NorthWest Biotherapeutics Inc (NWBO)

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dstock07734

Re: beartrap12 post# 708244

Thursday, July 25, 2024 2:11:02 PM

beartrap,

You are right. The future is enormously bright.

I think I got it wrong about the DOD grant. The following trial is supported by DOD.

Dendritic Cell Vaccines Against Her2/?Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
https://clinicaltrials.gov/study/NCT04348747

Novel Immunotherapy for Brain-Metastatic Breast Cancer
https://cdmrp.health.mil/search.aspx?LOG_NO=BC180510



Re: None

Thursday, July 25, 2024 9:19:47 AM

Post#
708126
of 708256
Excellent post by beartrap12:

dstock, this ph 2 trial you found appears to be the third Ph 2 we in-licensed from Roswell and uses their DCs, NOT our DCVax-L. Note the use of intra-tumoral administration mentioned in the NWBO PR on Roswell and also in the cllinical trial that starts 10/1/2024. DCVax-L is not administered intra-tumorally:

Here is what we now own, according to our PR:

The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.

From the clinical trial:

Patients may also receive an autologous dendritic cells intratumorally on day 50.

Great find, dstock! Thank you for all your hard work.

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8:21 AM · Jul 25, 2024
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ViewsPeter Davis
@peter_brit
With $nwbo stating at the ASM that they are "working on collaborations but are not yet ready to announce these yet" and with Linda Power's master class in acquisition and in-licencing deals to date, I am really looking forward to these announcements. Should we really be surprised ? Linda's curriculum vitae is nothing short of outstanding and when she stated "Go Big or Go Home" I for one, would not bet against her achieving this with $nwbo and DCVax® - 'the gift that keeps on giving'

Ms Linda Powers | Chief Executive Officer
Northwest Biotherapeutics Inc



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Peter Davis
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#dcvax $nwbo #gbm

Excellent post by Foogie88:

THERE ENTIRE POST
Flaskworks “EDEN” _ “ISSUE FEE PAYMENT RECEIVED” – JULY 23, 2024

The Flaskworks’ news is a VERY BIG DEAL, so don’t let the muted stock reaction fool you. The stock price is being suppressed by entities that are against Northwest Bio in order to create uncertainty and doubt about any positive news, with the idea being, that the news can’t be that important if the share price hardly increased. Nothing could be further from the truth.
In a nutshell, this Flaskworks news means that when Northwest Bio receives marketing approval, they will soon after, be able to produce their DCVax product to meet very strict commercial quality standards, in large quantities, at a low cost, and they will have patent protection from all the other competition that will come along and attempt to copycat Northwest Bio’s cell therapy. The biggest takeaway is that Northwest Bio has now industrialized the production process of a cell therapy, and they will be capable of producing tens of thousands of treatments annually, and eventually ramp up to hundreds of thousands as other solid-tumor indications are approved, and demand increases.
Due to the lack of any updates about the Flaskworks’ system for over a year, the haters have recently suggested that Flaskworks’ development has stalled, and that Northwest Bio is still years away from regulatory approval for an automated manufacturing system. They say that if and when Northwest Bio does receive marketing approval from regulators this year, they will have to produce the product using the very expensive, inferior manual process, which means they will only be able to produce hundreds of treatments annually, and they may not get insurance reimbursement because it will be too expensive to produce, or they won’t be able to earn much of a profit even if they do. This PR put all those ridiculous lies to death.
Since the Flaskworks acquisition in 2020, Northwest Bio (actually Flaskworks and Advent) has in fact, been very busy developing the original Flaskworks MicroDEN system, which was designed as a bench-top device intended for clinical trial production, which has lower regulatory requirements, and turning it into a commercial system with biosensors that are capable of providing real-time feedback on culturing conditions, and the ability to adjust those conditions as needed. This is necessary for commercial production, which has much higher regulatory requirements. The prototype culturing system was first revealed during a presentation entitled, Manufacturing of DCVax-L Past, Present and Future by Dr. Marnix Bosch, Chief Technical Officer of NW Bio, at ASCO on June 4, 2022. (better pictures here )
Yesterday’s Flaskworks press release revealed that in the time period since that ASCO presentation, Northwest Bio (Flaskworks and Advent) have actually further developed that commercial system, which was capable of producing one patient’s treatment (10-12 doses) at a time, into an industrial commercial system that is capable of producing 10-12 patient’s treatments (100-120 doses) at a time. This is A VERY BIG DEAL. With this Flaskworks automated process, Northwest Bio will be able to produce tens of thousands of treatments a year. All of the current companies with CAR-T cell therapy treatments are capable of producing a single patient’s treatment at a time, and are only able to produce a few thousand treatments a year. They are currently unable to meet patient demand, with long backlogs, and rationing care, which obviously limits the revenue they can earn.
So this Flaskworks news means that when the Flaskworks automated production process is approved, Northwest Bio will have the only commercial cell therapy treatment in the world that can produce enough treatments to meet a very high patient demand, which means this company will become much more valuable because the potential available revenue just skyrocketed. What this also means is that ten times the number of treatments can be manufactured from the same cleanroom footprint of that first iteration. As I said in another post a couple years ago, I think this may be what Michael Bigger was referring to as “cleanroom disruption.”
This brings up another interesting feature that was discussed in the press release; that the updated system now incorporates another previously separate process, in addition to cell culturing. As I’ve said in other posts, the manufacturing process has three main stages; the separation of the monocytes from the other white blood cells in the leukapheresis material, the culturing of those cells, and then filling the final product into individual dosage vials and cryopreserving. This new system now combines the first two steps in one system so that it not only requires less manufacturing systems, but it also allows those steps to be enclosed in one system so that it’s not necessary to transfer the cells from one machine to another, which saves time, reduces potential contamination, saves critical cleanroom space, and cuts down on expensive manpower.
Some have have speculated or at least hoped that the automated Flaskworks production process is a part of the marketing application, and it will also be approved when the DCVax product is approved. Linda Powers threw cold water on this idea at the shareholder meeting a year ago, but because the marketing application took so long to finish, some still thought that in that extra time, the development work on the Flaskworks system might also be finished. This PR dispelled this speculation, because it said that final installation, validation, and testing of the system will still need to be accomplished before it can be approved by the regulators, and the marketing application has already been submitted.
So the question that many may be asking is: “How long until it is approved by the regulators?”
First, I think it’s important to note that some of the development work that has already been completed was, “producing finished DCVax-L products with substantially the same composition and percentage purity of dendritic cells, the same biologic profile and functional characteristics of the cells, and the same yield in number of doses as with the existing manual process.” So Advent has already demonstrated to their own satisfaction that the Flaskworks’ system can produce an equivalent product as the current approved method. Now they just have to demonstrate it to the satisfaction of the regulators. They have also already engaged a contract manufacturer to make the systems that will be installed and validated at Sawston which may take a few months to receive. Then the validation - the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), will take a few months. Then, a few side-by-side runs for the comparability study, and gather and assess the data, and submit the Comparability Protocol to the MHRA which could take a couple more months. The MHRA should be able to review the CP within a couple months, but possibly longer if there are still staffing issues. (the EMA has a 60-day response time for this type of filing, but I’m unsure about the MHRA) If all goes well, it may be possible to receive regulatory approval, and begin automated commercial production with Flaskworks by the end of the year.
So, in summation, ………… THIS IS A VERY BIG DEAL! MFG,……MFG………MANUFACTURING…………..!!!!!!!!!!!!!

