is Retired - a status to which everybody should aspire
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I am amused that in the protocol the DCVax-L is described as an Adjuvant!
No conspiracy theory, just harmless speculation.
Hi Antihama,
The discussion has followed from an announcement on the FDA's website:
On the FDA's website it is stated that the FDA and the MHRA have been considering expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use which will be considered again in July 2025 based on further assessment.
Hank, you are right to be dubious about the FDA adopting or being influenced by any decision made by the MHRA (and any other Regulator) on DCVax-L but I think that there may be reason for hoping that this could be about to change.
There has been a Mutual Recognition Agreement ("MRA") between the MHRA and the FDA since 2021 which has initially only encompassed "Pharmaceutical Good Manufacturing Practices" (GMP) in the field of 1] Vaccines for human use; 2] Plasma derived pharmaceuticals; 3] Investigational products (clinical trial material).
On the FDA's website it is stated that the FDA and the MHRA have been considering expanding the scope of the MRA to include vaccines and plasma-derived pharmaceuticals for human use which will be considered again in July 2025 based on further assessment. This must entail collection of relevant current information so that if the FDA does not actually have a watching brief on the MHRA (and vice versa), it must soon put one into place if it is to have sufficient information on which to decide whether or not to "extend the scope" of the MRA.
It follows that, if not already, the FDA will most probably soon be party to the MHRA's assessments on all the necessary aspects of DCVax-L for its licencing and this can only at the very least shorten the time which it will take the FDA to decide on licencing DCVax-L
Meanwhile, we are continuing to focus on working with our teams of consultants on activities related to the review by the Medicines and Healthcare Products Regulatory Agency (MHRA) of our Marketing Authorization Application (MAA) in the UK, including preparations for inspections by the MHRA that are scheduled to take place in both the US and UK.
No!! A death sentence will be the easy way out for him. A long sentence behind bars without the chance of early release (unless in a box), deprived of his liberty and no longer able to live the life of Riley on his ill-gotten gains is the only just sentence for him and his ilk. This will give him adequate time to help him realise what suffering and deprivation his victims have been placed under thanks to his greed, dishonesty and total self-centeredness.
Everything hinges on Flaskworks. .... Once Flaskworks hits everything else falls into place.
A pointless (and provocative) question at this point of the process. The appropriate time for asking such a question is weeks away.
[clarification] "... which might complement DCVax (and would be less toxic)" .
Sloppy grammatical construction on my part - the "less toxic" refers to DCVax, not the CarT therapy. My apologies.
In "Nature", (12th July) another effective treatment (Car-T) for brain tumours (this time in children) which might complement DCVax (and would be less toxic). The article is at https://www.nature.com/articles/d41586-024-02255-2?utm_source=Live+Audience&utm_campaign=f8586bf0ce-nature-briefing-daily-20240715&utm_medium=email&utm_term=0_b27a691814-f8586bf0ce-51553884.
"It's political"
"British Summer Time" is 5 hours ahead of "Eastern Daylight Time".
Vator 1 : Norisk 0
You are such a pathetic individual with your inane trivialization of the importance of the advances being made by researchers in cancer immunotherapy, all in your venal pursuit of filthy lucre.
Sir Pumpernickel was liberated,
.... and how many times have they been found guilty? I'm sure you know and can tell those of us who don't know.
This has just popped into my email inbox:
Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property
Complementary to Technology & IP Already Owned or In-Licensed; Significant Step in Building a Leading Dendritic Cell Franchise
BETHESDA, MD, June 17, 2024 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.
The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.
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.
As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.
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 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.
The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company's 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company's extensive experience treating compassionate use patients has added valuable ongoing "real world" experience.
"We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies," commented Linda Powers, the Company's CEO. "We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well."
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).
It is incorrect to say that NICE has to evaluate treatments before they can be marketed. NICE's job is to evaluate the efficacy of a treatment to decide whether it should be included in the NHS's list of treatments that can be prescribed and paid for on the NHS.
If the MHRA licences a treatment but NICE decides that the treatment is too expensive for the benefit provided, patients in the UK will still be able to receive the treatment but they will have to cover the financial costs themselves.
He could have been talking about NWBO without mentioning the name. Do you think that the investigations reported in the Wall Street Journal on which he is commenting have been precipitated by NWBO's suit against the Hedge Funds and Market Makers?
