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ATLnsider, it was just a minor point, so I didn’t really explain it properly. I agree that in some cases, depending on the size of the tumor, enough tissue can be saved to potentially produce 20 or more doses. And Dr. Bosch’s compassionate-use case from that presentation is a perfect example of that. (I had forgotten about that patient, Sarah, so thanks for the reminder of just how impressively DCVax works).
I was just saying that this number of doses is really the exception, and not the rule. So I think assuming stretching payments over 8 to 10 years for everyone, as you posited in one of your pricing assumptions, may be a bit of a reach, but the other possibility of stretching payments over 3 years seems more reasonable to me. And although Sarah had her doses frozen for 7 years, I think the regulators would need a documented stability study to confirm viability for eight or ten years for the commercial product.
Some excellent points ATLnsider, and I’m quite certain that NICE and Northwest Bio will negotiate an acceptable pricing model, (likely spreading payments over years) and DCVax will be covered by the NHS. No doubt about this.
A couple minor points of difference; studies have confirmed product stability for 3 years, or ~10 doses per batch. This will be extended obviously for another 3 years, if a new batch is made for a recurrent patient. Also on your second point, I personally don’t think patients are used for the Flaskworks development work. I thought they could have gone that route years ago, if they requested approval for the Flaskworks process for investigational use, but they didn’t. I think they are probably using a commercially available blood product like Leukopaks, for the comparability studies. Although these products are from healthy volunteers, it’s acceptable to regulators, as long as it’s used for both sides of the comparison.
The ATMP Pricing is really great information, and I hadn’t seen all that in one document. If you notice though, all these ATMP’s are for rare conditions, so the patient number are not large, which is a very big consideration for these countries with national insurance coverage. When you start talking about patient numbers in the tens of thousands per year or more, it could be a real budget breaker. With just the DCVax pricing numbers discussed, in the UK for example, at 3K GBM patients per year, that is close to $750M for that one product alone, and doesn’t even consider the other treatment therapies. (removing Temo will help)
This is why it’s necessary to bring the cost of production down as low as possible, in order to have the lowest price, or the coverage will be limited. I’ve thought that Northwest Bio may bring manufacturing in house (i.e. buy Advent) at some point, to lower the cost of production even further, possibly when automated commercial production begins, or when production numbers reach the point of limiting coverage. This way, the profit that Advent would have charged, could be passed along as cost savings to governments, in order to keep the number of patients covered, as high as possible.
Thanks for sharing this brutal truth smokey. I join everyone here in wishing you the strength to beat this cancer. It’s truly unfortunate that most cancer patients must still endure this poisoning to rid the cancer.
When you see what goes on in the stock market and pharmaceutical industry to put profits over quality of care, and stifle innovation and change, it’s no wonder the standard of care has barely improved in decades. I know we aren’t alone in hoping that Northwest Bio, and next-generation immunotherapies like DCVax, can improve this.
Stay strong, have hope, and never give up!
BS exwannabe. It’s a comparability study, so clinical trials are NOT necessary. You can keep repeating lies, but it doesn’t make them true.
Advent has already proven the Flaskworks systems can produce a comparable product. And guess what? They did it without a clinical trial:
That was one of the more interesting nuggets in the 10-K. I’m certainly not alone in thinking that Dr. Liau and Northwest Bio would like to trial DCVax without the toxic chemotherapy temozolomide (Temodar) handicapping DCVax by damaging and depleting the patient’s immune system, prior to using an immunotherapy, that requires the patient’s own immune system to kill the cancer. Right? This seems like common sense even to us non-oncologists, to support and boost the immune system first, to help optimize and maximize the effect of DCVax and poly-ICLC, and potentially improve the already impressive survival numbers even more.
This case study appears to be a recurrent “Specials” patient, who had another batch made, which may form the basis for excluding chemo in newly diagnosed patients, since DCVax works without Temo in these recurrent cases. And I doubt that it would be difficult to get the patient’s consent for this, particularly once they understand how chemo and immunotherapy work.
If true, this exclusion will be seen as a threat to Merck’s chemo business, but it may be balanced by good news for their immunotherapy business if Keytruda becomes part of the standard treatment option in combination with DCVax and poly-ICLC, in the cases where the cancer eventually returns. I think the incidence of rGBM will probably decline after DCVax becomes part of the front-line treatment though. Either way, as this becomes more clear, it seems likely that Northwest Bio will have Merck’s interest.
Sore subject, but yes ipilimumab (Yervoy) was developed by Medarex, which first partnered with Bristol Myers, and then was acquired by Bristol Myers for a measly $2.4B. In my opinion, it was one of the biggest biotech ripoffs in modern history. (fortunately, Linda Powers wouldn’t let this happen to Northwest Bio)
I owned Medarex, and I was against the buyout. When news of ipilimumab’s ability to shrink tumors came out, the stock price reached $17 a share, but it fell back to about $9, when Bristol offered to buy it for around $16. In the buyout, Bristol Myers acquired Medarex’s UltiMAb Human Antibody Development System, which had 6 or 7 antibodies for immunology and oncology (including eventual blockbusters Opdivo, and Yervoy) in clinical trials, a next-generation antibody-drug conjugate technology, plus royalties on sales of Stelara, Ilaris, and Simponi.
This article paints a picture of a “fruitful” and “transformative” partnership turned acquisition (which I would not) in case you’re interested:
Bristol/Medarex: A Transformational Acquisition Rooted In Collaboration
18 Sep 2017 Joseph Haas
https://invivo.citeline.com/IV005175/BristolMedarex-A-Transformational-Acquisition-Rooted-In-Collaboration
Good article, but not DCVax. First clue was:
100% senti. It’s more than just “a small little biotech company, the small little biotech company that could” (love that line) taking on the titans of Wall Street. There are much larger implications of Northwest Bio’s lawsuit for the market, other companies, and the Department of Justice, to name a few. It could get very interesting . . .
The Financial Times article on Northwest Bio’s lawsuit against the market makers here, apparently generated quite a bit of interest, so the author, Joe Miller discusses the “bombshell lawsuit,” spoofing, and high frequency trading practices on the "Unhedged" podcast.
Inside the traders’ black box
A lawsuit against market makers may reveal how high-frequency trades really work
Ethan Wu speaks to FT legal correspondent Joe Miller
Market watchers have wondered for years about what really goes on inside trading firms like Citadel Securities, Susquehanna and Virtu. A recent ruling in a lawsuit brought by a medical company may provide some answers. Today on the show, host Ethan Wu asks FT reporter Joe Miller about the case, brought by Northwest Biotherapeutics.
https://www.ft.com/content/677b2015-fddf-4538-acf1-d27b18976ec6
Here’s the transcript:
Inside the traders’ black box
https://www.ft.com/content/2ed91dc8-5e13-4dba-a9bb-5004a31e671c
Astavakra, I don’t think the MHRA’s information sharing affects NICE’s assessment decision one way or the other. It merely informs them that the marketing application has been filed so they can begin planning for it, and scheduling assessors and meetings etc., rather than waiting until the applicant contacts them to begin their assessment preparations.
Historically, NICE’s assessment did not begin until after the MHRA market authorization approval decision, so coverage did not begin until many months (6+) later. After Brexit, they attempted to begin the assessment earlier, during the MHRA assessment process, so coverage would occur simultaneously with marketing approval. Unfortunately, their timelines have also been backed up, and this hasn’t really happened. So this guidance is intended to make a meaningful time-saving improvement, which could speed the process, and help to make the coverage available sooner, if not simultaneous.
I think an update (not a decision) from NICE is expected sometime soon, so I doubt it would be considered major news. I personally have no doubt that NICE will cover DCVax, since they have previously covered the CAR-T treatments, which are almost double the price, and had zero long-term data available during their initial assessment. The question I’ve had is: how long will the assessment and price negotiations take? This guidance seems to suggest that the NICE decision may not be that long after marketing approval.
The MHRA shares the marketing applicant’s information with their health system partners now, to speed access to newly authorized treatments:
Right, there's an important distinction between a request for information DURING the first phase of assessment when the assessors are requesting clarification or information from clinical trial sites etc., (as Northwest Bio stated they would in their PR) and a request for information AFTER the initial assessment phase has been completed. If there is still clarification or information needed at that point after the initial assessment, then the assessment clock stops, until the information is provided. This will obviously add time to the length of the total assessment beyond the 150 days, while the information requested during the initial assessment will not.
