Proprietary immuno-oncology approach harnesses autologous dendritic cell therapy

`s-Hertogenbosch, The Netherlands, 21 May 2019. Amphera B.V., an advanced-clinical-stage biotechnology company developing dendritic cell therapies to treat cancer, announces that it has recruited the first patients to a phase II study of MesoPher to treat pancreatic cancer.

REACtiVe (Rotterdam pancrEAtic cancer Vaccination trial) is an open-label phase II study in 10 adult patients with surgically resected pancreatic cancer who have received adjuvant standard of care treatment.

MesoPher, a personalised immuno-oncology cell therapy, is comprised of autologous dendritic cells loaded with PheraLys, Amphera’s proprietary allogeneic lysate of mesothelioma cell lines. PheraLys, first developed for mesothelioma, contains a broad-spectrum of tumour-associated antigens, many of which are present in pancreatic cancer and other cancers.

MesoPher is currently in a pivotal phase II/III study for pleural mesothelioma, and a phase II study in peritoneal mesothelioma.

Ilona Enninga, COO of Amphera said: “Pancreatic cancer is an immunological “cold” tumour with poor infiltration of cytotoxic T-cells into the tumour. MesoPher has proven to be able to turn “cold” mesothelioma tumours “hot”, allowing T-cells and other components of the immune system to infiltrate the tumour. As mesothelioma and pancreatic tumours share numerous antigens, there is a strong scientific rationale to assess MesoPher in the treatment of pancreatic cancer. This study is designed to validate this principle, and if successful could offer a new therapeutic mechanism of action to treat the disease.”

Rob Meijer, CEO of Amphera said: “According to GLOBOCAN – The Global Cancer Observatory –  over 450,000 new cases of pancreatic cancer were diagnosed worldwide in 2018, with around 430,000 deaths.¹ Overall five-year survival rates for the disease in the U.S. are 9%.² As such, there is a clear unmet medical need for new treatments for pancreatic cancer.”

Prof. Casper van Eijck MD PhD, Department of Surgery at Erasmus MC, and lead investigator on the REACtiVe study said: “Pancreatic cancer patients have limited treatment options, resulting in low five-year survival rates even after surgery. As such we are excited to start this clinical study with MesoPher based on a sound immuno-oncology rationale, and which has the potential to bring a new treatment option to patients.”

Company contact:
Amphera
Rob Meijer (CEO) rob.meijer@amphera.nl
Ilona Enninga (COO) ilona.enninga@amphera.nl

Media contact:
80th Atom
Adam Michael
+44 1223 511338
+44 777 588 1813
Adam@80thAtom.com

Notes to Editors

About Amphera – www.amphera.nl
Amphera is an advanced-clinical-stage biotechnology company developing dendritic cell therapies to treat cancer. Amphera’s management team has extensive experience of building successful life science companies and creating high-value shareholder exit opportunities. The Company has three ongoing clinical programmes with MesoPher – its personalised immuno-oncology cell therapy, comprised of autologous dendritic cells loaded with PheraLys, its proprietary allogeneic lysate of cancer cell lines

The lead programme is in a pivotal phase II/III study in pleural mesothelioma – a cancer of the lining of the lungs. The second programme is a phase II study in peritoneal mesothelioma – a cancer of the lining of the abdominal cavity. Amphera has obtained FDA and EMA orphan-designation for MesoPher for mesothelioma. The third programme is in a phase II study in pancreatic cancer. Amphera is fully financed to complete its current three clinical development programmes.

About pancreatic cancer
Over 450,000 new cases of pancreatic cancer were diagnosed in 2018, with 430,000 deaths.[1] Overall five-year survival rates for the disease in the U.S. are 9%.[2] Pancreatic cancer is an immunological “cold” tumour, resulting in low infiltration of cytotoxic T-cells. Amphera’s approach to the disease will turn pancreatic tumours “hot”, allowing the infiltration of cytotoxic T-cells and other components of the immune system.

About REACtiVe (Rotterdam pancrEAtic Cancer Vaccination trial)
REACtiVe is an open label phase II study in 10 adult patients with surgically resected pancreatic cancer who have received adjuvant standard of care treatment. Patients will receive 3 bi-weekly injections of MesoPher, with potential two further injections of MesoPher at 4 and 7 months.

REACtiVe is an open label phase II study in 10 adult patients with surgically resected pancreatic cancer who have received adjuvant standard of care treatment. Patients will receive 3 bi-weekly injections of MesoPher, with potential two further injections of MesoPher at 4 and 7 months.

The primary objective of this phase II study is to investigate feasibility of an allogeneic tumour cell lysate (PheraLys) loaded onto autologous dendritic cells (MesoPher) in resected pancreatic cancer patients who received adjuvant standard of care treatment. The secondary objective of the study is to investigate safety and toxicity as well as immune-response of MesoPher in these patients.

About MesoPher
MesoPher is comprised of autologous patient dendritic cells (DCs) loaded with PheraLys. The process starts with collecting blood from patients using leukapheresis, a standardised hospital procedure. Patient monocytes are isolated from the leukapheresis product and differentiated ex vivo into immature DCs. The patient’s immature DCs are then loaded with PheraLys to create activated, mature DCs, capable of presenting key tumour-associated antigens (TAAs) to the immune system. On returning the activated DCs to the patient, they migrate to the lymph nodes, where they induce an immune response, including NK-cells, B- and T-cells, to attack the tumour.

In an earlier phase I/II study of MesoPher the product was very well tolerated and clinically active, with an immunological (T-cell) response induced in all patients. Furthermore, all patients benefitted from treatment, having stable disease or partial response on imaging. Overall survival results were encouraging and warrant further confirmation in the pivotal trial. Data from the study also demonstrated that MesoPher can turn “cold” tumours, with an immune suppressing environment, into “hot” tumours infiltrated with cytotoxic T-cells and other components of the immune system.

About PheraLys
Amphera developed a number of clinical grade mesothelioma cell lines, which have been extensively tested and characterised. These stable cell lines ensure an inexhaustible source of tumour cell derivatives of constant quality. PheraLys is the lysate of these cell lines that contains a broad-spectrum of tumour-associated antigens.

References

1. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries doi.org/10.3322/caac.21492
2. American Cancer Society. Cancer Facts & Figures 2019. Atlanta:American Cancer Society; 2019. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf

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