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Tuesday, September 27, 2022

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is Heating Up as Biotech Begins Production of Dendritic Cell Cancer Vaccine at Sawston Facility & Phase III Top Line Data Looms

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is one exciting biotech that has given up some gains since hitting highs of $2.50 per share but not that much and is now making another strong move on $1 as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names in pharma who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. 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 and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range.  

NWBO is also making rapid progress on other fronts recently reporting commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”).  The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. Now that the facility is ready for the manufacture of cell therapy products for clinical use, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility. The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year.  

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotech 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. Northwest 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. 

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 199 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 US 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. In addition to its patent portfolio, Northwet has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.  

DCVax® is designed to reinvigorate and educate the immune system to attack cancers. Unlike conventional cancer drugs, which use one active agent to hit one target on the cancer, DCVax uses many active agents to hit many targets on the cancer. Northwest believes that at least three key aspects of the DCVax technology contribute to the positive results seen in clinical trials to date: (1) DCVax is designed to mobilize the entire immune system, not just one among the many different categories of immune agents in that overall system. 2) DCVax is designed to target not just one but the full set of biomarkers on the patient’s tumor. And 3) DCVax is personalized, and targets the particular biomarkers expressed on that patient’s tumor.  

NWBO has a strong management team behind it, led by CEO Linda F. Powers, a high-powered executive who served on the MD Stem Cell Research Commission, and was the Commission Chair for the first two years of the state’s stem cell funding program. Ms. Powers served for more than 6 years on the Board of the Trudeau Institute, as well as several years on the Steering Committee of the National Academy of Sciences, evaluating government research funding, and has been appointed to three Governors’ commissions created to determine how to build the respective states’ biotech and other high-tech industries. Ms. Powers also serves on the boards of a number of private biotech companies. The Company’s CSO, Alton L. Boynton used to be head of the Molecular Oncology research lab at the Pacific Northwest Research Foundation (the original foundation of Bill Hutchinson, from which the Fred Hutchinson Cancer Center was spun off). NWBO’s CTO, Marnix L. Bosch Ph.D. has led the processes for numerous regulatory submissions in both the U.S. and abroad and used to work at the Dutch National Institutes of Health (RIVM) as head of the Department of Molecular Biology, as well as in academia as a professor of Pathobiology. He has authored more than 40 peer-reviewed research publications in immunology and virology, and is an inventor on several patent applications on dendritic cell product manufacturing. 

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The DCVax technology is expected to be applicable to most cancers, and is embodied in several distinct product lines. One of the product lines (DCVax®-L) is designed to cover all solid tumor cancers in which the tumors can be surgically removed. Another product line (DCVax®-Direct) is designed for all solid tumor cancers which are considered inoperable and cannot be surgically removed. Management believes the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering. Importantly, DCVax has an excellent safety profile and is non-toxic. In clinical trials to date, stretching over a decade and including over 1,000 treatment cycles, there have been no toxicities such as chemotherapies involve – and not a single “serious adverse event” – related to the treatment.  

There have been indications that the top line date for DCVax®-L will be overwhelmingly positive; according to date published from 2018 at the Society for Neuro-Oncology Annual Meeting in New Orleans shows the following: Median overall survival (OS) from surgery in the intent-to-treat population at data cutoff was 23.1 months, the same OS benefit identified in 2017. The survival rate at year 2 was 46.4%, on par with 46.2% in 2017. In patients with methylated MGMT genes, median OS after surgery was 35.1 months, slightly better than 34.7 months observed in 2017. This represents a vast improvement over the median OS of only 14.6 months. “The survival rate is quite remarkable compared to what would be expected for glioblastoma,” said lead author Dr. Linda Liau, professor of neurosurgery at the David Geffen School of Medicine at UCLA and a member of the UCLA Jonsson Comprehensive Cancer Center. “The 20 to 30 percent of long-term survivors in immunotherapy clinical trials are the people in whom we think there may be a particularly strong immune response against their cancer that is protecting them from getting tumor reoccurrence.”   

NWBO is pursuing an intensive program of manufacturing preparations and planning in preparation of the top line data from its Phase III trial of DCVax®-L; development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and certified by the UK Medicines and Health Products Regulatory Authority (“MHRA”). The Sawston facility contains a total of 88,345 square feet on two floors.  The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. 

NWBO Sawston, UK advanced manufacturing facility

 

The last press release from NWBO came on February 17 when the Company reported commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK. This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility for compassionate use cases, and approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this regulatory program in the UK, the vaccine is identified as ADCV (“Autologous Dendritic Cell Vaccine”). 

As previously reported, the MHRA license was received in December of 2021, following nearly two years of preparations. This included hiring and training of technical staff, preparation of approximately 1,000 regulatory documents (including Standard Operating Procedure documents and others), validation of facilities, equipment and protocols, and practice manufacturing cycles. This was followed by a review and detailed inspection by the MHRA. 

Since the issuance of the MHRA license, Advent Bioservices, NW Bio’s contract manufacturer in the UK, has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use. Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility. The Company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year. The Company plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies such as the Flaskworks system. 

Microcapdaily first reported on NWBO on November 11, 2018 when NWBO was trading at $0.20 stating at the time: “Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has been sitting at around $0.20 as Investors wait out a news vacuum since the end of August. Northwest is an exciting Company with a recent history of explosive moves up. The stock used to trade at much higher levels. Currently trading at a $105 million market valuation NWBO has $1.6 million in the treasury, some revenues reporting $410,000 in revenues for the 6 months ended June 30, 2018 and significant debt on the books. Northwest is a really exciting company; their lead product, DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. This product in an ongoing Phase III trial for newly diagnosed Glioblastome multiforme (GBM).” 

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Currently trading at a $904 million market valuation NWBO has 981,374,858 shares outstanding out of 1.2 billion authorized. The Company is an SEC filer and fully reporting OTCQB. While the Company has $15.2 million in the treasury and over $40 million in assets, they also have significant debt on the books. NWBO is pre revenue but some have started to trickle in topping $1 million in sales in 2021. Northwest has been very successful raising money recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000. Speculation is sky high that NWBO is on the verge of major success where all others have failed including many big names in pharma who hail DCVax®-L as an effective treatment/cure for the deadliest, most treatment resistant cancers. There have been indications that the top line date for DCVax®-L will be overwhelmingly positive. 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 and if top line data is positive as many speculate it will be, there is no limit to how high NWBO can go. Positive results should provide Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder, which would readily be in the $10 to $20 billion market cap range. Microcapdaily first reported on NWBO on November 11, 2018 when NWBO was trading at $0.20 per share. We will be updating on NWBO when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with NWBO.

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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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