New data suggests high level of disease control possible with combination of dendritic cell therapy and PD-1/PD-L1 checkpoint inhibitors

`s-Hertogenbosch, The Netherlands, 3 April 2019. Amphera B.V., an advanced-clinical-stage biotechnology company developing dendritic cell therapies to treat cancer, presented data from patients that received a combination of its dendritic cell therapy product MesoPher with marketed checkpoint inhibitors, to treat mesothelioma. The data was presented at the AACR Annual Meeting 2019 in Atlanta, Georgia.

Dendritic Cells (DCs) capture, process, and present antigens to the immune system. However, mesothelioma suppresses the differentiation, maturation and therefore immuno-stimulatory function of DCs. Consequently, in most mesothelioma patients, the number of activated T-cells in the tumour is low. This may be one of the reasons checkpoint inhibitors have shown limited efficacy in mesothelioma.

Amphera’s DC therapy MesoPher has demonstrated that it can induce a T-cell response in mesothelioma, and therefore could enable checkpoint inhibitor therapy. Researchers at Erasmus MC, (Rotterdam, The Netherlands) have treated patients after DC therapy with checkpoint inhibitors (CI).

The key findings, presented at AACR, showed disease control rate of 88% in 9 patients exposed to treatment with radiological partial response in three patients, stable disease in five patients and only one patient with progressive disease as best response on CI therapy. No serious adverse events or severe toxicities were seen. The abstract can be found here.

Ilona Enninga, COO of Amphera said: “In a phase I/II study MesoPher demonstrated to be safe and clinically active in a stand alone setting. The latest data shows the potential additional therapeutic benefit when MesoPher is followed by treatment with checkpoint inhibitors, with promising survival rates and excellent safety.”

Rob Meijer, CEO of Amphera said: “It is our belief that Amphera’s unique approach to dendritic cell therapy that can turn ‘cold’ tumours with immune suppressing environment into ‘hot’ tumours infiltrated with cytotoxic T-cells, makes MesoPher an ideal component of combination treatment with checkpoint inhibitor in mesothelioma.”

MesoPher is currently being evaluated in a phase II/III study in pleural mesothelioma, a phase II study for peritoneal mesothelioma, and will start a further phase II study in 2019, in an undisclosed cancer indication.

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 preparation to enter the clinical phase in an undisclosed cancer indication. Amphera is fully financed to complete its current clinical development programmes.

About Pleural Mesothelioma
Pleural mesothelioma is a cancer of the lining of the lungs caused by inhalation of asbestos fibres. In Western countries about 13,000 mesothelioma deaths are reported annually and this number is increasing. There is only one therapy approved for the treatment of malignant mesothelioma, a combination chemotherapy of pemetrexed and cisplatin. Median survival with the best standard of care is 12 months after diagnosis.

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.

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