His commentary on "Fox Business News" begins with, "So, the Wall Street Journal reports that the US Department of Justice is targeting dozens of prominent short-selling investment and research firms in a sweeping federal investigation that actually began last year. Prosecutors are probing them for illegal trading tactics that include spoofing and scalping. ..... I think it about time that this action has been taken. Listen! the shorts have had a free run of the joint for years targeting many defenseless stocks. Sort of like shooting plastic fish in a barrel in a travelling circus."
Whether it is coincidental with our case or not, it will certainly help us by preparing the ground for NWBO's legal seeds to germinate and flourish.
From my understanding of the situation, if DCVax-L is licenced by the MHRA (and the auguries for this are good) it is highly likely that NICE will rapidly endorse it for use in the NHS as its price will be significantly less than current cancer therapies, something that Mrs Powers has already indicated publicly (and was referred to in a Message on this board within the last week) .
Once DCVax-L is in use in the NHS, there is no legal reason to prevent a competent doctor from adding in poly-ICLC to the DCVax-L treatment even though the poly-ICLC, by itself or in combination, has not been formally tested in a clinical trial for GBM, is not licenced by the MHRA and is not endorsed by NICE. Of course there are provisos for going off-licence: 1] the NHS would not pay for the poly-ICLC (but a 2 week course might be anywhere between $500 - $2,000 [ChatGPT]); 2] the Doctor would have to take full responsibility for what he is doing and would have to satisfy several conditions or run the risk of a penalty, up to and including manslaughter and/or striking off should he be found to have disregarded the guidelines or acted recklessly. This will be adjudged by whether he was acting in line with the following [ChatGPT]:
1] Clinical Justification: The prescriber must have a strong clinical justification for using an unlicensed medication. This typically occurs when no licensed alternative is available or when the licensed alternatives have been ineffective or unsuitable for the patient.
2] Informed Consent: The patient (or their legal guardian) must be fully informed about the unlicensed status of the medication, the reasons for its use, potential risks, and any available alternatives. Informed consent should be obtained and documented.
3] Professional Responsibility: The prescribing clinician assumes full responsibility for the decision to use an unlicensed medication and its outcomes. They must ensure that they are acting in the patient’s best interest and that they have sufficient knowledge about the medication and its effects.
4] Guidance and Recommendations: Organizations such as the General Medical Council (GMC) and the British Medical Association (BMA) provide guidelines on the circumstances and conditions under which unlicensed medications can be prescribed. These guidelines emphasize patient safety, thorough documentation, and clinical necessity .
5] Special Situations: Unlicensed prescribing is more common in certain fields such as pediatrics, oncology, and rare diseases where licensed treatments may not exist or are insufficient.
6] Regulatory Framework: While the MHRA oversees the licensing of medications, it also acknowledges that off-label and unlicensed prescribing can be essential in clinical practice. Therefore, it provides a regulatory framework within which such prescribing is permissible under the aforementioned conditions. [end ChatGPT]
If physicians see from the preliminary studies already done that poly-ICLC significantly boosts the efficacy of DCVax-L with little or no increase in toxicity and that it is within a reasonable price range for their patients (who will not now have to fund the whole of their DCVax-L treatment), it will soon become blindingly apparent that the combination is a highly effective treatment for GBM. The MHRA will then be hard pressed not to give it their (perhaps temporary and conditional) blessing even if they demand that those treated form part of an open trial using the Phase 3 study (as per the NY Academy of Science Journal) as the "historic comparison" group.
This is not a dendrocytic therapy but is immunotherapy using checkpoint inhibitors which the patient developed for the treatment of malignant melanoma. A description of this treatment first appeared as an article last December' in the New York Post. The an article on the BBC's website is an update on the Prof Scolyer's progress whilst he is on his self-designed immunotherapeutic treatment for the glioblastoma which he developed last year.
Australia-based Prof. Scolyer is an expert on the immunotherapy of Malignant Melanoma and is currently involved in the NADINA trial [NeoADdjuvant Ipilimumab Plus Nivolumab Versus Standard Adjuvant Nivolumab] in Macroscopic Stage III Melanoma] with centres in Australia, the USA and Europe. It has nothing to do with brain tumours (unless the melanoma has metastasized to the brain).
The treatment he receive for his GBM brain tumour was based on immunotherapy which he had developed as an effective treatment against Malignant Melanoma. It basically consisted of pre-surgical immunotherapy (aka "neoadjuvant") followed by post-excision immunotherapy with an combination of agents.
As part of the process in the preparation of the vaccine, both the patient's genome and that of the tumour were analysed and this seems to be part of a process to decide what would be the best form of immunotherapy (eg the checkpoint inhibitors anti-PD-1, /PD-L1, /PD-L2, or the monoclonal antibody, anti-CTLA-4 etc.) for treating malignant melanoma.
