The Charité - Medical University of Berlin has today begun the implementation of the clinical study phase I/II with the renal cancer medication MGN1601 (ASET Study). With this MOLOGEN AG product, an innovative cell-based gene therapy for the treatment of advanced renal cancer is entering the first important test phase.
MOLOGEN AG, which has since the outset been building its research activities on a diversified product pipeline, has also achieved a decisive milestone in an additional product segment with the start of the clinical study for the renal cancer medication MGN1601.
The primary goal of this study is the investigation of the safety and tolerability of the medication. In addition effectiveness data is recorded, which contain the clinical, immunological and radiological parameters of the patients.
As a leading research company in DNA medicine and cell-based medicine, MOLOGEN AG is consistently pursuing its goal of developing highly effective and safe medications for the treatment of cancer illnesses.
The procedures developed by MOLOGEN AG for cell-based gene therapy against renal cancer involve a therapeutic vaccination to combat advanced tumors of the kidneys and the prevention of their reappearance after operations and medical treatment.
The basis of the therapy is human renal cancer cells. MOLOGEN itself has established a unique renal cancer cell line for this purpose. These cancer cells which are foreign (allogenic) for the patient are "gene-modified" with the help of MIDGE DNA vectors with additional genetic information and combined with MOLOGEN's own DNA immune modulator dSLIM as effectiveness enhancer (adjuvant).
The active principle of the cell-based gene therapy consists of provoking a cross-reaction of the immune system of the patients against their own cancer cells after the immune system has learned by the reaction against the gene-modified, foreign cancer cells how cancer cells typically appear. In preclinical investigations, the preparation has already exhibited outstanding tolerability and effectiveness.
Dr. Marina Tschaika, director of the clinical development department at MOLOGEN AG, explains: "With MGN1601 we hope to have developed a cancer therapy with few side effects, which will lead to long-term relief of cancer suffering and, at the same time, to a clear improvement in the quality of life for patients with advanced renal cancer. I am convinced that we are on the right track with this".
The clinical study is being directed by Dr Steffen Weikert, assistant director of the clinic for Urology at the Charité of Berlin.
PD Dr Steffen Weikert, an expert in the area of renal cancers, comments about the start of the study: "The ASET study with the preparation MGN1601 is an extremely interesting and promising study for us, because it builds on an advanced concept of therapeutic vaccination against renal cancer cells. We hope to continue to improve the prognosis for patients with advanced renal cancer with this therapeutic approach. This study will also open up to our patient perspectives for a better quality of life since the vaccination can be considered as low in side effects according to the current state of the art. We are pleased that the first patients can now be accepted for the study at Charite."
Renal cancer is the most frequently occurring malignant tumour of the kidneys with 200,000 incidences annually throughout the world. According to the Robert Koch Institute, there are 15,000 patients affected with this illness in Germany alone. Among these patients around 30% already have distant metastases at the time of initial diagnosis, which significantly reduces the success of a therapy. The tumor is known for not responding to radiation or chemotherapy. The use of preparations which are currently available on the market are accompanied by considerable side effects. Therefore a great medical need still exists for new, effective medications with low side effects for the treatment of renal cancer. With MGN1601, this approach is precisely followed.
The cell-based gene therapy against renal cancer has received the Orphan Drug Status from the European Medical Agency (EMA). This allows MOLOGEN AG to have a 10-year marketing exclusivity of the product within the European Union. The Orphan Drug Program of the European Union should promote the development of therapies for rare and serious illnesses.