UK manufacturing facility & phase III trial updates from Northwest Biotherapeutics

Northwest Biotherapeutics , a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that an application for certification of the manufacturing facility in Sawston, UK has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). The Company also provided a process update on the DCVax®-L Phase III Trial.

On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce Good Manufacturing Practice clinical grade medical products for patients. This application represents the culmination of more than 2 years of preparations, including more than a year conducting these efforts under challenging COVID-19 restrictions and conditions.

As previously reported on March 16, 2021, the preparations have included the physical buildout of Phase I of the facility, development of over 500 regulatory documents (including Standard Operating Procedures (SOPs) for all aspects of operations, batch manufacturing records, and other formal documents), development of a Sawston team of nearly 40 persons with all of the required types of expertise for production of Advanced Therapy Medicinal Products (ATMPs) and training in regard to the DCVax® technology and processes.

The next step will be an on-site inspection of the facility by MHRA. Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA. Following completion of any actions, the Company is hopeful that an initial license will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3.

In addition to the MHRA submission activities, a prototype of the Flaskworks system has been delivered to the Sawston facility, and the Company currently anticipates that initial practice runs with the system may begin at the Sawston facility during the summer.

Meanwhile, manufacturing of vaccine products for compassionate use patients (“Specials”) has been and is continuing at the GMP facility in London.

The process outlined in the Company’s October 5, 2020 announcement relating to the Phase III trial of DCVax-L is continuing to move forward. The process includes review and analysis of the raw data by independent statisticians and experts, and preparation of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts in preparation for public announcement and scientific publication.

The Company continues to be in a quiet period while this process is under way. The Company appreciates shareholders’ patience, and their understanding that the Company cannot make partial disclosures during this process and cannot comment on the Phase III trial schedule or its data until the announcement of the results. We remain committed to completing the full plan outlined on October 5, 2020. PR Newswire