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Thursday, August 11, 2022

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Heats Up as DCVax®-L Proves Safe & Effective While Sawston Facility Applies for Commercial Manufacturing License for Cellular Therapies

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has made a significant move northbound out of the trading channel where it was trading for the past few weeks since the stock was decimated due to a massive short attack helped along by Adam Feuerstein’s misleading article on Stat News. The move up comes after the Company reported its 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).  NWBO is targeting Glioblastoma multiforme (GBM) the deadliest, most treatment resistant cancers and the Company continue to see significant progress where all others have failed including many big names in biotech. 

NWBO is among the most exciting stocks in small caps. Recently the Company released the much-anticipated results of the Phase 3 clinical trial of DCVax®-L for GBM presented at NYAS on May 10 which showed significant improved overall survival. Patients treated with DCVax-L showed a clinically meaningful and statistically significant extension of survival, in both newly diagnosed and recurrent GBM. Primary endpoint was met (mOS in nGBM) with statistical significance, secondary endpoint met (mOS in rGBM) with statistical significance. The safety profile was excellent, with no autoimmune reactions and noteworthy long tails of survival. The stock has a significant short position that could fuel a massive short squeeze as NWBO continues to make progress. 

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) 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.  Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names recently who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. DCVax®-L has been featured by main stream press numerous times as many recovered patients have come forward crediting DCVax®-L for saving their lives. The stock represents easily among the highest risk-reward opportunities in the market today.  

NWBO 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.  

Northwest has an integrated strategy for protection of its technology through both patents and other mechanisms, such as Orphan Drug status. Currently the Company holds 204 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Of these, 191 issued patents and 52 pending patent applications directly relate to its DCVax products. In the United States and Europe, some of its patents and applications relate to compositions and the use of products, while other patents and applications relate to other aspects such as manufacturing and quality control. Additionally, with the acquisition of Flaskworks, Northwest gained ownership of a portfolio of patents and patent applications which include those held by Flaskworks as well as patents and patent applications exclusively licensed by Flaskworks from Northeastern University. The portfolio includes a total of thirteen patent families, with issued patents and pending applications worldwide. Collectively these patents and patent applications cover key aspects of the design and function of automated cell culture systems.   In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.  

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On July 6 NWBO reported 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.” 

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Currently trading at a $750 million market valuation NWBO has over $15 million in the treasury and is fully funded moving forward. NWBO is among the most exciting stocks in small caps. Recently the Company released the much-anticipated results of the Phase 3 clinical trial of DCVax®-L for GBM presented at NYAS on May 10 which showed significant improved overall survival. Patients treated with DCVax-L showed a clinically meaningful and statistically significant extension of survival, in both newly diagnosed and recurrent GBM. Primary endpoint was met (mOS in nGBM) with statistical significance, secondary endpoint met (mOS in rGBM) with statistical significance. The safety profile was excellent, with no autoimmune reactions and noteworthy long tails of survival. The stock has a significant short position that could fuel a massive short squeeze as NWBO continues to make progress moving forward. The stock recently broke northbound out of its trading range after the Company reported its 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).  NWBO is targeting Glioblastoma multiforme (GBM) the deadliest, most treatment resistant cancer and the Company continues to see significant progress where all others have failed including many of the biggest names in biotech. Microcapdaily first gave the heads up on NWBO on February 3, 2020 when the stock was $0.18 per share in our article: The Exciting Story of Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) We will be updating on NWBO as more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.

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