Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Just from a momentum perspective, it seems like Commercial Eden is planned/timed to launch just as Sawston is reaching full capacity with manual. IMO.
I have to believe there will be overlap until they can wind down manual whilst further ramping up Eden. IMO.
It’s a stock photo, showing an immunotherapy vaccine dose (of DCVax-l). It raises possibilities, that’s all. It is also interesting the King wants to avoid chemotherapy.
Wrong BNN.
Instead, it was this BNN
It’s in [195] Countries worldwide.
BNN Breaking HQ Address:
Suite 01-02&14, 21/F, Prudential Tower, The Gateway
21 Canton Road, Tsim Sha Tsui, Hong Kong
Sorry for your loss. Be well.
I have no idea what type of cancer King Charles III has, and I have no clue if DCVax-l will play a role in his treatment, but the BNN article on King Charles III with the picture of DCVax-l reminds of another former King of sorts that highlighted the effectiveness of Keytruda for metastatic melanoma.
About a decade ago, former President Jimmy Carter started the melanoma therapy Keytruda less than a year after it was approved. He was the unintended poster (grandpa) child that eventually helped launch Keytruda to the stratosphere.
Best wishes to all cancer patients.
Another subtle but powerful metamorphosis upon (any) approval will be the ability of NWBO to actually promote its therapy instead of restrain or overly restrain themselves from any comment, action, filing or PR that might be construed as marketing.
DMA. Looks like the 50 will touch the 200 and head back up.
Neither Toucan nor Advent own Flaskworks/Eden. The negotiation leverage is with NWBO.
Here is one, and mind you, cost neutral does not mean no profit. Instead it is a technical term that it will not collectively add to U.K. budget when all other factors are taken into account.
Edward Argar
Minister of State (Department of Health and Social Care)
In view of the rapid approval of Project Orbis medicines, NHS England and NHS Improvement and the National Institute for Health and Care Excellence (NICE) have developed an interim process to support patient access to medicines between Project Orbis licensing approval and publication of NICE’s guidance. It is anticipated that this will only be required in the short term. Consideration is given to:
- whether there is expected to be a gap of three months or longer between regulatory approval by the Medicines and Healthcare products Regulatory Agency and publication by NICE of its final draft guidance;
- if there are any direct competitors expected to go through the NICE technology appraisal process within the next six months;
- if the treatment will make a fundamental, positive change to the existing treatment pathway; and
- whether the company will offer the medicine or treatment on a cost neutral basis.
The subtlety that I do think some people miss is that when we do transition to closed system automated technology, that’s our manufacturing, which also means that’s our profit from manufacturing — albeit with assistance from personnel/contractors like Advent and Cognate.
Toucan owns and helped build Advent and subleases the portion of the facility devoted to the artisan method, but it cannot claim any ownership of Flaskworks. Consequently, while we are likely to transition many Advent personnel to Eden, the negotiation leverage will be NWBO’s
I don’t think that’s as important for autologous therapies wherein tissue arrives one at a time. Ultimately, down the road a couple years, perhaps the rate of incoming tissue will justify multiple concurrent process units.
Just finishing up reverse h&s neckline, i’d think Sojo is correct on the major trend going forward.
Oh, I see, you are solely talking about NICE.
Well, there are interim reimbursement routes that utilize alternative pathways, and they can be much quicker, as in concurrent with approval.
In fact, one of the requirements is that NICE reimbursement assessment would take more than a certain number of months.
In my humble opinion, the cancer vaccine working expert group, of whom stonkmaster already posted the list of experts, was not assembled to roadblock cancer vaccines, rather it was assembled to consult and advise.
Cancer vaccines are considered a potential high impact therapy — by the U.K.
The initial maa submission is based upon artisan manufacturing, which is ready, willing and able. Transitioning to automatic closed system automation will be smoother, from a regulatory standpoint, after this therapy is approved, imo.
Thanks Doc. We all miss timing.
I feel very strongly the Artisan beginning is akin to early computing. Needing to do some of the programming ourselves. (Not me) but you know what I mean.
