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flipper, did I miss Dr. Ashkan’s reference to a specific submission date? I thought he just confirmed that it had been submitted. By the way, I think the general abstract deadline for SNO was June 1st, and late-breaking deadline was September 1st.
Okay, thanks. Agree that it could be a different journal. . . just sayin.
Thanks ATLnsider, but hasn’t this “secret” list of authors of the abstract been known for a while? I think it would be a very appropriate journal. (and perhaps a way to control the timing?)
Not sure what the average is, but yes, the MHRA attempts to process the application within 90 working days.
Thanks. If it was anyone else who posted that cryptic message, I wouldn’t have believed them. :)
Thanks for the sad news WLWeller. It's comforting to know that she had a full life, but I really wish she could have been around to see Northwest Bio achieve success. Feels like we lost a real supporter, and conscientious investor.
Right, and it’s been over 80 working days since Advent applied for the commercial license.
flipper, I don’t think they needed to have 50 per month capacity, but that is simply the capacity of the initial phase 1A buildout.
The initial phase IA buildout of two suites with multiple isolated high-grade (B) cleanrooms, could first be utilized for Northwest Bio’s compassionate use manufacturing, and then later when Advent completes the build out of Phase 1B as Northwest Bio transitions to the closed, automated commercial manufacturing process in a large, lower-grade (C) suite, Advent can use the higher grade, isolated, clean rooms for their other clients. Sawston is eventually intended as a multi-product facility, and I think with the limited cell therapy manufacturing capacity available, those high-grade manufacturing suites will be utilized.
I’ve said before, that I don’t think the space that Advent subleases (capacity for 50 per month) is sufficient for commercial production, but it will be sufficient for small cell therapy companies that contract with Advent to manufacture for their investigational, clinical programs. Those smaller programs generally begin with manual manufacturing that require that type of suite with isolated, high-grade rooms.
This post is to clarify an earlier post I made here. A friend who reads the board, and watched the ASCO presentation multiple times, was pretty adamant that Shashi Murthy said there was more comparability work to do, (as flipper also noted) so he asked me to clarify how Flaskworks could be part of the commercial license application for Sawston if the comparability study wasn’t completed prior to the application. So I more carefully watched the ASCO presentation for a third time, and agree that Sashi Murthy did say that some comparability work still needed to be done. This however, doesn’t change my thesis that the Flaskworks Eden system is a part of the commercial license application
When I initially watched the ASCO presentation, I was pretty certain that Advent had completed all of the required qualification work (DQ, IQ, OQ, PQ) for the Flaskworks system, and likely most of the validation work for the entire commercial automated process. This would have been a prerequisite for the comparability study, but there wasn’t enough information in that presentation to determine exactly where Advent was in the Flaskworks’ comparability process. (As I’ve posted previously, this type of change protocol likely requires months to prepare and then submit to regulators for their pre-approval, which could take a couple more months)
Qualification is a process of assurance that specific system(s), premises or equipment are able to achieve predetermined acceptance criteria to confirm the attributes what it purports to do. It is the means of providing documented evidence that a specific piece of equipment, facility or system is fit/ready for intended use. In contrast to qualification, validation applies to processes and procedures. Validation is intended to demonstrate in a documented form, that the processes, methods, tests, activities and equipment they deploy are capable of repeatedly producing the desired product. Therefore, each critical step in the manufacturing process must be verified to perform as intended under defined conditions. This validation is required for commercial GMP manufacturing.
When Advent announced the following month that it was filing for the commercial license, and had installed seven new pieces of automated equipment for the manufacturing process, I was confident that Flaskworks was a part of the application, which basically confirmed (to me) that all of the required qualification steps, and automated process validation work according to the Validation Master Plan, had indeed been completed. Although I initially thought the comparability study may have been conducted prior to the submittal of the license application, I don’t believe it’s necessary for the commercial manufacturing license. The Flaskworks Eden system just needed to be qualified and validated, which I believe it was.
