MesoPher (Amphera)

‘S-HERTOGENBOSCH, The Netherlands--( BUSINESS WIRE )--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.

S-HERTOGENBOSCH, Netherlands--(BUSINESS WIRE)-- 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 significant 2-year Recurrence Free Survival of 60% and an excellent safety profile. 1) Notes to Editors About EMA Orphan Designation Source: “The EU offers incentives to encourage companies to research and develop medicines for rare diseases that otherwise would not be developed. To access these incentives, companies can apply for orphan designation for their medicine, provided certain criteria are met. Criteria for orphan designation: The medicine must treat, prevent, or diagnose a disease which is life-threatening or chronically debilitating, or it is unlikely that the medicine will generate sufficient returns to justify the investment needed for its development The disease must not affect more than 5 in 10,000 people across the EU No satisfactory method of diagnosis, prevention or treatment exists, or if such a method already exists, the medicine must be of significant additional benefit to those affected by the condition During an orphan medicine’s research and development, the company can benefit from incentives such as scientific advice on study protocols, various fee reductions and access to EU grants. Orphan-designated medicines that eventually make it to the market, and for which it can be demonstrated that they maintain the criteria for the designation, are granted 10 years of market exclusivity. Orphan designation is not an authorization: Not all orphan-designated medicines reach the marketing authorisation application stage. Those that do, are evaluated by EMA's Committee for Medicinal Products for Human Use (CHMP) using the same strict safety and efficacy standards that apply to all medicines evaluated by EMA.” About Amphera For more information: