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DCVax®-L Phase III Top-Line Data Imminent; the Rise of Northwest Biotherapeutics, Inc (OTCMKTS: NWBO)

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has rocketed past the $1 mark after the Company announced Data Lock for the Phase III trial of DCVax®-L for Gliobastoma Now the statisticians are proceeding with analyses of the raw data and preparing summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication. This comes after a long 13 – year wait for investors.

Expectations are sky high for DCVax-L; unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 as NWBO are well aware of. A cornerstone of NWBO expanding program is completion of the Phase I buildout of the Sawston, UK manufacturing facility.

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.”  The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers.  It has completed a 40-patient Phase I trial, and is preparing for 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.

NWBO lead produt DCVax-L is made with cancer antigens from tumor lysate from the patient’s own tumor tissue. As such, DCVax-L incorporates the full set of tumor antigens, making it difficult for tumors to find ways around it. This is the DCVax product that has been used in NW Bio GBM brain cancer and ovarian cancer clinical trials, and is currently in its Phase III trial. DCVax-L is expected to be used for any solid tumor cancers in situations in which the patient has their tumor surgically removed as part of standard of care. DCVax®-L, is designed to treat solid tumor cancers in which the tumor can be surgically removed. On May 29, 2018, interim blinded data from the Phase III trial collected in March 2017 were published in a peer reviewed scientific journal. On November 17, 2018, updated interim blinded data from the Phase III trial collected in October 2018 were presented at the Society for Neuro-Oncology annual meeting.

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Last month NWBO filed a form D related to the Flaskworks acquisition here. The acquisition of Flaskworks was executed and closed on August 28, 2020. The total purchase price was approximately $4.33 million, of which $1.65 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting, and $0.67 million will be paid in either cash or stock, or a combination thereof, within 120 days after the closing. Flaskworks has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax®.  It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs. Flashworks technical team has joined NW Bio as part of the acquisition.

On October 5 NWBO announced the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked. 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.

The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.

NWBO CEO Linda Powers stated: “We are excited to be so close to the finish line now, after such a long road. We are hopeful that DCVax®-L can become an important new treatment option for patients who urgently need more and better treatments for Glioblastoma brain cancer. We are grateful to the independent service firms and the clinical trial sites who have worked so hard to complete the data collection and confirmation during many months of COVID restrictions and challenges. We are also very grateful to our shareholders for their patience and support, which has made all this possible.”

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) has rocketed past the $1 mark and is currently moving higher after the Company reported the database for the Phase III trial of DCVax®-L for Gliobastoma has been locked and top line data results are imminent. This comes after a long 13 – year wait for investors. Expectations are sky high as Phase III interim data revealed that patients showed a median overall survival (OS) of 40.5 months and were considered “extended survivors”; this population consisted of 30% of the total patients enrolled in the trial. Considering that the median OS for GBM patients is around 15 months, this data is quite astonishing. Patients who experienced tumour recurrence were permitted to cross over to receive DCVax-L. Out of all 331 patients that took part in the study, approximately 90% received treatment with DCVax-L, which included crossover use.  DCVax-L is unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer and represents a potential market expected to reach $1.4 billion by 2025 as the shorts know. Bohsie smartly notes “after all this data and blinded information readily available, a redefined SAP that allows for comparison to contemporaneous trials, and even if the worse-case scenario of the overall survival not meeting the two month increase, there is still enough positive outcomes from this trial that this would readily 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.” Microcapdialy has been covering NWBO since the stock was $0.15 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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