We know too many patients won’t get this therapy early on, but looking for some silver lining, there is a visceral understanding going on when the artisan is allowed to precede the closed system automatic level.
I do believe the combo trials will be the first to treat patients with Eden, or whatever the incoming version is called, because trials don’t require equivalence first.
Cold comfort for many, but let’s celebrate when the rubber hits the road. There are many things that will follow quite rapidly.
You surmise they ran the prototype results — including reasons for version selected— past the MHRA, expert working group and Nice — for advice/input — I’d assume. That is logical.
Hopefully often before and after maa submittal.
Yes, I just didn’t realize the MHRA could conceivably skip seeking advise from CHM.
“ or therapy area experts (specialty expert groups)”
Somehow, I missed the part in bold every time I’ve read this in the past.
The assessment process will run in two phases totalling 150 days with an intervening clock-off period between phase I and phase II, if required. Assessment phase I will be completed within 80 days after clock start. Concerns arising from the initial assessment will be raised with the applicant as a letter requesting further information (RFI).
MHRA will seek advice from CHM and/or therapy area experts (specialty expert groups) during the assessment process, as required.
Also, less worker hours per batch.
DCVAX-L MAA TRACKER
49 days since submission
31 days until Phase 1 is complete* assuming 150 day process.
43 days until the CHM meeting
101 days (if necessary) until Phase 2 is complete (161 with 60 day clock-off RFI (if necessary))*
*Add 1-14 days if assessment clock begins on validation (on or before January 4th)
Ok Doc, I think your prediction that this anticipated announcement is near at hand is becoming more legit, because of the obvious ramifications of having selected the automated version to move forward on.
Linda Powers
Well, that's a big thing. And it can take as much as 30 hours of a qualified person to release a product. So we started more than 3 years ago, okay, not weeks, not months, we started more than 3 years ago with [Advent ] and working on arrangement to develop ways that the product release process could be automated or at least partially automated. So as to not have a bottleneck on this and be ready for scale up.
And (as of December 2022) we're not ready to make an announcement yet, but suffice it to say that's been an area of a big amount of work and a big amount of focus. And we haven't talked about it because we weren't at the stage yet to have something completed. But there's a lot of things that we work on behind the scenes that are forward looking of what do we have to be ready for a year from now, 2 years from now, 3 years from now, because with the time lines involved, if we need something 2 years from now, we have to start today.
And this product release system has been more than 3 years already so far. — December 30, 2022.
I suspect February will provide a few more PRs.
20 years for either type of patent from date of original filing.
Flaskworks, which is NWBO, is getting manufacturing patents. They’ve kept the final version secret until they file the upcoming patent application. It is probably a continuation patent, but it wouldn’t go back further than 2016. It will be written as broadly as possible. Imo.
DCVax-l will be getting biologic protection running from time of approval. IMO. This provides ten years protection from companies attempting to make the same/similar product. Unlike what Ex tries to claim, DCVax-l is not just defined by process, it is also defined by release standards/qualities associated with the final product.
Good thing then that NWBO already took this step:
The next step is to have GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. — NWBO 2/06/24
Great Encapsulation. Should be a sticky. Opinions backed by reason.
You agree but then slimed me.
Anyway, I don’t know why they didn’t bother to announce it.
I could be mistaken, but I believe most people have concluded that since NWBO’s attorney’s confirmed by January 4 of this year that management will be substantially preoccupied with the inspection process for the maa evaluation over three months from that time, AND since management would have had a duty to tell us by now if the maa submission had been rejected and needed to be resubmitted, THEN we can safely assume the maa acceptance was confirmed on or before January 4, 2024.
Clearly management, for whatever reason, did not want to highlight acceptance, but most longs feel confident it has occurred. Imo.
No, they would not. Imo. They just need to start the new trials with the manufacturing closed system automated version that will eventually be approved for commercial use long before those studies complete.
So if that’s true, and the combo trials with several parties begin with automated closed system, can’t we assume most of these could be the types of trials Dr. Pazdur has always wanted?
