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.

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 pro > The observed safety and statistically significant efficacy are the foundation for further randomized clinical research with MesoPher in pancreatic cancer The 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, Netherlands--(BUSINESS WIRE)-- 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 phase II/III DENIM trial. In the phase II Reactive trial, patients with resected pancreatic cancer who had completed standard-of-care chemotherapy received 3 bi-weekly injections of Amphera’s MesoPher dendritic cell therapy and booster injections at 4 and 7 months. The Reactive trial met the primary endpoint with topline safety and efficacy data from two cohorts of in total 38 patients demonstrating a statistically significant 2-year Recurrence Free Survival of 60%. The results from the first cohort of 10 patients have been published in the European Journal of Cancer1. Based on these results, a 2nd cohort of 28 patients was fully enrolled. As established in all MesoPher trials, the safety pro excellent. Prof Casper van Eijck, Principal Investigator of the Reactive trial: We are thrilled by the promising results of the Reactive trial. These results exceed expectations for this group of patients compared to the best current treatments. A 60% 2-year recurrence free survival after surgical resection truly is an exceptional outcome. Further randomized clinical research with MesoPher in pancreatic cancer is a likely next step. In addition, we have seen that MesoPher induces a T cell response against the tumour of patients, which could explain the efficacy, although pancreatic cancer is known as a cold tumour. In the DENIM trial, mesothelioma patients with stable disease or better after platin-pemetrexed chemotherapy received either MesoPher maintenance treatment or best supportive care (BSC). The dosing scheme was identical to the Reactive trial. The DENIM trial confirmed MesoPher’s excellent safety pro MesoPher induced a robust T-cell response. The immune response did not translate into clinical benefit, and consequently the primary endpoint of an improvement of Overall Survival (OS) was not met. The unexpected outcome of the DENIM trial can be attributed to two main factors. The majority of patients were already progressive before or during the first 3 bi-weekly injections, as evidenced by the CT scan performed after the third injection. As such, the first injections were administered too late, as MesoPher cannot exert its effects in progressive patients. Only a small proportion of patients received the full MesoPher treatment. In addition, both arms performed well with a median OS around 18 months after randomization, potentially due to the second-line therapy with checkpoint inhibitors. Notes to Editors About Amphera - 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. References: European Journal of Cancer (22)00159-9/fulltext