Northwest Biotherapeutics Acquires Flaskworks

Northwest Biotherapeutics announced the Company has acquired Flaskworks, a company that has developed a system to close and automate the manufacturing of cell therapy products such as DCVax®.

Flaskworks was previously owned by its technical founders and Corning Incorporated. The technical team from Flaskworks has joined NW Bio as part of the acquisition.

It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.

The Flaskworks system is designed to change the manufacturing process from artisan hand work to assembly line-like automation. As such, the Flaskworks system is designed to enable the scale-up to far greater production volumes. Technicians will oversee the automated systems (potentially multiple systems per technician) rather than making the products themselves.

The Flaskworks system is also expected to reduce production costs: turning "open" steps in the manufacturing process into "closed" steps, in which the product is not open to the air in the manufacturing suite, removing the need to build and operate the extremely costly clean room suites for those processes, and removing the need for personnel to work in sterile lab suits.

The buildout of the Sawston, UK facility has purposely been designed to proceed in phases, as modules, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. Implementation of the Flaskworks system will enable certain phases of the buildout to be simplified and streamlined.

The existing manufacturing process for DCVax-L products already takes a practical and economical approach by using a batch manufacturing process combined with special cryopreservation technology. The full set of doses for a patient, for as much as 3 years of treatments, are all produced in a single 8-day manufacturing batch, and then are stored frozen in single doses. The freezing technology has been validated and was used throughout the Company's Phase 3 trial. This makes DCVax-L an off-the-shelf product for the whole treatment period after the one-time manufacturing batch, while also being a fully personalized product.

The Flaskworks system will follow the same batch-manufacturing process – doing so in a "closed" and automated manner.

Certain optimization work will be required so that the Flaskworks system will produce DCVax-L products with characteristics equivalent to the products made by the current DCVax-L manufacturing processes. This will then need to be confirmed by comparability studies. The Flaskworks technical team will work with NW Bio's contract manufacturers to accomplish this. In the meantime, the Company's DCVax products will continue to be made through the existing processes.

The acquisition of Flaskworks was executed and closed on August 28, 2020. The total purchase price was approximately $4.33 million, of which $1.65 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting, and $0.67 million will be paid in either cash or stock, or a combination thereof, within 120 days after the closing.

The acquisition includes both intellectual property owned by Flaskworks and a license of additional intellectual property from Northeastern University.

"We believe that our DCVax platform technologies are potentially applicable to all types of solid tumor cancers, which comprise the vast majority of all cancers. We are working to build the infrastructure and systems that can enable the scale-up of production to such volumes – and can do so at a price level that will be affordable for widespread use of DCVax treatments," Linda Powers, NW Bio's CEO said.