Replies to post #611505 on NorthWest Biotherapeutics Inc (NWBO)

[NotSure2]

Hyperopia is 100% right. (follow the money).

-> As for rolling review or not?
The fact the it takes aprox 60 days per modules during a rolling review, but it took ~ 25 days per modules for NWBO tells me that they are not in a rolling review. (and asm text overall).

I think that they are aiming for the 180 days (clock stop excluded) option that will be process through multiple countries once submitted. In total this option take aprox 14-16 months after CHM meeting.

For NWBO I believe it will take longer (not because management bad blah blah blah but because it is a novel drug).

MAA aproval for UK early 2025. We almost there.

[Bright Boy]

Dear Hyperopia

I beg to differ on all your points, most importantly,"CHM endorsing the formation of an expert working group on cancer vaccines during their March meeting . . . was being formed specifically to advise on how to handle NWBO's application.” Nor do I think “that 'cancer vaccines' means DC-Vax.”

That is exactly the reason the expert group was formed and cancer vaccines does mean DCVax-L.

Cheers,

BB

[sentiment_stocks]

I wondered if they were not referring to the RNA vaccines they’ve been so excited about as well.

Still… it got me wondering as to what they meant by developing an

end-to-end regulatory pathway for personalised immunotherapy particularly cancer vaccines

Does this sound a bit like a new pathway is being formed?

[pgsd]

.......as my links show this does not exclude DCVax from the UK's future plans as follows:-

Amanda Pritchard, chief executive of the NHS said:

The NHS will not stop in its efforts to pioneer new treatments that could be life-changing for future generations. This is why we are developing our very first Cancer Vaccine Launch Pad, enabling us to identify thousands of NHS patients suitable for cancer vaccine trials – giving them the earliest possible access to cutting-edge technology that has the potential to change cancer care forever.

https://www.gov.uk/government/news/major-agreement-to-deliver-new-cancer-vaccine-trials

"BioNTech is the first partner for the Cancer Vaccine Launch Pad, but the platform is being designed to accommodate additional companies in parallel"

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172378789

[ae kusterer]

Hyperopia: is myocarditis a concern for mRNA patients ?



Re: hyperopia post# 611505

Wednesday, July 19, 2023 1:09:52 PM

Post#
611611
of 611878
.......as my links show this does not exclude DCVax from the UK's future plans as follows:-

Amanda Pritchard, chief executive of the NHS said:

The NHS will not stop in its efforts to pioneer new treatments that could be life-changing for future generations. This is why we are developing our very first Cancer Vaccine Launch Pad, enabling us to identify thousands of NHS patients suitable for cancer vaccine trials – giving them the earliest possible access to cutting-edge technology that has the potential to change cancer care forever.

https://www.gov.uk/government/news/major-agreement-to-deliver-new-cancer-vaccine-trials

"BioNTech is the first partner for the Cancer Vaccine Launch Pad, but the platform is being designed to accommodate additional companies in parallel"

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172378789
Bullish
BULLISH


Re: tunnelvisionofplenty post# 611348

Wednesday, July 19, 2023 10:25:49 AM

Post#
611505
of 611874
tunnelvision, since you asked, here’s my take: I do agree that it appears that the UK government is attempting to bring innovative medicines to market faster, which is good news for Northwest Bio. But I don’t think that “the CHM endorsing the formation of an expert working group on cancer vaccines during their March meeting . . . was being formed specifically to advise on how to handle NWBO's application.” Nor do I think “that 'cancer vaccines' means DC-Vax.”

It seems that you may have missed the big hoopla being made recently by the mRNA companies foray into cancer vaccines after their success with Covid vaccines. And the MHRA seems to have bought it.

UK plan for national mRNA cancer vaccine advance
Published 6 January
By Michelle Roberts Digital health editor

The UK is embarking on an ambitious plan to accelerate research into mRNA cancer vaccines, with German pharmaceutical company BioNTech.

