MesoPher is Amphera’s lead product to treat mesothelioma, a cancer of the lining of the lungs (pleural mesothelioma) or the lining of the abdominal cavity (peritoneal mesothelioma). MesoPher is currently in a phase II/III study to treat pleural mesothelioma.

MesoPher is comprised of autologous patient DCs loaded with “PheraLys” – Amphera’s allogeneic lysate of mesothelioma cell lines. While extraction of autologous DCs is a well-recognized practice, sourcing of autologous mesothelioma cells is highly invasive and is limited by the quality of biopsy material.

To circumvent these limitations, a number of clinical grade mesothelioma cell lines were developed. These cell lines have been extensively tested and characterized. The cell lines are stable and ensure an inexhaustible source of tumour cell derivatives of constant quality. PheraLys, the allogeneic lysate from these cell lines will be used in dendritic cell therapy for mesothelioma and other cancers.

MesoPher, autologous DCs loaded with PheraLys, is a personalized cellular product that is prepared for every individual patient. It is an Advanced Therapy Medicinal Product (ATMP). A robust, Good Manufacturing Practice (GMP) compliant production process including all relevant documentation is established and operational. The infographic below illustrates the straightforward steps to produce MesoPher for a certain patient.

Blood from a patient is collected via leukapheresis. This is a routine, standardized hospital procedure. From the leukapheresis product, monocytes are isolated and differentiated ex vivo (=outside the body) into immature DCs. These autologous (=from the patient) dendritic cells are loaded ex vivo with PheraLys, our proprietary allogeneic mesothelioma tumour cell lysate. Finally, the patient is treated with MesoPher, his/her own activated, mature dendritic cells.

Erasmus MC performed a phase I /II study with MesoPher. The key conclusions of the study are:

• MesoPher was very well tolerated and clinically active.
• In all patients an immunological (T-cell) response was induced.
• 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.
• The study demonstrated that DC therapy can turn ‘cold’ tumours with immune suppressing environment into ‘hot’ tumours infiltrated with cytotoxic T-cells and other cancer fighters.

Amphera has been granted Orphan Designation for MesoPher from both EMA and FDA. Scientific Advice had been obtained from EMA and FDA before designing the pivotal study.