Amphera’s MesoPher Cell Therapy Demonstrates Favourable Safety and Promising Survival in a Phase II Clinical Trial in Resected Pancreatic Cancer

`S-HERTOGENBOSCH, the Netherlands--(BUSINESS WIRE)-- 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, with 8 of 10 patients alive, which is far beyond expected survival. No disease recurrence or any tumour progression is seen in 7 of 10 patients. Remarkably, the 3 patients with disease recurrence did not demonstrate rapid tumour growth. Furthermore, the safety profile of the treatment was favourable, with only transient grade 1 and 2 adverse events.

Prof. Casper van Eijck, principal investigator on the study and author on the paper said: “These latest data should be interpreted with care, as they are from a small cohort of patients, without a control arm. Nevertheless, these are very promising results that are exceeding disease progression and survival expectations for this group of patients. We hope to confirm these observations in the expansion cohort, with first results anticipated in the fourth quarter of this year.”

Ilona Enninga PhD, COO of Amphera said: “Pancreatic cancer is notoriously challenging to treat, as the historical medical literature illustrates. In this paper, the investigators consistently identified activated T-cells against autologous tumour. We believe this mechanism of action of MesoPher, the ability to activate T-cells, is central to the efficacy signal we are observing.”

Rob Meijer, CEO of Amphera said: “We are very excited by this new data showing impressive survival in this challenging disease setting. It is worth noting that MesoPher has also demonstrated encouraging safety and efficacy Phase I/II data in mesothelioma, providing strong proof of concept for the application of MesoPher in multiple cancer indications. In the fourth quarter of this year, we will also see results from our pivotal Phase II/III DENIM study with MesoPher in mesothelioma next to the expansion cohort of the REACtiVe Phase 2 study.”

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. Amphera is fully financed to complete its current clinical development programmes.

References:

1. European Journal of Cancer https://www.ejcancer.com/article/S0959-8049(22)00159-9/fulltext

– ENDS –

View source version on businesswire.com: https://www.businesswire.com/news/home/20220504005575/en/