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Thursday, October 6, 2022

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Major Move Northbound as Sawston Facility is Licensed by (HTA) and (MHRA) & Biotech Awaits Imminent Phase III Top Line Data

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is making a powerful run up the charts ever since reversing off $0.59 lows halfway through December. Volume has been increasing too with NWBO a staple among the top most traded stocks on the otc trading $3 million in dollar volume on a slow day as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that Northwest is on the cusp of major success so many others have failed including many of the biggest names in bio. DCVax®-L is proving itself as an effective treatment/cure for the deadliest, most treatment resistant cancers in the world. 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 continues to be featured regularly in main stream press as many recovered patients have come forward to credit DCVax®-L for saving their lives. NWBO is among the highest risk-reward opportunities in small caps today and if top line data is positive as many think it will be, there is no limit to how high NWBO can go. 

NWBO is also making excellent progress on other fronts recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000 bringing the Company’s cash position to over $20 million. NWBO is pursuing an intensive program of manufacturing preparations and planning recently reporting development of the initial production capacity at its 88,345 square foot Sawston, UK advanced manufacturing facility has been completed. The initial production capacity at the Sawston facility comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor.  These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. The Sawston facility was recently licensed by the UK Human Tissue Authority (HTA) and was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products. 

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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 them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines. Their lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer.  This trial is currently underway at 69 locations throughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late-stage ovarian cancer together with the University of Pennsylvania. Their 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, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida. They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late-stage prostate cancer. NWBO owns a valuable intellectual property portfolio with 199 issued patents and 65 pending patent applications worldwide, grouped into 11 patent families. Northwest has obtained Orphan Drug designation for DCVax-L for glioma brain cancers.  

DCVax® is a platform technology that uses activated dendritic cells (the master cells of the immune system), and 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. 

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. We believe the broad applicability of DCVax to many cancers provides multiple opportunities for commercialization and partnering. DCVax has an excellent safety profile and is on-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 – no “serious adverse events” – related to the treatment. 

Northwest has been very successful raising money recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000 bringing the Company’s cash position to over $20 million. The Loan has a maturity of 22 months and no payments are due for the first 8 months of the Loan term. Upon announcement of the top line data from the Company’s Phase III clinical trial of DCVax®-L for glioblastoma brain cancer, the Lender has a then-springing right to exchange the outstanding balance of the loan for common shares priced at the price of the first private placement transaction following TLD less a 12% discount and to purchase another 50% of that number of shares at the same price. This then-springing right expires 14 days after the post-TLD private placement. 

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.”   

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NWBO

DCVAX Survival Stories & Testimonials
Alice – Metastic Merkel Cell patient from Florida – ASCO 2018
Brad Silver – GBM patient from Huntington Beach, California – ASCO 2018
Sarah Rigby – GBM patient from Hong Kong – ASCO 2018
Kristyn Power – daughter of GBM patient from Canada – ASCO 2018
Kat Charles – GBM patients from UK – ASCO 2018 – as related by her husband Jason (Kat’s Cure)
Prospective patients may contact NW Bio at patients@nwbio.com
UCLA Jamil Newirth DCVax-Patient Video – 2015
Allan Butler Video – National Geographic Vice President – DCVax-Direct patient from Phase 1 Trial with Pancreatic Cancer
NWBO – Patients Sunday Dennis and Jami Newirth – Enrolled at UCLA – Vimeo, Uploaded approx. May 2015
NWBO – Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) – NBC Channel 4, Southern California, February 24, 2015
NWBO – National Geographic’s Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
NWBO GBM Brain Cancer Suvivial Story of Brad Silver
NWBO, GBM Brain Cancer Survival Story of Mike Gregoire
UCLA – Real Stories Using DCVax

NWBO is pursuing an intensive program of manufacturing preparations and planning as the Company awaits top line data from its Phase III trial of DCVax®-L. Northwest recently announced development of the initial production capacity at its 88,345 square foot Sawston, UK advanced manufacturing facility has been completed. To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The initial production capacity at the Sawston facility comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor.  These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. 

The Company has made significant headway recently getting licensed by the UK Human Tissue Authority (HTA) giving the Company the right to work with human tissues for medical products. More recently the Company was approved 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. 

The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme. 

Microcapdaily first reported on NWBO on November 18, 2018 when the stock was $0.20 per share stating the time: “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. The company operates in the booming global cancer biologics market which is expected to reach USD $87.6 billion by 2024 and is projected to grow substantially over the forecast period from 2017 to 2024. Increasing prevalence of cancer and patent expiry of related drugs is anticipated to boost the oncology biologics market. 

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NWBO is making a powerful run up the charts ever since reversing off $0.59 lows halfway through December. Volume has been increasing too with NWBO a staple among the top most traded stocks on the otc trading $3 million in dollar volume on a slow day as Investors eagerly await top line data from the Phase III trial of DCVax®-L. Speculation is sky high that Northwest is on the cusp of major success so many others have failed including many of the biggest names in bio. DCVax®-L is proving itself as an effective treatment/cure for the deadliest, most treatment resistant cancers in the world. 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 continues to be featured regularly in main stream press as many recovered patients have come forward to credit DCVax®-L for saving their lives. NWBO is among the highest risk-reward opportunities in small caps today and if top line data is positive as many think 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. NWBO is also making excellent progress on other fronts recently closing a financing agreement with Streeterville Capital, LLC for net proceeds of $15,000,000 bringing the Company’s cash position to over $20 million. NWBO is pursuing an intensive program of manufacturing preparations and planning recently reporting development of the initial production capacity at its 88,345 square foot Sawston, UK advanced manufacturing facility has been completed. The initial production capacity at the Sawston facility comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor.  These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually. The Sawston facility was recently licensed by the UK Human Tissue Authority (HTA) and was approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products. 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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