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‘S-HERTOGENBOSCH, The Netherlands

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 immune-profiling supports an induction of an effective immune-activation against the tumor.
• Patients in the REACTIVE trial received 3 bi-weekly injections of Amphera’s MesoPher dendritic cell therapy and booster injections at 4 and 7 months.

Prof Casper van Eijck, pancreatic cancer surgeon, Erasmus MC in Rotterdam and Principal Investigator of the REACTIVE trial said: “These results are promising as recurrence rates are high and long-term survival is rare in this patient group. We are now preparing a randomized phase II/III trial to replicate this efficacy signal. I am happy to announce that the DPCG, the Dutch Pancreatic Cancer Group, one of the world’s leading research groups in this field, has committed to participate in this trial.”

Ilona Enninga, COO of Amphera added “We have created a promising cell therapy bridgehead. MesoPher is derisked as to safety and manufacturing. This trial shows that MesoPher induces a clinically meaningful immune response, causing an increase in patient survival. EMA has granted MesoPher Orphan Designation for pancreatic cancer, based on potential significant benefit. We are very happy to announce today that the FDA has granted MesoPher Orphan Designation for pancreatic cancer as well.”

Rob Meijer, CEO of Amphera said “The potential of MesoPher cell therapy is increasingly recognized in the scientific and regulatory community. The JCO publication will certainly help us to realize the necessary funding and partners for our next step: a randomized trial in resected pancreatic cancer.”

About Amphera – http://www.amphera.nl

Amphera B.V., a late clinical-stage biotechnology company, develops MesoPher cell therapy for the treatment of cancer. Our lead indications are mesothelioma and pancreatic cancer. MesoPher is comprised of autologous dendritic cells loaded with our proprietary allogeneic tumour cell lysate PheraLys. PheraLys is a well-characterized, innovative source of a broad repertoire of Tumour Associated Antigens.

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