Northwest Biotherapeutics, Inc (OTCMKTS: NWBO) is running northbound after the biotech reported that the Company, along with its partner Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly reported that a MIA license has been approved and issued by the MHRA for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K. This license is the culmination of more than 3 years’ work; now cell therapy products manufactured in the Sawston facility may be exported globally. This represents a major milestone for NW Bio and is an essential step towards submission of its application for regulatory approval of the Company’s lead product, DCVax®-L. This gives NW Bio the green light to move forward with applying for approval of DCVAX by the EMA which is believed the best way for eventual approval in the US.
NWBO is among the topmost traded stocks on the bulletin boards with an enormous following that regularly trades millions and sometimes 10s of millions in dollar volume per day. NW Bio recently reported positive top-line results from its phase 3 trial on DCVax®-L for Glioblastoma, the most aggressive and deadly type of brain cancer representing a potential market already worth $2 billion. DCVax®-L has succeeded where well over 400 clinical trials for glioblastoma have failed with both median survival and the “long tail” of extended survival significantly increased in both newly diagnosed and recurrent glioblastoma brain cancer patients. NW Bio has also commenced a major lawsuit accusing Citadel Securities, Susquehanna and “other Wall Street firms of driving down its stock price through a series of illicit trading tactics such as repeatedly engaging in ‘spoofing,’ where traders place orders with an intent to fool other investors about a stock’s demand and manipulate the price. The lawsuit also includes Canaccord Genuity, G1 Execution Services, GTS Securities, Instinet, Lime Trading and Virtu Americas. We will be updating on NWBO when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.
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Northwest Biotherapeutics Inc (OTCMKTS: NWBO) is a biotechnology company 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. NW Bio has developed a valuable Intellectual Property portfolio that consisted of 204 issued patents and 59 pending patent applications worldwide, grouped into 11 patent families as of January 1, 2022. Of these, 200 issued patents and 47 pending patent applications directly relate to the Company’s DCVax products.
NW Bio’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). This Phase III trial was completed, and the results were presented in scientific meetings and published in JAMA Oncology. NWBO has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue 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. NW Bio 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.
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. DCVax-L is also very 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.
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%. With DCVax®-L, which is successful where over 400 clinical trials for glioblastoma having failed, we see more than double the survival rates as with existing standard of care particularly in the “long tail” of the survival curve. It is especially encouraging to see these survival extensions with a treatment that has such a benign safety profile. The global glioblastoma multiforme treatment market size was valued at USD 2.14 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 8.8% from 2021 to 2028.
It is truly exciting that $NWBO will be able to manufacture #DCVax-L for solid tumor cancer patients around the world, on a compassionate use basis, before the MAAs & BLAs are commercially approved in US, UK, Canada, Germany & rest of the EU: https://t.co/UrEuDY7FuT pic.twitter.com/qMeZK1j82s
— ATLnsider (@ATLnsider) March 21, 2023
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$NWBO Persistence pays. Note; NWBO can now manufacture AND ship WORLDWIDE! https://t.co/Yu4B8U5jaB
— Gregory Zivic, MD (@metacollectiveG) March 20, 2023
Over the past two years NW Bio has been busy building out its Sawston, UK facility, which was designed to proceed in phases, as modules, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. The Sawston facility contains a total of 88,345 square feet on two floors and initial production capacity 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.
With the implementation of the Flaskworks system, NW Bio was able to simplify and streamline many phases of the buildout. The Company acquired Flaskworks, LLC, a company that has developed a system to close and automate the manufacturing of cell therapy products such as DCVax® with Flaskworks becoming a wholly owned subsidiary of NWBO. Flaskworks was previously owned by its technical founders and Corning Inc. The technical team from Flaskworks 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.
On March 20 NWBO announced that the Company along with its manufacturing partner Advent BioServices, a leading contract development and manufacturing organization (CDMO) based in the UK, jointly reported that a MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K.
This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the companies’ knowledge, there are only two other such licenses, one of which was just granted as well. This license is the culmination of more than 3 years’ work, including development of the facility, the teams of specialized personnel, the Standard Operating Procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies in the Sawston facility for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NW Bio.
Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (e.g., immune cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses.
Linda Powers, CEO of NW Bio, commented, “We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax®-L. It is especially exciting to be able to operate globally from this base in the U.K.”
Dr. Mike Scott, President of Advent BioServices, commented, “It is always challenging to be one of the trailblazers. The field of personalised cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape. We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license.”
$NWBO @DanaCasullo @wpri12 @GRDecter @cvpayne
Dear anchors in the US!
Do you know what this means?
An american enterprise has created the first personalized cancer vaccine against brain cancer, DCVax-L and gotten approved their facility in Cambridge in the UK.
–> https://t.co/0VsDiw3xGn pic.twitter.com/uYqPbe5uvf
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) March 21, 2023
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Currently trading at a $622 million market valuation NWBO OS is 1,072,879,079 shares. NW Bio is fully reporting OTCQB and an SEC filer and has stated in the past it will pursue a national listing as biotech progresses forward. NWBO has a storied history on the bulletin boards running from as low as a dime several years ago to highs of $2.50 per share in 2020. In May of this year leading up to May 10 NBWO once again spiked from current levels to over $2 per share. The Company also recently completed its manufacturing facility in Sawston, UK and just reported that a MIA license has been approved and issued by the MHRA for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K. This gives NW Bio the green light to move forward with applying for approval of DCVAX by the EMA which is believed the best way for eventual approval in the US. Many top Doctors believe DC-Vax will seriously disrupt and form the GBM treatment landscape moving forward and save millions of lives. Also, the positive top-line data give Linda Powers and her board ample bargaining power to sell NWBO’s proprietary vaccine to the highest bidder. We will be updating on NWBO when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.
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Disclosure: we hold no position in NWBO either long or short and we have not been compensated for this article.