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‘s-HERTOGENBOSCH, the Netherlands; September 25, 2024. Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, announces publication of the results of a phase II trial in resected pancreatic cancer (REACTIVE) in the Journal of Clinical Oncology (JCO).

Highlights from the REACTIVE trial in resected pancreatic cancer:

The phase II trial, including 38 patients with resected pancreatic cancer who had completed standard-of-care chemotherapy, met the primary endpoint demonstrating a clinically significant increase in 2-year recurrence-free survival of 64% compared to an expected 40%. This was accompanied with only low grade side effects.

The 2-year overall survival rate was 83%. Translational

Amphera announces publication of the positive results of the phase II trial in resected pancreatic cancer (REACTIVE) in the Journal of Clinical Oncology (ASCO), one of the world’s leading scientific journals.

The conclusion of the article: “This study reached its primary end point of a 2-year RFS rate of ≥60% following pancreatectomy after SOC treatment and adjuvant DC-based immunotherapy in patients with pancreatic cancer. These results warrant a future randomized trial.”

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

Amphera B.V., a late-stage biotechnology company developing MesoPher cell therapy to treat cancer, reports publication of the positive results of the phase II study of MesoPher in peritoneal mesothelioma (MESOPEC) in the Journal for ImmunoTherapy of Cancer.

Peritoneal mesothelioma is an aggressive cancer with a poor prognosis. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) improve survival, however, recurrence rates are high. 16 patients were treated with MesoPher as an adjuvant after HIPEC-CRS. Median progression free survival (PFS) was 12 months (IQR 5–23) and median overall survival (OS) was not reached. Median follow-up time for surviving patients was 26 months (IQR

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.

Topline results expected early Q4 2022

`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.