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8:35 AM · Jul 25, 2024
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Ms. Linda F. Powers is the Chairman and Chief Executive Officer of Northwest Biotherapeutics (NW Bio), a publicly traded, NASDAQ listed Company developing personalized immune therapies for cancer. Ms. Powers has served as Chairman since May 2007, and as CEO June 2011.

Previously, Ms. Powers served as a Managing Director of Toucan Capital Fund II, a venture capital fund focused on immune therapy and regenerative medicine companies, commencing in 2001. She also has over 15 years’ experience in corporate finance and restructurings, mergers and acquisitions joint ventures and intellectual property licensing.

Ms. Powers is a Board member of M2GEN (an affiliate of Moffitt Cancer Center), the Chinese Biopharmaceutical Association, and the Rosalind Franklin Society. She serves on the MD Stem Cell Research Commission, and was the Commission Chair for the first two years of the state’s stem cell funding program. Ms. Powers served for more than 6 years on the Board of the Trudeau Institute (a specialized research institute focused on immunology). Ms. Powers served for several years on a Steering Committee of the National Academy of Sciences, evaluating government research funding, and has been appointed to three Governors’ commissions created to determine how to build the respective states’ biotech and other high-tech industries. Ms. Powers serves on the boards of a number of private biotechnology companies.

For six years, Ms. Powers taught an annual internal course at the U.S. National Institutes of Health, for bench scientists and technology transfer personnel, on the development and commercialization of house medical products. She also taught for eight years as an adjunct professor at Georgetown Law School.

Ms. Powers holds a B.A. from Princeton University, where she graduated magna cum laude and Phi Beta Kappa. She also earned a J.D., magna cum laude, from Harvard Law School.

https://terrapinn.com/conference/emerging-disease-vaccines/speaker-linda-POWERS.stm

Flaskworks acquisition:-

Northwest Biotherapeutics Acquires Flaskworks: Breakthrough Automation Technology For Cell Therapy Products To Enable Scale-Up of Production Volumes and Reduction of Production Costs

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.

The acquisition includes both intellectual property owned by Flaskworks and a license of additional intellectual property from Northeastern University.

https://nwbio.com/northwest-biotherapeutics-acquires-flaskworks-breakthrough-automation-technology-for-cell-therapy-products-to-enable-scale-up-of-production-volumes-and-reduction-of-production-costs/

Roswell Park in-licensing:-

"The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski"

"The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking)"

"The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies"

https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property/

Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property

https://roswellpark.org/sites/default/files/2022-12/51330-innovation-tech-quick-facts_vf4.pdf

https://x.com/hoffmann6383/status/1807137334934278619
Last edited
7:23 AM · Jul 25, 2024