The comparability study is required to show regulators that the DCVax “product” is the same after the change(s) in the manufacturing process, as it was prior to the change(s). If the Flaskworks comparability study wasn’t completed before July, Advent could have applied for the commercial license in July, and meanwhile, conduct the comparability study during the summer. Then the CP and analysis could be submitted later (sometime in the past couple of months) so approval of the CP and Flaskworks automated process could be approximately concurrent with the approval of the commercial manufacturing license. Depending on when the marketing application is/was submitted, the CP could be submitted with it, or after it as a post approval supplement.
The mechanics of the Flaskworks’ approval process is actually irrelevant to my overall thesis that the automated process using the Flaskworks system will be used from the get-go when Northwest Bio begins commercialization and negotiates insurance reimbursement. I believe this was always the plan.
And that is why you’re one of my favorite posters! Thanks for all that you do senti. :)
Sojo, have you been gone? Haha just kidding, you and your charts were missed. Wishing you a quick recovery and continued good health!
Thanks for the condolences hoffman and kind words senti. I’ve shared several anecdotes here about my grandfather’s experience with Glioblastoma over the years. They serve as reminders why many of us are here, and how little hope there has been for anyone diagnosed with GBM. Here’s a couple:
In 2016, NVCR charged my grandfather a $20k monthly rental fee for the helmet, and they demanded it back when he died. That was before medicare covered it, and they took his life savings for 10 months of humiliation and burning scalp pain. Now medicare pays about $13k monthly:
Thanks CherryTree. Yes, Linda’s birthday was October 16th. I got her this:
REPUTATION DEFENDER by norton
The most trusted name in online reputation management
https://www.reputationdefender.com
CaptainO, there was approximately 81 million shares available under the limit as of June 30. And yes, the share authorization limit is a real thing, but it’s clearly being managed effectively, and I highly doubt it will be exceeded. Public companies are required to have adequate internal controls to ensure that they don’t exceed the share authorization limit, and there would be consequences for doing so, like fines, penalties, or sanctions by the SEC.
1,034,475 Common Stock outstanding as of June 30, 2022
153,210 Warrants
309,512 Options
__________________
1,497,197
378,600 Warrants and Options suspended (142,000 warrants + 236,600 options)
__________________
1,118,597 Total Common Stock, Warrants, and Options Outstanding
_________________
_________________
1,200,000 Share Authorization Limit
-1,118,597
________________
81,413 Shares Available under the limit
This is Linda’s Powers’ testimony before Congress:
They were known as the GATT Hearings. (General Agreement on Tariffs and Trade) The International Competitiveness Task Force of the House Banking, Finance and Urban Affairs Committee reviewed progress being made on the current General Agreement on Trade and Tariffs negotiations and focused on “foreign dumping:” The concern was that foreign financial firms were selling below cost in the the United States.
https://www.c-span.org/video/?c5017932/user-clip-linda-powers-testifying-congress
Nothing about your supposed Indian Bribery Scandal or misspent millions.
There may be more to this Merck/Moderna “personalized cancer vaccine” news that just so happened to coincidently occur now, right before a potential announcement that Northwest Bio is actually seeking approval and is nearly ready to begin commercialization of a personalized cancer vaccine.
Merck’s collaboration with Moderna to develop mRNA cancer vaccines started back in 2016, and has expanded several times since then. This latest collaboration news isn’t really as big a deal as it’s being made to sound. Perhaps they’re trying to steal some thunder? Hmmmm.
Merck Invests in RNA Startup to Target Cancer
If it works, mRNA therapy could provide a simple way to create customized cancer vaccines.
