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Sunday, November 27, 2022

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) Red Hot as Positive top-line Data in DCVax®-L Phase 3 trial for Glioblastoma is Picked Up by Mainstream Press

Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is rocketing northbound recently surpassing the $1.25 mark on record volume after the Company announced positive top-line results from its phase 3 trial of DCVax®-L for Glioblastoma. Both median survival and the “long tail” of extended survival were increased in both newly diagnosed and recurrent glioblastoma brain cancer patients treated with DCVax®-L. The trial has met both the primary and the secondary endpoint under the Statistical Analysis Plan for the trial and the results were reported in a featured publication co-authored by more than 70 physicians from leading institutions across the U.S., Canada, U.K. and Germany. The Company is now working on preparations for applications for regulatory approval of DCVax®-L. 

The story is quickly getting picked up by mainstream press around the world. According to the article in the Guardian: Vaccine shown to prolong life of patients with aggressive brain cancer; “A senior NHS doctor who was one of the trial’s chief investigators said the evidence showed DCVax had resulted in “astonishing” enhanced survival for patients.” One patient in the 331-person multicentre global study lived for more than eight years after receiving DCVax. In Britain, 53-year-old Nigel French is still alive seven years after having it. Dr Karen Noble, NHS director of research, policy and innovation said: “DCVax represents the first emerging therapy proven effective in treating glioblastoma since temozolomide chemotherapy in 2005 and what the brain tumor community hopes is for it to become affordable, possibly becoming standard of care – so available on the NHS.” 

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Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is a clinical stage biotechnology company focused on the development of personalized cancer vaccines designed to treat a broad range of solid tumor cancers. The Company also owns a valuable intellectual property portfolio; as of December 31, 2021, NWBO had 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products. 

NWBO’s DCVax-L is a fully personalized immune therapy made from a patient’s own immune cells (dendritic cells) and antigens (biomarkers) from a sample of the patient’s own tumor.  A multi-year set of doses is produced in a single manufacturing batch, which takes 8 days.  The product is then stored frozen in individual doses, and is “off the shelf” throughout the treatment regimen.  The doses are stored centrally and simply taken out of the freezer and delivered to the physician when needed for the patient’s next treatment.   

In the Phase III trial of DCVax®-L, median Overall Survival (mOS) for newly diagnosed GBM patients (n=232) was 19.3 months from randomization (22.4 months from surgery) with DCVax-L vs. 16.5 months from randomization in the controls (HR=0.80, p=0.002).  Survival at 48 months from randomization was 15.7% vs. 9.9%, and at 60 months was 13% vs. 5.7%.  For recurrent GBM (n=64), mOS was 13.2 months from relapse vs. 7.8 months (HR = 0.58, p<0.001). Survival at 24 and 30 months post-recurrence was 20.7% vs. 9.6%, and 11.1% vs 5.1%, respectively. In newly diagnosed GBM patients with methylated MGMT, mOS was 30.2 months from randomization (33 months from surgery) with DCVax-L (n=90) vs. 21.3 months in controls (n=199) (HR=0.74, p=0.027). 

From a safety perspective, out of more than 2,100 doses of DCVax-L administered during the Phase III trial, there were only 5 serious adverse events that were deemed at least possibly related to the treatment.  There were 3 cases of intracranial edema, 1 case of nausea and 1 case of lymph node infection.  

Glioblastoma is the most common and most lethal form of primary brain cancer.  Standard of care (SOC) treatments have been virtually unchanged for nearly 20 years.  With SOC treatments, patients typically survive for only about 15-17 months from diagnosis, with the tumor recurring at about 6-8 months from diagnosis and the patients typically surviving for about 7-9 months after recurrence.  Five-year survival from diagnosis is only about 5%. Glioblastoma multiforme (GBM) represents a potential market expected to reach $1.4 billion by 2025. 

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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.  

The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.  

Ms. Powers, CEO of NW Bio, commented:  “We are excited to see the meaningful survival extensions in glioblastoma patients treated with DCVax®-L in this trial – particularly in the “long tail” of the survival curve, where we see more than double the survival rates as with existing standard of care. With well over 400 clinical trials for glioblastoma having failed over the last 15 years, it is gratifying to be able to offer new hope to patients who face this devastating disease. It is especially encouraging to see these survival extensions with a treatment that has such a benign safety profile. Over 2,100 doses of DCVax-L were administered during the trial, and we found that the adverse event profile was not meaningfully different than with standard of care alone.  DCVax-L is also quite simple for the physician and patient:  just an intradermal injection in the upper arm, 6 times over the course of year 1, and then twice a year for maintenance thereafter.” 

Dr. Marnix Bosch, senior author on the publication, concluded “This DCVax-L trial, at 94 hospitals in 4 countries, involved the teamwork of a large number of dedicated investigators.  Publication of the results in the prestigious, peer-reviewed journal JAMA Oncology honors this teamwork and demonstrates how the field can move forward with novel therapies and innovative clinical trial designs.” 

 

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NWBO has just surpassed a $1 billion market valuation as the stock rockets northbound after the Company announced positive top-line results from its phase 3 trial of DCVax®-L for Glioblastoma. NWBO has a lot of room to grow here and should easily be able to take out the $2.05 highs from May now that the Company is being featured by mainstream press. As we said earlier this year: “NWBO 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.”  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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