People are free to believe whatever they want, but I think you are right Smokey. In the latter part of assessment, issues like risk management plans and labeling issues are addressed, and when that occurs, I think management will have a pretty good idea that the application is headed for approval.
The guidance for the 150-day route says that a decision will be reached on approvability within 150 days from submission, (not validation) which is actually a Saturday, May 18th, so on or before Friday May 17th.
The total assessment process is actually 150 days as the title of the guidance, and the guidance itself says; “the assessment process will run in two phases totaling 150 days.”
It really can’t be more clear that there are two phases of assessment; the first phase is 80 days, and the second phase is (implied) 70 days. And, if required, (because the application is missing information or needs clarification) a RFI is sent requesting the necessary information, while the 150-day clock is turned off.
I believe some people may be reading that as though the “if required” part applies to the second phase, but it doesn’t. It applies the the RFI, rather than the second phase. (so the RFI may not be required, but the second phase is required) Again, it’s not called an 80-day assessment, because the second phase is not optional.
CaptainO, you may be referring to a post by Hoffman from a court filing in the derivative complaint against the Officers and BOD, that stated that, but yes it is a fact. Northwest Bio said it themselves when they announced that a marketing application had been submitted to the MHRA:
Excellent! Thanks Lykiri, and Peter.
Right, it should be readily apparent that yesterday’s MHRA announcement doesn’t apply to, or really help Northwest Bio. The first clue is right there at the top, “Details of the process changes for Established Medicines, effective from 1 March 2024, which apply specifically to ‘chemical’ products.” So it would not apply to Advanced Therapy Products.
Secondly, an “established medicine” means one that has already received a marketing authorization and is licensed. Therefore, when a new marketing authorization for an “established medicine” is requested by the license holder, say to treat a new therapeutic indication for example, only a variation to the original marketing authorization is required. Since some assessment criteria has already been previously “established,” and known to the MHRA, the application can be processed more “swiftly.” So once DCVax is approved in Glioblastoma, the approval process to extend the label for other indications, is more rapid.
Although the MHRA is familiar with DCVax, and Northwest Bio has likely previously submitted an Active Substance Master File (ASMF) and Summary of Product Characteristics (SPC) for compassionate use approval, for the purposes of the MAA, DCVax is still considered a new active substance, and will require a full assessment. This is evidenced by the fact that Northwest Bio requested the 150-day route, and not a variation.
It seems to me the MHRA is making a concerted effort to improve their assessment timelines and looked at the easiest areas to improve first, which was with the International Recognition Procedures for medicines that are already approved by other regulators, where only limited assessment by the MHRA is necessary. That was put into effect by the beginning of the year, and now, the MHRA is working on “established medicines” that have already been approved, and also don’t require a full assessment.
As far as the changes about the RFI; what I get from reading that, is that apparently a number of applications are not fully complete, or are lacking some information that is necessary for a complete assessment, and the MHRA does not want to keep making requests for more information if the answers to their RFI are still incomplete. So it seems that in some cases, the applicant, rather than the MHRA, may be partly responsible for extending the MHRA’s timelines, and that change is another way for the MHRA to meet their targets.
I think the fact that Northwest Bio preemptively spent a couple extra months on the front end improving the application, prior to submission, makes it more likely that their application is complete and “high quality,” and therefore will not require the MHRA to issue a RFI. To me that, and the continual progress and concrete steps being taken by the MHRA to improve their timelines, may make it more likely that Northwest Bio’s application will receive an opinion within the established 150-day from submission timeline, rather than 210 days that I previously thought.
LTR, they were all cash. You are right though, that you can avoid the tax gain by holding the new stock if the acquisition is in stock, but stock swaps are rare; it seems almost all buyout deals these days are cash.
ilovetech, too many to remember correctly, but I think three were short-term gains, and one was long-term. I do recall that two occurred near the end of the year, and I hoped that they would not close until the following year to help spread out the tax gains, but of course they all closed the same year.
