: P24.03 – A Multicenter Randomized Phase III Trial of Dendritic Cell Maintenance Therapy After Chemotherapy in Mesothelioma; Denim Trial. The abstract can be found here.

An article on the DENIM study was recently published in Translational Lung Cancer Research: http://tlcr.amegroups.com/article/view/29434

Proprietary immuno-oncology approach harnesses autologous dendritic cell therapy

`s-Hertogenbosch,
The Netherlands, 21 May 2019. Amphera B.V., an advanced-clinical-stage
biotechnology company developing dendritic cell therapies to treat cancer,
announces that it has recruited the first patients to a phase II study of
MesoPher to treat pancreatic cancer.

REACtiVe
(Rotterdam pancrEAtic cancer Vaccination trial) is an open-label phase II study
in 10 adult patients with surgically resected pancreatic cancer who have
received adjuvant standard of care treatment.

MesoPher, a personalised immuno-oncology cell therapy, is comprised
of autologous dendritic cells loaded with PheraLys, Amphera’s proprietary
allogeneic lysate of mesothelioma cell lines. PheraLys, first developed for
mesothelioma, contains a broad-spectrum of tumour-associated antigens,
many of

Amphera is one of the ten winners of the Academic Startup Competition. This was announced by a professional jury in Amsterdam in the presence of State Secretary for Economic Affairs and Climate, Mona Keijzer.

As a result of the selection, Amphera will be able to pitch at the Global Entrepreneurship Summit (GES) and will be offered a trip to Silicon Valley by the Ministry of Economic Affairs and Climate Change. The GES will give Amphera the opportunity to learn how to scale up their innovation faster and take the step from startup to scale-up.

The 10 winners of the Academic Startup

New data suggests high level of disease control possible with combination of dendritic cell therapy and PD-1/PD-L1 checkpoint inhibitors

`s-Hertogenbosch, The Netherlands, 3 April 2019. Amphera B.V., an advanced-clinical-stage biotechnology company developing dendritic cell therapies to treat cancer, presented data from patients that received a combination of its dendritic cell therapy product MesoPher with marketed checkpoint inhibitors, to treat mesothelioma. The data was presented at the AACR Annual Meeting 2019 in Atlanta, Georgia.

Dendritic Cells (DCs) capture, process, and present antigens to the immune system. However, mesothelioma suppresses the differentiation, maturation and therefore immuno-stimulatory function of