Following the success of Covid vaccines using the same messenger-ribonucleic-acid technology, scientists now want to conduct more trials in cancer patients.

And they are hoping to provide this personalised type of treatment to about 10,000 patients by 2030.
Britain is the first nation to sign up to such a partnership.

BioNTech has several international cancer vaccine trials in progress but says the UK is ideally placed as it has a great track record and infrastructure for medical research.

Some of the patients in the trials will have cancer that has already been treated and the vaccine will hopefully prevent it returning.

Others will have advanced, spreading cancers the vaccine might help shrink and control.

Unlike chemotherapy, which attacks lots of different cells as well as the cancer, the mRNA treatment is tailor-made for the individual and presents the immune system with bits of genetic code from the specific cancer so it can attack only the tumour.

This makes it more expensive to produce. BioNTech says it will be affordable for healthcare systems. But much more work is needed to determine whether the cost can be justified for the NHS. Being commercially sensitive, the details of the partnership between the Government and BioNTech have not been disclosed.

'Wanted poster'
BioNTech co-founder Prof Ozlem Tureci told BBC News: "The UK is a great partner for this endeavour.

"We have seen in the Covid-19 pandemic with the fast approval of vaccines in the UK that the regulatory authority is exceptional.
"And then there is the genomic-analysis capabilities. The UK is one of the leading nations in that regard.

"The concept here is to use specific molecular features in individual cancers of patients to encode them into the mRNA vaccines and to train the immune system to attack."

It was like putting up a bounty or wanted poster, she said, alerting the body to be on the lookout and fight.

And because cancer is a complex disease, patients might need several doses to keep the immune system on guard.

Health and Social Care Secretary, Steve Barclay said: "Once cancer is detected, we need to ensure the best possible treatments are available as soon as possible, including for breast, lung and pancreatic cancer.

"BioNTech helped lead the world on a Covid-19 vaccine and they share our commitment to scientific advancement.
"This partnership will mean that, from as early as September, our patients will be among the first to participate in trials and tests to provide targeted, personalised and precision treatments using transformative new therapies to both treat the existing cancer and help stop it returning."

Cancer Research UK welcomed the news, but said delays in diagnosis and treatment mean staff are increasingly overstretched and may be unable to find the time needed to set up clinical trials - if this continued it would mean slower progress towards new treatments.

CRUK spokesman Dr Iain Foulkes said: "mRNA vaccines are one of the most exciting research developments to come out of the pandemic, and there are strong hints that they could become powerful treatment options for cancer.

"Getting there will require lots more research."

https://www.bbc.com/news/health-64176038


New partnership to boost research into vaccines for cancer
New cancer trials to begin using personalised treatment to save lives.
From:
Department of Health and Social Care and The Rt Hon Steve Barclay MP
Published
6 January 2023

* Secretary of State for Health and Social Care Steve Barclay to sign memorandum of understanding with BioNTech SE today to bring innovative vaccine research to England with the potential to transform outcomes for cancer patients

* The collaboration will aim to deliver 10,000 personalised therapies to UK patients by 2030 through a new research and development hub creating jobs and strengthening the UK’s position as a leader in global life sciences

* The new partnership will help accelerate clinical trials of personalised immunotherapies for cancer and infectious disease vaccines

Trials into vaccines for cancer and wider diseases will accelerate after the government reached a historic agreement with a leading biopharmaceutical firm to bring revolutionary research to England.

A memorandum of understanding will be signed today by Secretary of State for Health and Social Care Steve Barclay and the Germany-based company BioNTech, which previously developed a world-leading COVID-19 vaccine with Pfizer.

The agreement means cancer patients will get early access to trials exploring personalised mRNA therapies, like cancer vaccines. No 2 cancers are the same and mRNA vaccines will contain a genetic blueprint to stimulate the immune system to attack cancer cells.

Access to the trials will be through the Cancer Vaccine Launch Pad, which is being developed by NHS England and Genomics England.