Smitty, I think it's more likely than not that Northwest Bio is acquired at some point. The range you suggest is on the low end, but even 15B in the near term would probably be considered a serious starting offer by a single company. I doubt it would be a “take it or leave it” type of offer though, and likely not anywhere near high enough if there are multiple bidders.
beartrap, I personally think that a strategic partnership with a company that possesses extensive cell therapy expertise, resources, and infrastructure, that shares the vision of personalized immunotherapy, would be ideal to help develop DCVax to its maximum capability, in the quickest time. This might also be the most lucrative path for investors in the long run, but it does not matter what we want or think is best for the company. It has been my experience that most investors have a shorter-term view. I agree that Northwest Bio is still early in development, but it has taken them so long just to get to this point, that most investors probably thought they’d be much further along in their development by now, when they bought the stock (I certainly did).
If a reasonable buyout offer is made for the company, management and the Board of Directors will meet to discuss and evaluate it, and hire an investment bank to seek the best offer they can, even from other companies; it’s their fiduciary duty. If a reasonable buyout offer is presented to shareholders in the next year or so for a vote, I think the majority would probably accept it, even if it’s lower than most of us want or believe the company is worth. If that’s the case, then the company will be sold, regardless.
As most NWBO investors know, Northwest Bio’s technology platform is disruptive, and I would think that many BioPharma companies would like to own it, while others may view it as a threat. So it seems likely, that if NWBO is in play, there will be more than one company interested in making an offer. If, as you say, a less desirable BP like Roche, with a vested interest in their own competing cancer drugs, (that potentially might slow-walk DCVax development) were to make an offer, it would have to be considered along with any other offer received. I think that the more a company has to pay for Northwest Bio, the less likely they would be to shelve it though. Even with Roche’s resources, it’s one thing to bury a $1B buyout, but it’s quite another for a $25B+ acquisition.
As you also note, DCVax can be combined with many other treatments, and it may actually extend the patents on some of BP’s other drugs. Merck for example, doesn’t have a lot of competing drugs, but it has Keytruda, the best selling cancer drug in the world, that actually complements DCVax, so if a company like that were also to make a competitive offer, that offer would likely be preferable to management and the Board, and it would be the one recommended to shareholders.
I’m not advocating for a quick or low buyout, just relating my experience and opinion. I’ve invested in stocks for over 25 years, and have owned dozens of companies that were acquired, most for much less than I desired or thought they were worth, despite my no vote. One year, 4 companies that I owned were bought out, which I had not planned for, and I got crushed by taxes. It happens. I’m quite certain though that a low-ball offer will not be entertained, and I have confidence in Linda Powers, that if a buyout is recommended by management, it will be for a reasonable price, and to a company that will help DCVax reach its full potential.
Sometimes a partnership deal turns into a buyout, either during the partnership negotiations, or afterward when the acquiring company has a closer look during the partnership. I don’t know the percentages but it happens fairly frequently. I know that I’ve posted one of Mercks buyouts here that happened that way, and that’s what happened with the Gilead buyout of Immunomedics a few years ago that I just posted about:
A record-setting deal
In the beginning of 2019, at a popular industry conference where seeds for future deals are frequently planted, Dickinson met with representatives from a New Jersey biotech called Immunomedics.
Immunomedics had ushered a handful of experimental cancer drugs into clinical trials since its founding in the early ’80s. At the time of its meeting with Gilead, the biotech was waiting to hear whether its most advanced medicine, an engineered antibody for a hard-to-treat form of breast cancer, would receive approval from the Food and Drug Administration.
The two parties talked about Immunomedics’ work, about Gilead’s cancer ambitions, and agreed to keep in touch over the next year and a half.
Gilead wouldn’t be the only company interested in Immunomedics. After the FDA approved Immunomedics’ breast cancer drug — now sold as Trodelvy — that April, the biotech reached out to Gilead and almost a dozen other pharmaceutical firms looking for a partner to help market it. One of those other firms came back with a counter offer: an all-out acquisition.
Dickinson said the offer took Gilead by surprise, especially considering that Immunomedics was just weeks away from presenting more detailed data on Trodelvy. Gilead, having seen the data early because of the partnering talks, knew they were strong and would likely bump up the price on any potential takeover bid.
“We expected it to turn from partnering discussions to an M&A transaction,” he said, “but we didn’t think it was likely that someone would try to do that a week before the company’s key data was going to be publicly disclosed.”
