Northwest Biotherapeutics Announces HTA License Issued and MHRA Inspection Conducted for Sawston, UK Facility
BETHESDA, Md., October 28, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced the completion of two key milestones which are required for production of DCVax products at the Company’s manufacturing facility in Sawston, UK, and which have been a major focus since the completion of initial construction last year.
First, a license to work with human tissues for medical products at Sawston has been issued by the UK Human Tissue Authority (HTA) to the Company’s contract manufacturer and operator of the facility, Advent BioServices. Second, the comprehensive regulatory inspection of the facility has been conducted by the UK Medicines and Health Products Regulatory Authority (“MHRA”).
In the UK, an HTA license is required for the collection, processing and storage of human tissues and cells for medical purposes. This includes the tumor tissues used to prepare the lysate for DCVax-L products, and the immune cells that comprise the active ingredient of DCVax-L. Obtaining such a license requires an application, inspection and certification process. This process has now been completed and the HTA license allowing the relevant activities to be conducted at Sawston for DCVax-L has been issued.
The Sawston facility must also be certified and licensed by MHRA in order to be able to manufacture products such as DCVax-L. The process involves an extensive application process, comprehensive inspection of all aspects of the physical facility, its construction and equipment, and all aspects of the facility’s operations, including all operating systems, flow of materials and activities, sterility, quality control, staffing and other factors. It also includes extensive scrutiny of the quality management system that comprises approximately 1,000 regulatory documents, including standard operating procedures (SOPs) for the facility and for the product, validation records, data from practice manufacturing runs and other required documents.
Intensive preparations have been under way all year for this comprehensive inspection. A detailed application package and data were submitted to MHRA to qualify for the inspection. The original inspection timing was delayed by MHRA due to their caseload; however, the week-long onsite review by two MHRA inspectors was recently completed. The final phase of the process involves receiving an official MHRA inspection report and taking any responsive actions that may be required. The Company currently anticipates that this process will be completed before year-end.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial reached data lock and the Company is actively continuing to move toward announcement of top line data. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.