is...Long
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d_stock
@d_stock07734
we can ask ourselves the questions: Would this type of biomarker analysis be done for all the patients receiving DCVax-L? How many patients have received DCVax-L up to now? Has FDA seen the biomaker analysis or Will FDA review it? Has Merck or NCI reviewed the data like this?
#dcvax #allsolidtumors $nwbo #gbm https://t.co/HPMHd5LILR
— Peter Davis (@peter_brit) December 9, 2023
exploratory outcome measures. If anyone can find another similar one on the website, I'll diversify my investment. No such measures can be found in any other trials! Here is one of my favorite figures. Clearly the three patients from the figure came from the p3 trial. Now pic.twitter.com/LvQ1FFbuDt
— d_stock (@d_stock07734) December 8, 2023
d_stock
@d_stock07734
We don't need to predict anything. If we can predict, the dark forces can. If we can't, neither can they. One thing for sure. We are part of the revolution in which the clinical trials are purely biomarker-driven. Seriously take a look at the...
#dcvax #allsolidtumors $nwbo #gbm https://t.co/FMY2aSkBR6
— Peter Davis (@peter_brit) December 9, 2023
Please help support Mercy if you can, my heart goes out to her family, they're dealing with the most heartbreaking and devastating diagnosis.
— shitscaredmum (@shitscaredmum) December 8, 2023
Brain tumours are cruel & utterly random and could happen to any one of us. We desperately need more research & better treatment options. https://t.co/7Ur9BLf19a
Gracie’s #TikTok has now been seen by over 27 million people which is utterly mind blowing.
— shitscaredmum (@shitscaredmum) December 3, 2023
She’s made another one to explain the symptoms of brain tumours (as experienced by Laura).
A speedy diagnosis can be vital, so please know the signs @HeadSmartUK https://t.co/7gP1AeARNj
Friends is excited to host several important public events to kick off 2024. We hope you'll join us!
— Friends of Cancer Research (@CancerResrch) December 6, 2023
Register here: https://t.co/zXY1QtR6aj pic.twitter.com/72LEtxWTTs
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
Yet another reason why DCVax® development of personalized cancer vaccines designed to treat a broad range of solid tumor cancers is the best answer. pic.twitter.com/lGBk6yR2uG
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
US FDA, NCI Collaboration Deepens To Include Clinical Trial Innovation ‘Think Tank’
December 8, 2023
The US Food and Drug Administration and National Cancer Institute are collaborating to incubate clinical trial system improvements in an…
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
OurBrainBank is proud that the White House invited us to be part of the ambitious Cancer Moonshot effort. Here’s the latest from Washington DC and how everyone in the US can be involved whether by sharing stories, posting on social media (use…
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
Poster illustrating disparities in glioblastoma treatment presented at SNO, the premier neuro-oncology conferencehttps://t.co/briBpw1Roj pic.twitter.com/QOAAhBLMKK
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
Ensuring Regulatory-approved Treatments get to Patients Fast
NICE@NICEComms
Join a webinar for our response to@MHRAgovuk
IRP, and how you can ensure your treatments proceed optimally through NICE processes https://t.co/VQ8OMPYPyC 1 Jan,…
Bio99
@BIO99_BIO99
Oncolytic viruses, depending on who you talk to, are all the rage. But it's not guaranteed to work very well. See Replimmune's trial results this week. There are better ways to attack tumors and increase PD-L1 expression like $NWBO DCVax ... https://finance.yahoo.com/news/replimune-shares-initial-primary-analysis-120000897.html
#dcvax #allsolidtumors $nwbo #gbm https://t.co/kkUoHGASHl
— Peter Davis (@peter_brit) December 9, 2023
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 9, 2023
Al Musella@AlMusella
"Thanks for this very important update. Should make evaluation of progression more reliable"
RANO 2.0: Update to the Response Assessment in Neuro-Oncology Criteria for High- and Low-Grade Gliomas in Adults… pic.twitter.com/WMDwpCCCTp
When supply/demand sets the price where we don’t want it, we’ll spoof until the price is where our analysts have determine it should be?
— Justin Keister MS DABR (@justinkeister5) December 8, 2023
This is not how fair markets work. https://t.co/TjOpsUMgQV
Another KEYTRUDA combination failure (three reported in the last two days!)
Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma
December 8, 2023 6:45 am ET
Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)/MSI-H.
https://www.merck.com/news/merck-and-eisai-provide-update-on-phase-3-leap-001-trial-evaluating-pembrolizumab-plus-lenvima-lenvatinib-as-first-line-treatment-for-patients-with-advanced-or-recurrent-endometrial-carcinom/
Dr. Ichim, I have no doubt DCVax-L from NWBO can do a much better job in presenting viral antigens to immune system just like what it did in presenting tumor antigens. As shown in the slide, several viral antigens such as CMV and EMV were found in DC vaccine. pic.twitter.com/fhJFnkFvJq
— d_stock (@d_stock07734) December 7, 2023
Newly diagnosed patients, #DCVax-L provides 5-year
— rj (@sharpie510) December 7, 2023
double survival rate and reduced the risk of death by 20%. Relapsed patients, it reduced the risk of death by 42%.
👏
The DCVax® Platform
💪$nwbo #glioblastoma #CancerMoonshot @POTUS @FLOTUS @NIHDirectorhttps://t.co/N2bFQn52jR pic.twitter.com/sRdbMfGYj0
Bio99
@BIO99_BIO99
On Friday, the FDA is poised to approve the sickle cell CRISPR technology exa-cel. It was approved by the UK MHRA on November 16th. This is despite all of the legitimate off-target concerns that everyone has. The FDA is approving it only 22 days after the UK. Something to bear in…
#dcvax #allsolidtumors $nwbo #gbm https://t.co/RkogSvJOaP
— Peter Davis (@peter_brit) December 8, 2023
And another....
Merck Announces KEYLYNK-008 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus LYNPARZA® (olaparib) for Patients With Metastatic Squamous Non-Small Cell Lung Cancer to Stop for Futility
https://www.merck.com/news/merck-announces-keylynk-008-trial-evaluating-keytruda-pembrolizumab-plus-lynparza-olaparib-for-patients-with-metastatic-squamous-non-small-cell-lung-cancer-to-stop-for-futility/
Merck announces further failed KEYTRUDA combination results:-
"The results did not reach statistical significance (5.6 months vs. 3.2 months; HR=0.77 [95% CI, 0.53-1.13]; p=0.0910). Vibostolimab/pembrolizumab alone did not show an improvement in median PFS compared to docetaxel alone (2.7 months vs. 3.2 months; HR=1.40 [95% CI, 0.96-2.02]; p=0.9622).
https://www.merck.com/news/merck-announces-findings-from-phase-2-keyvibe-002-trial-evaluating-an-investigational-coformulation-of-vibostolimab-and-pembrolizumab-in-previously-treated-patients-with-metastatic-non-small-cell-lung/
Gregory Zivic, MD
@metacollectiveG
Ain’t that the truth. In $NWBO ‘s case I find the current attempts to hold the price down indicative of news next week. Even Midwest Hedgie bragged he could cover his short position easily in a day. They’d want it as low as possible and then after covering buy INTO the news.
#dcvax #allsolidtumors $nwbo #gbm https://t.co/L9QkTKogXT
— Peter Davis (@peter_brit) December 7, 2023
the immune response. I was wondering if you as an expert has seen anything like this. Thank you. pic.twitter.com/tJgUC6h30D
— d_stock (@d_stock07734) December 6, 2023
#dcvax #allsolidtumors $nwbo #gbm https://t.co/rr8sWdB8tF
— Peter Davis (@peter_brit) December 7, 2023
T regulatory cell depletion can restore post-vaccination antibody production in rats endogenously expressing the antigen.
— Dr. Thomas Ichim (@exosome) December 6, 2023
To cure #cancer you need to break tolerance...this is what $NWBO is doing with dendritic cells$TSOIhttps://t.co/fKMgLF6C8F
$NWBO As an aside I urge all of you to write your US Representatives and Senators regarding @AlMusella ‘s bill “The Promising Pathway Act”. This is important and extremely relevant in today’s regulatory environment that protects Big Pharma over innovative start up biotech. pic.twitter.com/UIIHK7UT9U
— Gregory Zivic, MD (@metacollectiveG) December 6, 2023
Bio99
@BIO99_BIO99
Manufacturing, manufacturing, manufacturing... That's why $NWBO cares so much about it and the details of its submissions... Nothing is being left to chance.