If Gilead wanted Immunomedics, it had to move fast. Two days after the initial acquisition offer, the company proposed its own, much larger bid. After some negotiating, Immunomedics’ board of directors agreed to sell to Gilead for $88 a share, or $21 billion total.
The deal immediately stirred debate. Wall Street analysts acknowledged the high price, which was more than double Immunomedics’ market value from the prior week, was likely to put off some investors, especially since it had become apparent that Gilead overpaid for Kite back in 2017.
Trodelvy wasn’t the neatest fit for Gilead’s strategy, either, since it’s not by definition an immuno-oncology drug. On the other hand, analysts expect Trodelvy to become a billion-dollar drug based solely on its first approval. If it were cleared for use in more cancers, sales could skyrocket.
“This is exactly what we have been waiting for,” wrote the team at Piper Sandler, following the Immunomedics deal announcement.
Trodelvy also provides Gilead, which had mostly worked in blood cancers, a foundation in solid tumors. According to Dickinson, Gilead envisions the drug pairing well with immuno-oncology medicines or targeted therapies, like the so-called PARP inhibitor class of medicines that’s been used to treat prostate, breast and ovarian cancers.
“Sometimes you have to start investing in those smaller pipeline assets, where the science is great and where they match your overall strategy, and then you find the bigger pieces around which to build. Trodelvy is a perfect example,” he said.
https://www.sec.gov/Archives/edgar/data/722830/000110465920108121/tm2030753-2_sc14d9.htm
ski, I’ve admittedly not followed Roche closely, but I’m aware that they are a powerhouse in oncology, and have been the top seller of cancer drugs for years. Their older blockbusters, Rituxan, Herceptin and Avastin, etc., are going to be facing increasing competition from biosimilars just coming onto the market, while the newer Tecentriq, which is approved for lung and bladder cancer, also faces tough competition.
For many years Roche, like most of Big Pharma, has enjoyed the status quo, and has been reluctant to change a business model that has worked quite well for them. But in recognition that change is inevitable, and gene and cell therapy is the future, they’ve recently they made a few smaller early-stage partnership deals in the gene and cell therapy space. They seem to be more interested in allogenic, rather that autologous therapies (like Merck) when they have dipped a toe in the space though.
So right now I think Roche may be interested in Northwest Bio more from the standpoint that they are aware of what’s going on in the industry, and future potential competitive threats, (like everyone else) but I personally don’t see them as a realistic partner, who has any real interest in cell therapy, at this point.
One of the big advantages that Northwest Bio has over other cell therapy manufacturers, is scalable, automated manufacturing, which may disrupt the current personalized-therapy pricing model, and somewhat bridge the gap between the outrageously expensive CART-T and gene therapy pricing model, and the current mass-market biologic cancer treatment pricing. This might entice a company like Roche, who had previously been reluctant to make a significant acquisition in the space, finally make a major move though.
I think what really matters when looking at potential partners, is the type of deal that Linda Powers wants. I don’t know if they still plan to partner out various indications, which seemed to be the plan years ago, licensing, or something more strategic with a company like Gilead or Bristol Myers, who has extensive cell therapy expertise and infrastructure.
Bidding war? Yes, I think that’s certainly possible, maybe even likely . . . Gilead just announced more setbacks, this time for magrolimab in solid tumors. While some cell therapy treatments have shown limited success in blood cancers (lymphomas, myelomas, and leukemia) solid tumors are proving to be far more difficult to overcome. This really demonstrates just how impressive Northwest Bio’s accomplishment in Glioblastoma really is, and why they are likely to be highly sought after.
Did you happen to notice that NWBO’s share price just so happened to move to the same price that certain existing warrants that were expiring and out of the money, but were extended and repriced last year? ($0.55 a share)
What a coincidence huh?
Wake up man! Do you know that Northwest Bio is suing some of the largest Market Makers on WallStreet for manipulation of their stock?
I recently posted the historical growth in (legal) short interest, which has grown from 11 million shares to 55 million shares in the last two years, as Northwest Bio has progressed from data lock of the trial to submission of their marketing application and manufacturing readiness, announcing milestone after milestone. This might be expected if the stock price increased far beyond a reasonable valuation, but that is clearly not the case as it’s still well below $1. There is only one conclusion.
