Berlin, 27 August 2009 – The patent office in the USA has decided to grant MOLOGEN AG the patent for cell-based gene therapy to treat cancer. This is a significant development for MOLOGEN with respect to the subsequent licensing of a further highly innovative product candidate. MOLOGEN’s key technologies MIDGE® and dSLIM® and a MOLOGEN cancer cell line are used in the cell-based gene therapy of cancer. Preparations are being made to apply for phase Ib/IIa clinical studies about the cell-based treatment of renal cancer for the product candidate MGN1601.

About cell-based gene therapy of cancer

The process developed by MOLOGEN to treat cancer with cell-based gene therapy involves therapeutic vaccination to combat metastasised tumours and to prevent reoccurrence (recidivation) of them after an operation, radiation and/or chemotherapy.

Human cancer cells that have been obtained from a tumour (e.g. a renal tumour) and are available in a standardised and characterised cell bank (master cell bank) form the basis for the vaccination. Cells that come from a single person, are established as a cell line and are used with other patients are known as allogenic cells.

The principle by which the cell-based gene therapy works is to induce a cross reaction of the immune system against patients’ own cancer cells, after the immune system has learned what cancer cells are typically like via the reaction against the allogenic cancer cells. In order to achieve this efficiently, the allogenic cancer cells are “genetically modified” with additional genetic information and are combined with MOLOGEN’s own DNA immune modulator dSLIM® as an adjuvant to maximise the effect of the vaccination before they are injected into the patient. The genetic modification is carried out with the help of the DNA-based MIDGE® vectors that have also been developed by MOLOGEN.

About MGN1601

The clinical application of cell-based gene therapy of renal cancer is being investigated by MOLOGEN as product candidate MGN1601. The basis here is a unique renal cancer cell line that MOLOGEN has established itself. MOLOGEN is currently preparing a phase I/II clinical study with MGN1601 which is of relevance for approval purposes and for which an application is to be submitted before the end of this year.

The cell-based gene therapy of renal cancer has been given orphan drug status by the European Medicines Agency (EMEA). Orphan drug status enables the product to be marketed exclusively within the European Union for ten years. In addition to this, the company receives comprehensive advice and support from the EMEA during the approval procedure at reduced cost. The purpose of the European Union’s orphan drug programme is to promote the development of treatment for rare and severe illnesses.