Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
07/06/2022 - 02:17 PM
Application Package Developed By Advent BioServices; Builds on Licenses Obtained in 2021
BETHESDA, Md. July 6, 2022 ® personalized immune therapies for solid tumor cancers, today announced that an application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). The application builds upon the 3 licenses received for the Sawston facility in 2021.
This application for a Manufacturer's license (MIA) represents the culmination of an additional year of intensive work, beyond the preparations over more than 2 years that were required for the applications for the initial licenses last year. The first license was received in September, 2021, from the Human Tissue Authority of the UK, and provided authorization for collection and storage of human tissues (such as the tumor tissue used to make the lysate for DCVax® -L products) and cells (such as the immune cells used to make DCVax-L). The second and third licenses were received in December, 2021, from MHRA, and provided authorization for manufacturing cellular therapies for use in clinical trials and compassionate use ("Specials") cases, respectively.
As reported last year, a further license from MHRA is required specifically for commercial manufacturing of cellular products. Application for a commercial license requires meeting even higher standards.
Preparations for this commercial license have included the creation of a further 50 standard operating procedures (SOPs) and policy and technical specification documents, validation of transport and shipping, and full validation and qualification of seven new pieces of equipment. Each step in such validation and qualification processes incorporates user requirement specification, design qualification, installation/operational qualification and performance qualification. This takes many months for each item of equipment. Additional controlled rate freezers were also procured, validated and qualified to expand the cryostorage capacity at the Sawston facility.
An automated system for the fill and finish of DCVax-L product has also been delivered, installed, validated and qualified. "Fill and finish" is the final step of the process, after a batch of DCVax-L product has been manufactured, in which the batch is allocated into single doses in individual vials for cryopreservation and distribution.
Preparations for this commercial license application have also included successful recruitment of additional highly experienced, senior-level GMP experts and scientists. There is a significant shortage of such senior experts throughout the cell and gene therapy sector, and such personnel are in extreme demand. These additions bring significant additional capacity and depth to the Sawston team.
As was the case before, the preparations for this license application have taken place in the context of ongoing supply chain problems, personnel shortages and other post-COVID obstacles. For example, delivery of necessary equipment has been delayed months beyond the scheduled delivery dates. Certain reagents that are required ingredients for DCVax-L have been subject to ongoing supply shortages, and there is an ongoing worldwide shortage of the special caps required for the cell culture flasks used to make DCVax-L. The cumulative effects of these and other individual delays and shortages have been, and continue to be, substantial.
The next step for this license application will be another on-site inspection of the Sawston facility by MHRA – this time, inspecting the facility, its procedures, personnel, regulatory documents, capacity and capabilities in accordance with the standards for commercial manufacturing. 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 post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end.
Such a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself. The Company has not to date submitted an application for commercial approval of DCVax-L.
Dr. Mike Scott , President of Advent Bioservices commented "Our Team has put in an extraordinary effort to meet our self-imposed, end of Q2 deadline to submit the MIA application. The standards set for the manufacturing of commercially licensed advanced medicinal therapies are understandably extremely stringent. We now await scrutiny of the application and processes by the MHRA, and are ready to welcome their inspectors to the Sawston facility."
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 has been completed and the top line data was presented by a key investigator at a recent scientific meeting. The Company is also pursuing development of DCVax® -Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and plans to prepare for Phase II trials as resources permit. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
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 enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the 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.
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SOURCE Northwest Biotherapeutics