#dcvax #allsolidtumors $nwbo #gbm https://t.co/amRv6UCfGq
— Peter Davis (@peter_brit) December 7, 2023
#dcvax #allsolidtumors $nwbo #gbm https://t.co/VF5CZao6dm
— Peter Davis (@peter_brit) December 6, 2023
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 6, 2023
"The DCVax-L - the treatment Hannah and Gail want to access in the US - is a type of immunotherapy vaccine for glioblastoma. The manufacturer says clinical trials have extended patients' lives by over 10 years"https://t.co/jU5J9a05jV
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 6, 2023
Along with the UK's 'Access Consortium' the 'International recognition procedure' will also be important for DCVax® going forward, Even if not used for the first MHRA approval, I am sure these programs and Project Orbis will prove to be…
#Flaskworks patent issuance payment on November 21, 2023 🇸🇬 SG11202104962QA - "Dendritic cell generating apparatus and method". $NWBO
— Henry (@HenryMuney) December 5, 2023
Next step, patent grant (issuance). pic.twitter.com/KEfaIvTSVk
➡️@VirtuFinancial's Growing Legal & Regulatory Concerns⬅️
— hoffmann6383 (@hoffmann6383) December 5, 2023
Q3 '20 10Q dated November 6, 2020 [1]
(hereinafter "'20 10Q")
Legal & Regulatory Matters: See Image 1.
Q3 '23 10Q dated November 2, 2023 [2]
(hereinafter "'23 10Q")
Legal & Regulatory Matters: See… pic.twitter.com/52ksAHXRXE
Gregory Zivic, MD
@metacollectiveG
$NWBO Based on tons of research; the company is keeping their mouths shut despite cries of no institutional buyers, no media exposure, etc. I believe it’s because they’re doing it all behind tightly sealed doors. Those they’re talking with have seen what’s been built.
#dcvax #allsolidtumors $nwbo #gbm https://t.co/kBe0MkM9Pm
— Peter Davis (@peter_brit) December 6, 2023
I don't have a problem with genuine 'mistakes' being made even by AI however, these so-called medical 'Professionals' who are writing these 'hit' pieces and are subsequently found to have significant 'conflicts of interest' need to be called out every single time. I simply refuse to believe that the researchers are that inept and negligent to make the many mistakes they have done, especially with the timing being suspect. If you look at the company's who are paying these authors, it is not at all a coincidence that they are companies in direct competition to DCVax® Every 'mistake' and conflict of interests should be scrutinized and reported accordingly. As I have stated, I have e-mailed the main author and asked that they amend the article asap.
We truly live in totally messed up world! 😡Humanity does not need to worry about Meteorites/Asteroids, Solar flares, Climate change, Natural disasters, plagues/pandemics or Aliens being the cause of extinction. Greed, corruption, war and the power struggle to control global resources both on and off our planet will suffice. Other ancient civilizations may have become extinct but Modern human beings could be the first to knowingly cause our own demise and essentially die of STUPIDITY.
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 5, 2023
It is going to be really interesting when $nwbo submits approval application to Health Canada. There is good reason why $nvcr pps has dropped from $220 to $13.30 in just 2 years.
"Health Canada has granted approval for the treatment of…
Exactly and the fact they are stating PFS as being the primary endpoint is testimony to this, as with all these type of attacks the conflict of interests statements are telling. The timing of these recent attacks is also very telling as well as their sheer desperation.
I have sent the following to the article's main author:-
Dear Marta,
I would like to bring to your attention the following mistakes made in your recently published article, please amend the article and confirm as soon as possible
Maccari et al. state that DCVax-L is “a vaccine composed of autologous dendritic cells loaded with tumor lysate from the patient’s own tumor” (page 2). This is correct, but they do not mention that DCVax-L also contains granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine that stimulates the maturation and activation of dendritic cells. Maccari et al. also state that DCVax-L is “administered intradermally every 2 weeks for 3 doses, then every 2 months for 6 doses, and then every 3 months until the vaccine is exhausted” (page 2). This is partially correct, but they omit the fact that DCVax-L is also given intradermally at the time of surgery, before the start of standard of care (SOC) treatment with radiotherapy and temozolomide1. Maccari et al. claim that DCVax-L “showed a median overall survival of 23.1 months in the treated group versus 15.2 months in the control group” (page 2). This is incorrect, as the median overall survival in the treated group was 23.1 months versus 16.6 months in the control group, according to the latest published results. Moreover, they do not specify that the control group received SOC plus placebo, and that some of the control patients crossed over to receive DCVax-L after tumor recurrence1. Maccari et al. also claim that DCVax-L “increased the percentage of long-term survivors (>36 months) from 6.8% to 16.8%” (page 2). This is incorrect, as the percentage of long-term survivors (>36 months) was 16.8% in the treated group versus 5.7% in the control group, according to the latest published results. Liau et al. state that DCVax-L is “a personalized vaccine consisting of autologous dendritic cells loaded with tumor lysate from the patient’s own tumor and granulocyte-macrophage colony-stimulating factor” (page 113). This is correct, and they provide more details about the manufacturing process and the dosing schedule of DCVax-L than Maccari et al. (pages 113-114). Liau et al. also state that DCVax-L “demonstrated a median overall survival of 23.1 months in the treated group versus 16.6 months in the control group” (page 113). This is correct, and they also specify that the control group received SOC plus placebo, and that 64 of the 99 control patients crossed over to receive DCVax-L after tumor recurrence (pages 113-114). Liau et al. also state that DCVax-L “increased the percentage of long-term survivors (>36 months) from 5.7% to 16.8%” (page 113). This is correct, and they also report the survival rates at other time points, such as 24 months, 30 months, and 60 months (pages 113-114).