The launch pad will help to rapidly identify large numbers of cancer patients who could be eligible for the trials and explore potential vaccines across multiple types of cancer. Trials for innovative treatments could start as early as autumn 2023. . . .

https://www.gov.uk/government/news/new-partnership-to-boost-research-into-vaccines-for-cancer


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Clinical Considerations: Myocarditis after COVID-19 ...

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Nature Journal
https://www.nature.com › ... › comment
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Myocarditis after mRNA COVID vaccine risk real, but rare in ...

University of Minnesota Twin Cities
https://www.cidrap.umn.edu › covid-19 › myocarditis...
Nov 21, 2022 — A new large Canadian study shows a small but significant increased risk in myocarditis among young men who get mRNA COVID-19 vaccines, ...

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https://www.nejm.org › doi › full › NEJMc2109975
mrna myocarditis from www.nejm.org
by AK Verma · 2021 · Cited by 200 — Myocarditis after Covid-19 Vaccination Two patients who had received Covid-19 mRNA vaccination are described. One received the BNT162b2 ...

COVID-19 subcommittee of the WHO Global Advisory ...

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John Wiley
https://onlinelibrary.wiley.com › doi › clc
mrna myocarditis from onlinelibrary.wiley.com
Author Year Country Cases Age(s) Male (%) Vaccines Dosea
Bautista et al. 2020 Spain 1 39 100 1 BNT162b2 2nd
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Mansour et al. 2021 USA 2 21–25 50 2 mRNA-1273 2nd
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Update on Myocarditis following m

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https://www.fda.gov › media › download
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https://www.acc.org › circulating-spike-protein
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Jan 9, 2023 — Myocarditis and pericarditis after COVID-19 vaccination: clinical ... with a mRNA vaccine (Pfizer/BioNTech or Moderna); myocarditis and ...

Circulating spike protein found in patients with mRNA ...

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Jan 10, 2023 — Incidence of myocarditis or pericarditis after mRNA vaccination was reported to occur at a rate of one to two cases per 100,000 vaccinated, ...

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by Z Naveed · 2022 · Cited by 16 — We sought to estimate the incidence of myocarditis after mRNA ... per 100 000 mRNA vaccine doses, expected rates of myocarditis cases and ...

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Jan 10, 2023 — Myocarditis is estimated to occur in 18 out of every 1 million vaccine doses administered, typically in adolescent and young adult men within ...

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Studies link myocarditis cases to mRNA vaccines

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Jun 30, 2021 — Two new studies out of the US have tracked cases of myocarditis that developed within days of people having either the Pfizer or Moderna mRNA ...

Benefits of COVID-19 Vaccination Outweigh the Rare Risk ...

FactCheck.org
https://www.factcheck.org › 2022/03 › scicheck-benef...
Claim: “We now have the scientific evidence that shows the risk of myocarditis for young males is greater for the vaccine than it is for the disease.”
Claimed by: Rand Paul
Fact check by FactCheck.org: Vaccine Benefits Outweigh Risk
Feedback

Myocarditis and Pericarditis After COVID-19 mRNA ...
Canadian Journal of Cardiology
https://www.onlinecjc.ca › article › fulltext
by A Luk · 2021 · Cited by 58 — The mRNA vaccines against COVID-19 infection have been effective in reducing the number of symptomatic cases worldwide.

Lower Myocarditis Mortality Following mRNA COVID-19 ...

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Mar 31, 2023 — Myocarditis mortality is higher in patients who have had a viral infection than in patients who have received an mRNA COVID-19 vaccine.

Myocardial Inflammation/Myocarditis After COVID-19 ...

European Society of Cardiology
https://esc365.escardio.org › presentation
Access this presentation on ESC 365 from ESC Congress 2022 on Myocarditis ... Myocardial Inflammation/Myocarditis After COVID-19 mRNA Booster Vaccination.
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