Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility

Rhea-AI Summary

Northwest Biotherapeutics (OTCQB: NWBO) has received a Manufacturing and Importation Authorization (MIA) license from the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at its Sawston, U.K. facility. This license, among the first of its kind in the U.K., enables global product export and is a significant step toward regulatory approval for NW Bio's lead product, DCVax®-L. Linda Powers, CEO, emphasized the milestone's importance for global operations, while Advent BioServices underscored the rigorous preparations that met high manufacturing standards over three years.

Positive

• Approval of MIA license enables global delivery of cell therapy products.
• This is one of the first licenses for commercial manufacturing of cell therapy products in the UK.
• License enhances NW Bio's operational capabilities for regulatory approval of DCVax®-L.

Negative

• None.

One of the First UK Licenses for Commercial Manufacturing of Cell Therapy Products;

Allows Global Delivery of the Products

BETHESDA, Md., March 20, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax^® personalized immune therapies for solid tumor cancers, and Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly announce that a MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K.

This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the companies' knowledge, there are only two other such licenses, one of which was just granted as well. 

This license is the culmination of more than 3 years' work, including development of the facility, the teams of specialized personnel, the Standard Operating Procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies in the Sawston facility for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NW Bio.

Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (e.g., immune cells) may also be imported into the U.K. for production or release of cell therapy products under the facility's licenses.

Linda Powers, CEO of NW Bio, commented, "We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K."

Dr. Mike Scott, President of Advent BioServices, commented, "It is always challenging to be one of the trailblazers. The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape. We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license."

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 results have been presented in scientific meetings and published in JAMA Oncology. 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. 

About Advent BioServices

Advent BioServices is a contract development and manufacturing organization (CDMO) based in Sawston, U.K. The Company operates the 88,000 square foot GMP facility in Sawston, which includes a large, HTA licensed, cryostorage facility capable of storing several million vials of tissues and cells, and includes capabilities for all stages of cell therapy development and production. During the past three-plus years, the Company has recruited staff members with a wide spectrum of specialist skills in the cell therapy space. The Process Development and QC teams provide significant expertise in complex assay development, GMP manufacturing, product release and GMP-related monitoring which has underpinned the work leading to MHRA licensing for commercial manufacturing, as well as the prior licenses for manufacturing for clinical trials and compassionate use (Specials).

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. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will be viewed as demonstrating 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.

CONTACTS
Northwest Biotherapeutics	Advent BioServices
Dave Innes	Philippe Piré
804-513-4758	917-796-2426
dinnes@nwbio.com	ppire@adventbio.uk
Les Goldman
240-234-0059
lgoldman@nwbio.com

 

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SOURCE Northwest Biotherapeutics

FAQ

What is the significance of the MIA license for Northwest Biotherapeutics (NWBO)?

The MIA license allows NWBO to commercialize its cell therapy products globally, marking a major milestone in its development.

When was the MIA license for NWBO approved?

The MIA license was approved on March 20, 2023.

What are the future plans for NWBO after receiving the MIA license?

NWBO plans to use the license to pursue regulatory approval for its lead product, DCVax®-L.

Where is Northwest Biotherapeutics' manufacturing facility located?

The manufacturing facility is located in Sawston, U.K.