S-HERTOGENBOSCH, the Netherlands; June 5, 2023. Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, today announces that the EMA Committee for Orphan Medicinal Products (COMP) has recommended the granting of orphan medicinal product designation for MesoPher in pancreatic 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.
In December 20221, Amphera reported topline results from the phase II REACTIVE trial in patients with resected pancreatic cancer. MesoPher demonstrated a statistically
REACTIVE-2 is assessing the safety and immunological effect of mitazalimab in combination with MesoPher in metastatic pancreatic cancer
Mitazalimab and MesoPher have both achieved positive results in separate Phase 2 clinical studies in pancreatic cancer
Preliminary results of REACTIVE-2 are expected in Q4 2023
Lund, Sweden, and ‘s-Hertogenbosch, the Netherlands, April 26, 2023 – Alligator Bioscience AB (“Alligator”) (Nasdaq Stockholm: ATORX) and Amphera B.V. (“Amphera”) today announce the successful dosing of the last patient in the REACTIVE-2 Phase 1 trial evaluating mitazalimab in combination with MesoPher in patients with metastatic pancreatic cancer.
The open-label, single-center Phase 1 dose finding study is assessing the safety
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)