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Sunday, April 18, 2021

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Gaining as Phase III trial of DCVax®-L. Top Line Data Looms

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is once again in full beast mode skyrocketing up the charts on a massive surge of volume as investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is high that NWBO is on the verge of success where all others have failed. Including some very big names very recently; NWBO has an effective treatment/cure for the deadliest, most treatment resistant cancers.

Northwest recently reported Data Lock for the Phase III trial of DCVax®-L for Gliobastoma. This comes after a long 13 – year wait for investors. Expectations are sky high as we wait for top line data from the Phase III trial of DCVax®-L. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 expanding at a CAGR of 12.6% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products. 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.

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables the Company to produce its personalized vaccine in an efficient, cost-effective manner. The Company has a broad platform technology for DCVax dendritic cell-based vaccines. NWBO owns a valuable patent portfolio of 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families.

Very recently NWBO made a big step forward in its path to drug approval was the “unblinding” of its 15-year trial for DCVAX-L. On Oct. 5, the company issued a press release detailing many steps that would ensue, including the unblinding of the company’s management of the results of the statistical analysis of the data. According to the pr from NWBO: With the database now locked, the independent service firms managing the Clinical Trial are arranging for the independent statisticians to have access to the unblinded raw data from the Trial. Neither the Company nor any party other than the independent statisticians will have access to any unblinded data at this stage.

Earlier this year NWBO acquired Flaskworks, a company that has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax®.  Flaskworks was previously owned by its technical founders and Corning Incorporated.  The technical team from Flaskworks has joined NW Bio as part of the acquisition. It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.

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To date, the manufacture of immune cell therapies (including T cell therapies and others) has involved two major challenges.  First, the manufacturing processes involve “open” steps in which the product is open to the air in the manufacturing suite.  This necessitates extremely expensive “clean room” facilities with specialized infrastructure and specialized operating systems for sterile air and water, and personnel working in sterile lab suits (“space suits”).  Second, the manufacturing processes are mostly manual processes – in essence, hand crafted artisan processes by highly skilled technicians working under sterile conditions.

The Flaskworks system is also expected to significantly reduce production costs: turning “open” steps in the manufacturing process into “closed” steps, in which the product is not open to the air in the manufacturing suite, removing the need to build and operate the extremely costly clean room suites for those processes, and removing the need for personnel to work in sterile lab suits.  This will greatly reduce the DCVax-L production costs.  The buildout of the Sawston, UK facility has purposely been designed to proceed in phases, as modules, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage.  Implementation of the Flaskworks system will enable certain phases of the buildout to be simplified and streamlined.

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NWBO is once again in full beast mode skyrocketing up the charts on a massive surge of volume as investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is high that NWBO is on the verge of success where all others have failed. Including some very big names very recently; NWBO has an effective treatment/cure for the deadliest, most treatment resistant cancers. Northwest recently reported Data Lock for the Phase III trial of DCVax®-L for Gliobastoma. This comes after a long 13 – year wait for investors. Expectations are sky high as we wait for top line data from the Phase III trial of DCVax®-L. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 expanding at a CAGR of 12.6% during the forecast period, driven by rising geriatric population, growing incidence cases and rich clinical pipeline of new products. 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. 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 in 2018 and alerted investors on September 4, 2020 just as NWBO was taking off northbound. 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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