It is not DCVax-L and is in no way similar to it.
Thanks, Lykiri, for providing the information I was seeking.
Flipper, it is regrettable and I am dismayed that you have taken my perfectly reasonable request for advice as some form of insult. All you had to do was say it was in the amended 10k and, for your information, I am not an asshole (which I presume is a euphemism for "anus"). You have gone down in my estimation.
DocLee
Flipper, I am always impressed by how well informed you are on matters relating to the running and strategies of NWBO's Management. Your latest information, is that the new member of the BOD, Pat Sarma, owns 12,535,165 shares even though that information has not been revealed in the statutorily required instrument.
I presume that the purpose of the compulsory divulging of the shares owned by somebody being appointed to the BOD is to assure shareholders that the new Director has a financial interest in the successful running of the company, an assurance that shareholders need to be given. That this is laid down as being a compulsory action (ignored in this case) can only be because most of us less illustrious shareholders (including me) don't have a clue how to find out that information from publicly available sources. Can you enlighten me as to how to find out that information in the absence of it being provided by the company?
Just so you know, my immediate thoughts as to how you might have found the information on Mr Sarma's shareholding run to:
1] You are part of the Management of NWBO, or,
2] You were given the information by Management to spread around as you think fit. (You are certainly well informed as to what is going on in NWBO), or,
2] You contacted Mr Sarma and asked him directly (If so, how did you know how to contact him?), or,
3] You are Mr Sarma.
We should be told.
But just think how much unpissed you'll be when you are up 100+% (and still climbing).
Nil illegitami carborundum sunt!
(Motto of the foot soldiers in the Roman Legions.)
Newman, you must be correct in your deduction. When the Judge granted the defendants' "Motion to Dismiss" (MTD) and threw out NWBO's case against them, it was not because NWBO's lawyers had failed to present a case that the Defendants had been guilty of illegal activities (in the form of naked shorting). It was because the illegal activities had not been adequately shown to be a cause of the long term depression in NWBO's market value.
However, at the same time as allowing the Defendants' MTD the Judge also gave NWBO's lawyers permission to provide documentation to strengthen their case, specifically, he advised, on the linkage between the Defendants' illegal activities and the long term depression in NWBO's market value. This is a second bite of the cherry for the Plaintiffs, gratis the Presiding Judge. He wouldn't have done that unless he considered that the rest of the evidence was pretty robust.
So, not so worrying a turn of events than as at first glance.
Now you are becoming incoherent and there's no point in continuing any rational discussion.
What a stunning flag 🇬🇧.
GOOD HEAVENS!!! You are not suggesting that some people are actually untruthful in what hey might claim on this Board???
Who could you possibly be referring to??
(Please keep the list of known liars to below 30 so as not to crash the site.)
Your response is interesting in that you completely fail to detect the nuances that an Englishman, Irishman, Scotsman and Welshman living in their native countries would have picked up since most will have spent their formative years in the relatively overpopulated society that is the UK. This breeds localized rivalries between countries, regions, cities, towns & villages and even occasionally between religions. The rivalry is to a large extent carried out through the medium of sport and frequently involves groundlessly insulting the manliness of ones rivals .
Instead all you have done is to big up how much Scotch Whisky is drunk in the United States and its value to the UK economy. Whilst true, all your riposte does is to strengthen the case that you are a money-orientated US citizen posing as an Englishman.
Begone, varlet.
So be a good chap, run along and grab me a Scotch
For sure, it certainly will not !
Do you think that the judge may be getting just a wee bit fed up and irritated by the defendants?
Couldn't happen to a nicer bunch of villains.
Hi, Gary. I'm not sure that what you are suggesting would be applicable for widespread immunisation against acute (as against chronic) viral infections. Bioreactors could grow huge quantities of virus-infected cells exhibiting the viral epitopes against which the dendrocytes are sensitised (although the genetic changes caused by the virus might cause problems with cell viability and replication). To produce a dendrocytic vaccine they would then need to be lysed (no problem there) and then used to sensitise dendrocytes. If (as is now the case with DCVax-L) the resultant sensitised dendrocytes were to be used for 1 person only, the dendrocytes would be from the intended recipient so that their survival would not be a problem after being given back to the recipient.