Thanks Lykiri (and pgsd), interesting comments from a couple of highly qualified GMP manufacturing experts, right? Sounds like they are helping Advent and Flaskworks to achieve automated commercial manufacturing readiness.
Drew’s comment, “Great hope for patients with glioblastoma and really exciting news for me and my colleagues as we progress towards marketing authorisation of this ATMP from Advent Bioservices' Cambridge manufacturing site,“ makes me wonder why this group from another company would be so excited for Northwest Bio’s marketing approval, and why he uses the phrase, “as we progress.” Do you suppose that Northwest Bio is paying these consultants with shares of NWBO?
Here’s their qualifications:
Drew Hope is a Senior GMP Compliance Consultant at eXmoor pharma which helps companies to “understand, plan, and implement the appropriate CMC strategy.” Their relevant specialties are: Cell Therapy, Process Engineering, Process Development, Concept Design, GMP Compliance, Bioprocess Engineering, Manufacturing Strategy, Advanced Therapies, and Clinical GMP Manufacture.
Reinout Hesslink is a consultant with over 17 years of experience and an emphasis on CMC, product development and quality control in the field of cell and gene therapies. He has had senior roles at PharmaCell (Lonza) and DCPrime, where he optimized production process development focused on scalability and sustainability. He helped compiling ATMP regulatory filings for both early and late stage clinical trials for companies like DCPrime, Iovance, and Orchard Therapeutics, and managed cell and gene therapy contract manufacturing at BioNTech. As a consultant he has focused on the development of cell and gene therapies and their production process from early clinical up to commercial products.
Anyway, I know why the Flaskworks’ owners might be excited. In case no one else noticed, (besides me and exwannabe) that last PR basically indicated that Flaskworks’ 2nd milestone for the vesting of 25% of their share’s rights from the acquisition, was finally reached. Curious if it occurred in the 4th quarter or the 1st quarter, and if it will be mentioned in the 10K or 10Q. Recall:
You’re right, thanks for the info Lykiri.
Tom, there are several highly specialized cell and gene therapy data management and data analytic software platforms. The two companies that I think you may be asking about, that focus on the “vein to vein” supply chain, are TrakCel and Vineti. Their platforms can operate as stand-alone-systems, or they can be integrated with their customer’s other IT infrastructure. Both have agreements with the cell and gene therapy manufacturers, CDMO’s (and Autolomous who's working with Advent ) as well as the major distributors of cell and gene therapies, and other health care products, (Cryoport, WorldCourier, AmerisourceBergen, and Cardinal, etc.). Trackcel is headquartered in the UK (Wales) and has an agreement with the CGT Catapult since 2017.
DataHow focuses on (big) process data analytics and descriptive process models, and MyCellHub focuses on the production process itself with the generation of real-time audit trails and actively managing workflows and documentation through intelligent work instructions (i.e. MES, digital standard operating procedures, and electronic batch records).
Thanks sojo, nice to see you again, you’ve been missed.
I’ve noticed that you and the other chartists take a lot of flack from the NWBO haters here, and I think it’s because the valuable information that you provide, poses a threat to them and their FUD lies.
Even if you’re not posting, I’m glad to know that you’re sill here, and will be around for the exciting time coming up for NWBO investors.
alphapuppy, they are not just starting to use GMP materials and methods; they always have. However, this is a brand-new bespoke system, which was recently designed and developed on the fly as they worked out the best configurations over the past year with the various GMP components (centrifuge, motors, culture cartridge, sensors, media bottles, perfusion tubes, etc.) which are basically the “guts” of the system.
I’m guessing that once that was worked out, they had to design a new housing unit to put all the components into. The single-use GMP plastic components like culture cartridge, sensors, and tubes, will be sourced from Saint Gobain, which has already been established, while the new housing unit, motors, etc., will be sourced from a new, special contractor that’s familiar with GMP design and materials for clinical use. For example, this means that the materials must not release or leach any substances that could damage the product, it must also be smooth so it could be cleaned easily, with surfaces free from grooves or cracks where bacteria or contaminants could gather, and joints and seams have strict requirements, etcetera. In case you haven’t seen it, this was the first prototype, just to give you an idea of the type of specifications that would be given to the new vendor.
BrightBoy, I can tell that you're excited about the Flaskworks news too - there must have been 20 exclamation points in that post!!!!!!!
