Manufacturing immunotherapeutics for the treatment of brain tumors – preliminary study results published
Between 2011 and 2017, the Fraunhofer Institute for Cell Therapy and Immunology assisted American biotech company Northwest Biotherapeutics, Inc. in the conduct of a phase three clinical trial investigating the efficacy of the new DCVax®-L cell therapy in the treatment of glioblastomas. Fraunhofer IZI was responsible for preparing the investigational medicinal products for the European part of the trial. On May 29, 2018, the company published initial clinical findings in the Journal of Translational Medicine.
Before it could get up and running, in 2012 the Main Department of GMP Cell and Gene Therapy first had to transfer the GMP process for the DCVax®-L immunotherapeutic, which is based on autologous dendritic cells, and obtain the manufacturing authorization specifically required for this process pursuant to Section 13 of the German Drug Act (Arzneimittelgesetz, AMG). From this point on, the investigational medicinal products were manufactured in the clean rooms of Fraunhofer IZI in Leipzig for the European part of the trial, which covers study centers in Germany and the UK. The published results give reason to assume that the therapy is having a positive impact on patient survival rates, with the median overall survival time of the 331 patients examined increasing from an expected 15-17 months to an average of 23.1 months, and with 100 of the 331 patients showing median survival of 40.5 months. The personalized therapy also showed a good tolerability profile.
“The data is to be viewed as preliminary for the time being,” explains Linda Power, CEO of the company behind the drug, Northwest Biotherapeutics, Inc. “The study is still ongoing and all of the data remain blinded at present. The results may still change for the better or worse by the end of the study and following the final analysis. In view of the little progress made in treating glioblastomas over the past few years, these results are, however, encouraging.”
The autologous immunotherapy DCVax®-L is based on dendritic cells. These cells play a central role in regulating the immune system. As tumor tissue evolves from the body's own cells, it is often not recognized as foreign by the immune system and therefore not attacked. Through the DCVax® procedure, the dendritic cells are “educated” to recognize certain tumor antigens (biomarkers) which may only exist on the tumor cells. The modified cells subsequently stimulate T cells and additional mechanisms within the immune system to fight the respective tumor cells.
The original publication can be retrieved by following the link below.