Amphera recruits first patients to pivotal phase II/III study of MesoPher to treat pleural mesothelioma
Proprietary immuno-oncology approach harnesses autologous dendritic cell therapy to treat an orphan-designated cancer
`s-Hertogenbosch, The Netherlands, 18 March 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 its pivotal phase II/III study of MesoPher to treat pleural mesothelioma, a rare cancer of the lining of the lungs.
DENIM (DENdritic cell Immunotherapy for Mesothelioma) is an open-label, randomised, phase II/III study in 230 adults with pleural mesothelioma, to assess the efficacy and anti-tumour activity of MesoPher as maintenance treatment after chemotherapy. Patients in Arm A will receive 3 bi-weekly injections of MesoPher with best supportive care, plus two further injections of MesoPher at weeks 18 and 30. Patients in Arm B will receive best supportive care alone. The primary endpoint of the study is overall survival. Six mesothelioma referral centers in five European countries are participating in the DENIM study that has received funding from Horizon 2020, the European Union’s research and innovation programme.
Rob Meijer, CEO of Amphera said: “The number of pleural mesothelioma patients is on the rise and to date there is only one therapy registered with limited clinical benefit. As such, new approaches to treating mesothelioma are much needed to improve the prognosis for these patients.”
Ilona Enninga, COO said: “We are delighted to announce that the first patients have been recruited in our pivotal study. For Amphera the start of the study is a major milestone in our strategy to bring our dendritic cell therapy to patients. Based on this study we intend to draft the EMA Marketing Authorisation Application to register the therapy.”
MesoPher is also in a phase II study for peritoneal mesothelioma, and will start a further phase II study in 2019, in an undisclosed cancer indication.
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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.
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.
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.