Northwest Biotherapeutics completes key development work for Flaskworks system

Northwest Biotherapeutics announced that the key development work for the Flaskworks manufacturing system has been completed and an external vendor has been engaged to produce GMP-grade units of the system. In addition, the patent coverage of the Flaskworks system has been expanded: the foundational patent has been issued in the U.S. and an additional new patent application has been filed. The Company believes that this broad patent coverage will help it build a strong franchise. The Company believes that the Flaskworks system will play a central role in enabling the efficient and timely scale-up of manufacturing to make DCVax-L products for large numbers of patients, and in reducing the manufacturing facility costs. The Company further believes that these efficiencies will be pivotal for enabling the DCVax-L platform to be affordable and potentially suitable for widespread use as a frontline therapy. As the Company has previously reported, including at its Annual Meeting in December 2022, the Flaskworks system has been under intensive development for a number of years. Several fundamentally differing approaches and system designs were developed, tested, modified and re-tested until the best one was determined. The next step is to have GMP-compliant versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. This process is expected to take several months, in part due to ongoing supply chain issues. As soon as the GMP-grade units are delivered, Advent BioServices will undertake final qualification and validation of the GMP units and use engineering runs with the system to collect data in order to submit an application to regulators to approve the use of the system for production of DCVax-L for patients. The Company is optimistic about this approach because the Flaskworks system now closely mirrors the existing manufacturing process, and the DCVax-L products manufactured through the Flaskworks system are substantially comparable to the DCVax-L products made through the existing manual process.