By Ryan Crossarchive page
July 5, 2016
https://www.technologyreview.com/2016/07/05/158983/merck-invests-in-rna-startup-to-target-cancer/
Moderna and Merck Expand mRNA Cancer Vaccines Collaboration
May 3, 2018
https://www.merck.com/news/moderna-and-merck-expand-mrna-cancer-vaccines-collaboration/
Merck Announces Sale of its Direct Equity Investment in Moderna
December 2, 2020
Merck and Moderna continue to collaborate on the development of personalized cancer vaccines as well as a cancer vaccine that encodes the four most common KRAS mutations.
https://www.merck.com/news/merck-announces-sale-of-its-direct-equity-investment-in-moderna/
Merck opts to develop, sell cancer vaccine with Moderna
Oct 12, 2022
https://www.reuters.com/business/healthcare-pharmaceuticals/merck-opts-jointly-develop-cancer-vaccine-with-moderna-2022-10-12/
Approval, Commercialization Highlighted at Cell & Gene Meeting on the Mesa
At the annual conference in San Diego, gene therapy leaders discussed the challenges of bringing these transformative medicines to market.
By Jonathan D Grinstein, PhD -
October 12, 2022
exwannabe, do we really have to recycle this false narrative again? The fact that you continue to repeat it, leads me to believe that perhaps you may not actually understand cell therapy.
Yes, living cells are complex, so in order to receive regulatory approval, a cell therapy program is required to determine the critical quality attributes (CQAs) of their cells, or the characteristics which define their product (characterization), and to develop analytic testing methods (assays) to analyze each batch for potency, purity, sterility, viability, and stability. This is essential for quality control, GMP product release, and yes for comparability testing of the Flaskworks’ system. UCLA would likely have developed some of the assays to test DCVax for safety and identity in preclinical and phase I trials, and then further characterization and assay development was done by Cognate, Fraunhofer, and more recently by Shashi Murthy. DCVax was fully characterized, and the required assays developed, optimized, qualified, and validated many years ago. As I said to you the last time you perpetrated this false narrative, this is how Linda Liau and other UCLA researchers can say that the ATL-DC vaccine that UCLA is using in the combination trial with Keytruda for rGBM, is basically the same vaccine as DCVax-L.
Sorry for not answering the first time you asked CaptainO, but I thought your question was rhetorical, and the answer was Obvious :) In this rare instance, I think Bob Loblaw is actually correct, and that agreement is confidential.
Some of us have speculated that perhaps it was discussions with the FDA, and the capability to meet SOC demand, back in the summer/fall of 2020 when the SAP was approved and they were nearing data lock, that may have led to the extension pivot, and not revealing top-line data in September 2020, as they originally led everyone to believe. Which is why I believe that Northwest Bio won’t go to market without Flaskworks automated manufacturing. Unfortunately, they’ve been resource starved, and it has taken far too long. But here we are in Q4 2022, and it looks like they finally may be nearing automated manufacturing readiness.
Thanks Lykiri. Maybe the pricing changed when Advent moved to Sawston? This is the pricelist I referenced from last year when Advent manufactured in London:
$NWBO looks like Advent is getting ready to ramp up production at Sawton pic.twitter.com/pqpjVZnVLr
— TiltMyBrain (@TiltMyBrain) April 16, 2021
No flipper, what that Helen Bulbeck quote that Lykiri shared means is that the payment schedule for DCVax is “staged” in several payments over time, not all at once. According to Advent’s current pricelist to manufacture DCVax for “specials” patients in the UK, Advent charges £50k up front for tumor tissue processing, then £100k to manufacture 6 doses for the first year, then £25k for each semi-annual dose for the next two years, which adds up to that £250k.
I think with automated manufacturing, the final commercial negotiated price will be under £200k, and along with this “staged” payment schedule, it will make it more feasible for insurance reimbursement.
Thanks for sharing Lykiri, and additional thanks to Richard K.
no2koolaid, are you aware that DCVax has “orphan drug designation” in the US? It will be exempt from the negotiation process under The Inflation Reduction Act, so this should not be an immediate concern for Northwest Bio or their shareholders.
BP to Linda Powers: (gasping) Uh . . . seriously? You want how much? (chuckling to themselves) I mean for that price, you’d have to have approved process patents, combination patents, patented automated manufacturing . . . and marketing approval.