Also, with regards to the following comment:-
absence of information regarding the stated primary endpoint of the study which was PFS
The endpoints were pre-specified and changed prior to unblinding so PFS was NOT the primary endpoint
Design, Setting, and Participants This phase 3, prospective, externally controlled nonrandomized trial compared overall survival (OS) in patients with newly diagnosed glioblastoma (nGBM) and recurrent glioblastoma (rGBM) treated with DCVax-L plus SOC vs contemporaneous matched external control patients treated with SOC.
https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847
I asked Microsoft AI to do a 'compare and contrast' with JAMA P3 results article and to list mistakes made Maccari et al article, says it all really...
The article by Maccari et al. and the article by Liau et al. are both reviews of the current status and future prospects of immunotherapy for glioblastoma, a highly aggressive and lethal brain tumor. However, there are some differences and mistakes in the comments referring to DCVax-L, a personalized dendritic cell vaccine that has been tested in a phase 3 clinical trial for glioblastoma patients. Here are some of them:
Maccari et al. state that DCVax-L is “a vaccine composed of autologous dendritic cells loaded with tumor lysate from the patient’s own tumor” (page 2). This is correct, but they do not mention that DCVax-L also contains granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine that stimulates the maturation and activation of dendritic cells1.
Maccari et al. also state that DCVax-L is “administered intradermally every 2 weeks for 3 doses, then every 2 months for 6 doses, and then every 3 months until the vaccine is exhausted” (page 2). This is partially correct, but they omit the fact that DCVax-L is also given intradermally at the time of surgery, before the start of standard of care (SOC) treatment with radiotherapy and temozolomide1.
Maccari et al. claim that DCVax-L “showed a median overall survival of 23.1 months in the treated group versus 15.2 months in the control group” (page 2). This is incorrect, as the median overall survival in the treated group was 23.1 months versus 16.6 months in the control group, according to the latest published results1. Moreover, they do not specify that the control group received SOC plus placebo, and that some of the control patients crossed over to receive DCVax-L after tumor recurrence1.
Maccari et al. also claim that DCVax-L “increased the percentage of long-term survivors (>36 months) from 6.8% to 16.8%” (page 2). This is incorrect, as the percentage of long-term survivors (>36 months) was 16.8% in the treated group versus 5.7% in the control group, according to the latest published results1.
Liau et al. state that DCVax-L is “a personalized vaccine consisting of autologous dendritic cells loaded with tumor lysate from the patient’s own tumor and granulocyte-macrophage colony-stimulating factor” (page 113). This is correct, and they provide more details about the manufacturing process and the dosing schedule of DCVax-L than Maccari et al. (pages 113-114).
Liau et al. also state that DCVax-L “demonstrated a median overall survival of 23.1 months in the treated group versus 16.6 months in the control group” (page 113). This is correct, and they also specify that the control group received SOC plus placebo, and that 64 of the 99 control patients crossed over to receive DCVax-L after tumor recurrence (pages 113-114).
Liau et al. also state that DCVax-L “increased the percentage of long-term survivors (>36 months) from 5.7% to 16.8%” (page 113). This is correct, and they also report the survival rates at other time points, such as 24 months, 30 months, and 60 months (pages 113-114).
1: Liau et al. Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma: A Phase 3 Prospective Externally Controlled Cohort Trial. JAMA Oncol. 2023;9(1):112-1212
$NWBO Here’s the thing: everyone is missing that this is a lock and falling prey to every move of the needle day to day. You’re excited we go up 12% thinking “something must be up!” We drop, “Oh shit, what’s wrong?!” Have faith in what you know, you’re not wrong. Relax.
— Gregory Zivic, MD (@metacollectiveG) December 5, 2023