I don’t think my post that included various other automated cell therapy manufacturing systems would be considered “advertising,” and if you had read any of the articles, you would know that they are actually applicable to 90% of the various different types of cell therapy, and not only “CAR-T” therapies.
The “point” of posting them was to share information with Chiugray about automated manufacturing systems, because he displayed scientific curiosity about the automated manufacturing process. I thought it would be helpful to show other automated systems that are commercially available to any company developing a cell therapy, because proprietary manufacturing systems, like Flaskworks, are usually kept confidential.
Your comment is noted however, and I will try to keep my posts on topic from now on!
yes ilovetech, there are a number of factors that can determine how much product can be produced, and the number of machines is an important one, particularly if they only perform one function or can produce one treatment at a time. The smaller the footprint, or the more processes a single machine of similar size can perform, then the more machines that you can fit into a cleanroom, so the more product you can produce.
agreed flipper, the current Flaskworks system can probably handle initial demand for the GBM indications, and potentially upcoming clinical trials, so an industrial system isn’t necessary right now. As the label is expanded to other solid tumors though, an industrial process will likely be required to meet a mass market demand.
Hi Chiugray, first, I should say that, as sharpie pointed out, I read the PR wrong about the Flaskworks system being upgraded and its ability to manufacture 10-12 treatments at the same time. I think the system can still only manufacture one patient’s treatment at a time (10-12 doses).
At some point, (maybe in 1-2 years) the system will be industrialized, with the ability to produce multiple patient’s treatments at the same time, as I wrote in that post.
I think you have the right idea, but maybe not exactly. To clarify, only the first two steps are processed by the Flaskworks system; the fill and finish step is still separate. I think this will be accomplished as the patent language states; within one system that has multiple (let’s say 10), individual centrifuges (for cell selection) connected to multiple (10) cell culturing chambers (cartridges) so that each patient’s treatments are separated and processed individually, but run simultaneously in the Flaskworks system by the facility’s manufacturing execution system’s software. Another factor to consider is that the culturing process is normally conducted in an incubator, to control conditions, (98F or 37C and 5% CO2) but I’m unsure how that would be handled.
There are a few other closed, automated cell therapy manufacturing systems out there that I’ve posted about before, the Cell Shuttle from Cellares, and the Cocoon from Lonza.
Recently, CellQuest introduced a new industrialized system that’s capable of producing 10-12 cell therapy treatments at a time. (like I thought Flaskworks could)
This CosyNest system was first introduced a few months ago, and went from startup to commercial readiness in under 3 years, which proves what can be accomplished with proper resourcing and experience. (Flaskworks take note) They call it a mini-factory, and claim it can produce 6,000 CAR-T treatments a year in under a 300 square foot space. Although it’s geared toward CAR-T manufacturing, you might gain some insights from this article about it:
Automated CAR-T Manufacturing Moves toward the Marketplace
By Vivienne Raper, PhD -
January 31, 2024
https://www.genengnews.com/topics/bioprocessing/automated-car-t-manufacturing-moves-toward-the-marketplace/
This article has some good pictures just to give you a visual idea of parallel processing multiple treatments in one system:
Integrating Ancillary Systems – A Bridge to Closed Cell Therapy Manufacturing Processes
https://www.invetechgroup.com/insights/2021/05/integrating-ancillary-systems-cell-therapy-manufacturing/
Thanks senti, I’m surprised the post got the reaction that it did, but maybe it was partly because I totally overestimated the capability of the current Flaskworks system and initial production. :)
Yes Stonk, that's my speculation.
Thanks sharpie, you dream crusher :) Unfortunately, I think you are right about that wording, as I just read that part again. I guess that I assumed that by this time, the next iteration of the system (industrialization) would have been achieved, and perhaps I was a little overzealous when I first read that part, so maybe I read what I wanted to see.
At this point though, I’m ecstatic and grateful to hear that the Flaskworks system can FINALLY produce the equivalent DCVax finished product, and it should be ready for final testing in a few months. The most difficult development work has already been accomplished, and quite honestly, the next iteration upgrade to the industrial system that I discussed, should be relatively quick, and far easier than the development work to date.
Although I may have vastly overstated Flaskworks initial manufacturing capacity, I think you’re right, it’s still A BIG DEAL.