Linda Powers: Okay
Yes, it’s Merck Merck Merck on this board, but a case could be made for a number of other suitors. How about Bristol Myers? They’ve been out of the picture the past couple of years while they digested Celgene and advanced their pipeline, but they also have a checkpoint inhibitor (Opdivo) that could benefit from a combination with DCVax, and already have cell therapy products, with vast resources for them (including multiple cell therapy manufacturing facilities and a supply chain network). They know that immunotherapy and cell/gene therapy is the future, and have for a long time. And because they have experience with, and are more focused on cell therapies, (and patients) I think they’re probably a better partner for Northwest Bio . . . if it is a partnership. Just spend a few minutes poking around their website:
ski, it doesn’t matter whether the equipment comes into contact with any of the liquids during the manufacturing process, it’s a GMP facility which has highly regulated procedures. Maybe you’re just seeking additional clarification, but I replied to a similar question a month ago:
okay bio, thanks for the clarification.
I agree flipper. Although there are still ongoing supply chain disruptions, and shortages for lab supplies and equipment, companies are adapting. For example, the original MicroDEN system used fill and waste bottles, but the supply for their caps has been disrupted, so some may have noticed that the prototype EDEN device now uses bags instead of those bottles. It’s likely there are other adjustments being made.
I also think that it may be scaled out in a couple of stages to that eventual 1000 capacity, so 250 probably would not be needed initially at the start of commercial production.
Yes senti, the Flaskworks system itself, can and will be cleaned, sterilized, and used repeatedly (after each patient’s treatment has completed in about a week), but the single-use disposables sourced from Saint Gobain, such as the media bags, culture cartridges and tubing which will contain blood products, cannot be sterilized and used again. They are considered biological medical waste and must be properly disposed of according to federal regulations. (most likely autoclaved and ultimately incinerated)
And btw, you are one of my favorite posters here, so happy to help :)
senti, the culture cartridge is the heart of the EDEN system, where a patient’s monocytes are loaded into, and sit for days to differentiate into dendritic cells. It’s the large clear plastic container on the right side of the system shown here:
The reason that I pointed out that there is only one culture cartridge is because biosectinvestor disagreed with me about the number of culture cartridges the commercial system has. The EDEN system in this picture that Lykiri found, is the same device that was pictured in the ASCO presentation, which only had one culture cartridge. That discussion is here:
The significance of the number of cartridges is that one cartridge is used for each patient’s treatment, so the more cartridges a system has, then the more treatments that could be manufactured at the same time. Ideally, an industrial commercial system would be much larger and have multiple culture cartridges so that multiple patient’s treatments could be cultured simultaneously. biosect seems to think that the commercial system has been more fully developed than was pictured at ASCO, into that ideal industrial system.
However, I’m pretty confident that the Flaskworks’ system that has been validated and tested at Sawston over the past year, is in fact, the EDEN system pictured here. I believe that at least a handful were installed for an initial automated production line at Sawston, and this is the automated process that Advent will use to apply for a commercial manufacturing license. Since there’s only one culture cartridge in this EDEN system, it can only culture a single patient’s treatment at a time, so ~250 of these EDEN devices would eventually be needed to meet the capacity of 1000 patients per month at Sawston.
Thanks Lykiri. That’s definitely the EDEN system all right. This only confirms that EDEN IS READY, and IS part of the commercial application at Sawston. That appears to be the prototype model of the EDEN system with all the commercial specifications that will be used for mass production by a contract manufacturer. And yes, it also confirms that there is one culture cartridge per unit.
Well done sir! May I ask how long ago you discovered this?
Why might Northwest Bio want commercial manufacturing ready by a certain time period, and incentivize Advent (through milestone payments) to do so? Why did Mike Scott’s team (Advent) make “an extraordinary effort to meet a 2nd quarter deadline” to submit the MIA application?
By the way, the space that Advent currently subleases at Sawston is not really sufficient to manufacture a product at commercial scale. The only available space available for commercial build out is leased by Northwest Bio.
okay bio, that’s what I thought.
Yes, you’re right antihama, thanks.