NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Doc logic and Flipper44,

I think it is interesting to know that there is both a short version and a normal English version of the Fraunhofer IZI annual report 2017. The short version in particular is significant IMO.

SHORT VERSION 2017 P.27

PROJECT EXAMPLES

Manufacture of the immunotherapeutic DCVax®-L for brain tumor patients.

The manufacturing process for the immunotherapeutic DCVax®-L has been optimized and implemented as part of a clinical trial conducted by American biotech company Northwest Biotherapeutics, Inc. The therapeutic approach is based on autologous dendritic cells and aims to improve the treatment of glioblastoma, a particularly aggressive type of brain tumor.

https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/AnnualReport_IZI_2017_short.pdf

LONG VERSION 2017 P.28

PROJECT EXAMPLES

Manufacture of the immunotherapeutic DCVax®-L for brain tumor patients.

Until recently, Fraunhofer IZI spent several years manufacturing an investigational medicinal product for clinical trail in Germany and the UK, the efficacy of which is still being monitored as part of a phase III clinical trial.

American biotechnology company Northwest Biotherapeutics Inc. had previously succeeded in using the immunotherapeutic DCVax®-L in smaller clinical trials in the USA. This advanced therapy medicinal product (ATMP) is based on autologous dendritic cells and intended for the treatment of glioblastomas, a particularly aggressive type of brain tumor.

In order to manufacture DCVax®-L for each individual patient, tumor tissue and a blood product first had to be taken from the patient before the cell-based therapeutic agent could then be manufactured in a complex, multi-stage process. The number of patients that had to be recruited for the trial from a statistical perspective was reached back in 2015, marking the successful completion of the manufacturing and testing activities at Fraunhofer IZI.

However, as the therapeutic agent is being administered to the trial participants in several different doses over a threeyear period, cryopreserved clinical doses had to be sent to the participating clinical trail sites in 2017 for subsequent administration to the patients. This will also be the case in 2018, until the last scheduled dose is sent. We will then look forward to receiving the evaluation of the clinical trial from sponsor Northwest Biotherapeutics Inc.

https://www.izi.fraunhofer.de/content/dam/izi/en/documents/Publications/Annual_Report_IZI_2017.pdf