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Saturday, December 3, 2022

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Major Breakout Northbound as Dr. Linda Liau Set to Give Presentation on Murcidencel at the Society for Neuro-Oncology Conference on Sunday

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is making a powerful move northbound out of its trading range ($0.60 – $0.80) that it has maintained since the Company released 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 short position launched a major short attack in an effort to make positive results negative and succeeded for a time however things are changing quickly. 

home - societyns.orgThis coming Sunday Dr. Linda Liau will give a presentation as the premier conference for physicians who treat brain tumors at the Society for Neuro-Oncology Conference. As shown in the abstract, the conclusion of her talk is “Clinically meaningful and statistically significant survival extension was seen in both nGBM and rGBM patients treated with murcidencel and SOC compared with contemporaneous, matched external controls who received SOC alone.” NWBO has a very loyal shareholder base who believe murcidencel represents a major breakthrough and that it will become part of standard of care (SOC) in newly diagnosed glioblastoma multiforme (ndGBM); murcidencel also ranks one of the most commercially and medically important drugs ever developed by the biopharma industry. Moreover, the technology used to develop it could be applicable to all solid tumors. 

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a biotechnology company focused on 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. The Company’s lead product, DCVax-L, is currently in a 348-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. The Company’s second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers. The Company has also conducted a Phase I/II trial with DCVax for late stage ovarian cancer together with the University of Pennsylvania. The Company previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer. 

The Company’s lead product, Muricidencel (DCVax®-L,) is designed to treat solid tumor cancers in which the tumor can be surgically removed. We have completed a 331-patient international Phase III trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM). As previously reported, the data collection and confirmation process was conducted by the independent contract research organization (CRO) who managed the trial and by other independent service firms.  On October 5, 2020, the Company announced that Data Lock for the Phase III trial had been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians of 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, in preparation for publication in a scientific journal and public announcement.  This series of processes is under way.  It is anticipated that public announcement will follow these processes. 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.  

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 August 23 NWBO announced it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company’s Pediatric Investigation Plan (PIP).  The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L. The Company’s approved PIP includes 2 clinical trials: one for newly diagnosed pediatric high grade glioma (HGG), and one for recurrent pediatric HGG. In each of the 2 pediatric trials, 24 patients will be treated with DCVax-L on the same treatment schedule as in the Company’s Phase III trial in adult glioblastoma patients.  

The primary endpoint for each of the 2 pediatric trials will be overall survival, determined by comparing the survival of DCVax-L treated patients to matched contemporaneous external controls.  The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients. Under applicable UK law, when a new medicine is developed for adult patients, that medicine must also be tested for potential application to pediatric patients. The sponsor must develop an overall Plan to select the specific form or stage of the disease to be treated, to adapt the dosing and administration of the medicine for pediatric physiology, and to evaluate the safety and efficacy of the medicine in pediatric patients. Further, the Plan must include not just general focus areas, aims and approaches — it must include the full design of the specific clinical trials to be carried out, including all aspects required for clinical trial approvals, such as the patient population, eligibility criteria, stage of disease, treatment regimen, trial design and endpoints.  

The Plan developed by the sponsor must go through a series of stages of regulatory review and comment to reach a final approval by regulators.  This process can typically take more than a year. The final regulatory approval of the PIP must be obtained before a sponsor may submit a Marketing Authorization Application (MAA) for approval to commercialize the new medicine for adult patients.  The approval may include a deferral allowing the pediatric clinical trials to actually be carried out after the MAA has been submitted, but the PIP approval itself must have been received before an MAA can be filed and go through compliance check. 

Northwest Biotherapeutics worked with expert consultants for months to develop a PIP tailored for application of DCVax-L to pediatric cases of HGG. The Company submitted its proposed PIP to the MHRA in February 2022, and has been going through the regulatory review process since then.  On August 17, the Company received final approval of the PIP from the MHRA. The Company’s approved PIP includes a deferral under which the pediatric trials are anticipated to be undertaken after an MAA application has been submitted. 

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)

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Currently trading at a $992 million market valuation NWBO has over $15 million in the treasury and is fully funded moving forward. NWBO just made a powerful move northbound breaking out of its trading range ($0.60 – $0.80) that it has maintained since the Company released results of the Phase 3 clinical trial of DCVax®-L for GBM presented at NYAS on May 10 which prompted the shorts to attack helped along by Adam Feuerstein’s article on Stat News that contained numerous demonstrably false claims that the trial had failed. This coming Sunday Dr. Linda Liau will give a presentation as the premier conference for physicians who treat brain tumors at the Society for Neuro-Oncology Conference. As shown in the abstract, the conclusion of her talk is “Clinically meaningful and statistically significant survival extension was seen in both nGBM and rGBM patients treated with murcidencel and SOC compared with contemporaneous, matched external controls who received SOC alone. 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. 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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