Seamless phased trials moving and expanding through phase i, ii and iii so long as efficacy and safety is sufficient. Trials that combine approved therapies with established manufacturing methods, so that, by the time any combination is ready for approval evaluation, manufacturing approval will not be necessary.
I’m talking about upcoming combination trials. Those trials would not be stuck with starting with the artisan version, although they would likely need to wait for the gmp commercial grade post-prototype.
Probably the same concurrent length of time it will take for planned combo trials with other parties to be initiated/approved.
Right?
Right. IMO. So let’s go with the thought that all new/upcoming trials will utilize closed system automated manufacturing.
Can we assume they’d not need to conduct equivalence testing prior to starting any new combo trials, because they waited for the correct manufacturing version to be selected before proceeding and can safely assume it will be validated?
In other words, doesn’t it seem like new combination trials can start, if desired, long before DCVax-l closed system automation is approved for commercial use?
I’ve got a couple more questions down this path, but doesn’t this seem correct thus far?
Keeping in mind:
The next step is to have GMP-compliant (i.e., clinical grade) versions of the prototype Flaskworks machine made with GMP grade materials. A specialized contractor has been engaged to do so. This process is expected to take several months, in part due to ongoing supply chain issues. As soon as the GMP-grade units are delivered…. NWBO
New Topic?
What manufacturing method will NWBO use in its (intended) upcoming combination trials?
Artisan or automatic closed system?
I’d assume closed system automatic utilizing the post-prototype device.
Excellent. Thank you Lykiri.
Try harder. That passage doesn’t say what your personal introduction thinks it says.
And, your definition of a biosimilar is wrong. Instead:
https://www.gov.uk/government/consultations/mhra-draft-guidance-on-the-licensing-of-biosimilar-products/consultation-document-mhra-guidance-on-the-licensing-of-biosimilar-products
2.3 Biosimilarity principles
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (the reference product (RP)) in the UK. The guiding principle of a biosimilar development programme is to establish similarity between the biosimilar and the RP based on a comprehensive comparability exercise, ensuring that the previously proven safety and efficacy of the RP also apply to the biosimilar.
A biosimilar should be highly similar to the RP in physicochemical properties, biological activity/potency and clinical profiles. In addition, biosimilar development requires that the impurity profile and the nature of excipients of the biosimilar itself do not give rise to concerns. Any observed differences must be duly justified with regard to their potential impact on safety and efficacy.
The active substance of a biosimilar must be highly similar, in molecular and biological terms, to the active substance of the RP. For example, for an active substance that is a protein, the amino acid sequence is expected to be the same.
The posology and route of administration of the biosimilar must be the same as those of the RP. Deviations from the RP that regard strength, pharmaceutical form, formulation, excipients or presentation require justification and may need additional data.
There is no regulatory requirement to repeat the demonstration of biosimilarity against the RP (for example, in the context of a change in the manufacturing process), once a UK product licence for the biosimilar has been granted.
In order to support pharmacovigilance monitoring, all appropriate measures should be taken to clearly identify any biological medicinal product which is the subject of a suspected adverse reaction report, with due regard to its brand name and batch number.
Flashback:
flipper44
Member Level
Re: post# 427069
Monday, 01/03/2022 3:09:33 PM
Antihama, to answer that question, you might look at the new — May 2021 — MHRA stance on biosimilars, which no longer requires preclinical and/or clinical efficacy studies in most cases. Therefore, if NWBO/Flaskworks is trying to demonstrate biocompatibility with the manual method, logic follows it is a streamlined process.
Whoomp, there it is.
https://www.biopharma-reporter.com/Article/2021/05/14/UK-finalises-biosimilar-guidance-designed-to-improve-on-EMA-starting-point
Lyriki was pointing out that the purported demise of Flaskworks and its team was completely fabricated by DennisDave.
Further Kudos to Lyriki’s recent post.
Calling the whales is a team effort, and this commercial manufacturing automation progress makes it another step easier for NWBO to speak whale. So too would combination trial agreements, an early approval decision in the UK and marketing applications in three additional jurisdictions.
Each step making it progressively easier for additional deep pockets to invest.