If, however, the object were to immunise populations against viruses, the current system is not a practical way of doing it as the sensitised dendrocytes would not be from the recipient and so would engender an immunological response by the recipient against these "non-self" dendrocytes. Hopefully the injected dendrocytes would survive long enough to programme significant numbers of the recipient's T-cells to initiate the desired immunological response against the virus-infected cells etc. but in the process they would have programmed the recipients' own "self" dendrocytes against the injected "non-self" dendrocytes. This would mean that after one course of immunisation further injections of "non-self" dendrocytes would face the almost certain risk of instant destruction irrespective of what they were sensitised against - virus or malignancy. In short, immunisation using dendrocytes from somebody other than the intended recipient would be a "one-off" treatment.
For immunisation with an "all-cancer" vaccine (as I originally suggested) this might work as (hopefully) the one immunisation would cover all (or nearly all) known malignant epitopes from existing malignancies and so (hopefully) only one short course of treatment would be needed in a lifetime. However, as we have all recently seen, many viruses (especially respiratory ones) evolve rapidly so that current vaccines are rendered quickly useless and multiple courses of updated versions are needed to maintain immunity. After one course of a dendrocytic vaccine which uses dendrocytes from anybody other than the recipient, theoretically all further courses of any dendrocytic vaccine would be rendered useless unless the subsequent dendrocytic vaccine used dendrocytes from the recipient.
Best wishes.
Hi, Chiugray. Like you and iwasadiver I have little doubt that theoretically the DCvax family could be modified to seek out and eliminate virus infections, but I'm not sure about the practicalities involved. From the quote you give it looks like you and iwasadiver also recognise that its use would be for if a viral infection had become chronically embedded rather than for use in the acute phase of a viraemia. This would entirely relate to the length of time that the process of dendrocyte production in vivo takes meaning that by the time the "therapeutic vaccine" had been produced for the patient's specific viral infection the vast majority of virus infections would have resolved due to the body's immune response. Consequently, one can see that only chronic viral infections which don't respond to simpler treatments would be the scenario for DCVax.
Ex, Apceden looks to be an almost exact copy of the DCVax family in its method of production by a company in India which does not recognise Patent Law when it serves its own purposes, made in a very similar (if not exactly the same) method (ie it is a pirated product) and was approved by the Indian regulator, the Central Drugs Standard Control Organisation (CDSCO). Chat GPT comments thuswise on the Indian Regulator:
The Central Drugs Standard Control Organization (CDSCO) in India, which is responsible for regulating pharmaceuticals and medical devices, has faced allegations of corruption and regulatory lapses in the past. There have been instances where the CDSCO has been criticized for not effectively regulating the pharmaceutical industry, leading to concerns about the safety and efficacy of drugs and medical devices in the Indian market.
Inserted GM-CSF may recruit and activate antigen-presenting cells, which can process and present TDA to promote an effector T-cell response. The exact mechanism of action is unknown and is not meant to imply clinical efficacy.[my emphasis]
I started my discussion with an essentially semantic argument - a discussion about what constitutes "vaccination" as distinct from other forms of medical treatment. I thought this might be of passing interest to others as "Vaccination" is historically a specific form of immunisation; the giving of cowpox virus (variola vaccinae) to an individual to prevent the later development of the infinitely more dangerous human smallpox (variola). This distinction is now irrelevant (but still interesting, I believe) because the term "Vaccination" has now become so hackneyed as to encompass all forms of immunisation as demonstrated by the opening sentence of the article whose web address you provided; viz.
Traditionally, vaccines are designed to stimulate the immune system so that it can prevent disease-causing organisms (pathogens) from establishing an infection.
With the DCVax family we now have the first examples of established disease being treated by vaccination (incorrectly named from my point of view).
ex, I think that you've missed the point that I was trying (perhaps long windedly and clumsily) to make - that potentially the DCVax platform could be developed into one that protects individuals from developing cancer in the first place rather than just treating established malignancies as is currently the case. The 3 treatments that you mention are just that - treatments for established disease, not preventing it in the first place.
Best wishes.
Hi, 3heads. You have the better of me on this one beyond the fact that Mithridatization sounds very similar to desensitisation in allergic conditions. However, I suspect that Mithridaticel might not trip off the tongue as easily as the ad-men would like and that something more snappy would be their choice.
Best wishes.
George, I am not au fait with the case you mention but if he were part of the trial there would be no alteration to the DCVax-L.
If he had been given DCVax-L on "compassionate" grounds (ie after closure of the DCVax-L Phase 3 study) he probably was treated additionally with poly-ICLC and/or pembrolizumab.
If he was not given DCVax-L he might have been part of Dr. Mulholland's trial at University College, London (UCL) which was investigating whether the addition of ipilimumab (an anti-CTLA monoclonal antibody) to the current Standard of Care (SOL) is beneficial.
Best wishes.