is...Long
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The news for CAR-T just gets worse every day. Despite all of the fanfare, it is going to be completely replaced with nontoxic efficacious autologous cost-effective dendritic cell vaccines like $NWBO DCVax...https://t.co/7fXPHf9Zl3https://t.co/KteWWzCGW5…
— Bio99 (@BIO99_BIO99) December 5, 2023
We await $NWBO submission with great excitement and interest, having invested a significant sum in it. When one is this excited, it is painful to have to wait for the perfect submission to be ready. It requires great patience. It might help with impatience though to look at the…
— Bio99 (@BIO99_BIO99) December 5, 2023
Professor Keyoumars Ashkan, Professor of Neurosurgery and Lead Clinician for Neuro-Oncology and Dr Ahmad Kamaludin, Clinical Research Fellow Neuro-Oncology, about ongoing research studies that can help with brain tumour diagnosis and treatment.
What is the importance of brain tumour research from your perspective?
Advancing our understanding of brain tumours through research is vital for improving treatment options and enhancing patients' quality of life. This is especially true for aggressive brain tumours like glioblastoma multiforme (GBM), the most lethal primary central nervous system tumour. With a survival rate of only 15 to 17 months and a 5-year survival rate of 5%, finding new treatment options is important. The current treatment options for newly diagnosed brain tumours including surgery, radiotherapy, and chemotherapy, have remained unchanged for the past 20 years, resulting in stagnant survival and mortality rates.
Developing effective treatments for complex brain tumours like GBMs is challenging due to their invasive nature, resistance to chemotherapy, and diversity. However, extensive research has led to significant progress in profiling GBMs based on specific mutations and patterns unique to each tumour, paving the way for personalised treatment options. Immunotherapy, such as DCVax, is an emerging option for mobilising the patient's immune system to fight against the tumour.
Introduction to DCVax, patient benefits, expectations and potential outcomes
DCVax is a new treatment option for GBM that uses a patient's immune system to fight cancer cells. It involves using dendritic cells, the master cells of the immune system, to educate the immune system to attack cancers. The treatment is well tolerated with few side effects, and it targets the spectrum of antigens in the patient's tumour by using the patient's tumour tissue to educate the immune system.
A Phase 3 clinical trial investigating the use of DCVax was published in JAMA Oncology in November 2022. The trial showed that DCVax improved the average overall survival of patients with methylated subtype of GBMs by 9 months (30.2 months vs 21.3 months) and of patients with unmethylated subtype of GBMs by about 3 months (19.3 months vs 16.5 months) when compared to the external control group. The 5-year survival rate was also higher in the DCVax group (13%) than in the control group (5.7%). Interestingly, the survival benefit was particularly pronounced in older patients.
The robust survival benefit of DCVax suggests that it should be considered for inclusion in the standard of care treatment for GBMs, especially given that no new systemic treatment since 2005 has demonstrated any significant survival benefit. Currently, DCVax is going through the process of appraisal required to obtain regulatory approval in the UK to make it available as part of the care for GBM patients.
#dcvax #allsolidtumors $nwbo #gbm pic.twitter.com/eIy7NDMZbD
— Peter Davis (@peter_brit) December 4, 2023
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 4, 2023
Recurrent Glioblastoma: A Review of the Treatment Options
Published: 26 August 2023
In the introduction, the article states that DCVax-L is one of the immunotherapy strategies that have been evaluated in clinical trials for recurrent…
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 4, 2023
RWD/RWE in 2023: Regulatory Policy World Tour
"RWD and RWE are beginning to meaningfully impact nearly every phase of the drug or therapeutic lifecycle. They can generate faster approvals and access to medicines, and bridge the gaps for… pic.twitter.com/diwlomkiH6
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 3, 2023
JOURNAL ARTICLE
CTIM-15. T CELL RESPONSE DYNAMICS IN PHASE 3 GLIOBLASTOMA PATIENTS IMMUNIZED WITH AUTOLOGOUS DENDRITIC CELLS PULSED WITH AUTOLOGOUS TUMOR CELL LYSATE Get access Arrow
Marnix Bosch, Linda Liau, Keyoumars Ashkan
Neuro-Oncology,…
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 3, 2023
To some extent, a key aspect of MHRA approval has 'fallen under the radar' in that it raises a very important question with regards to what will we be approved for ?
As we know, DCVAX® is the 'gift that keeps giving' and this is just another…
Special Issue "The Recent Updates in Primary CNS Tumors"
— Ida Bogac (@albtur_mnymkrs) December 2, 2023
“…vaccine therapies such as the recent DCVax trial for newly diagnosed glioblastomas have shown some encouraging results and are being actively investigated.$nwbo #dcvax https://t.co/dBZgoFmdKN pic.twitter.com/zTMMC3FMLf
#dcvax #allsolidtumors $nwbo #gbm https://t.co/gM4vBsvXZO
— Peter Davis (@peter_brit) December 3, 2023
Not at all, that is why I cross checked and provided alternative evidence to my post by means of providing the link to the UK MHRA guidance document which AI did not provide. (in my case) I would say, without doubt AI is useful as an addition... to a point .
Also, what cannot be overstated in terms of importance is that MHRA fast-tracked approval of $nwbo's PIP plan and allowed the trials to be the same design of the P3 trial.
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 2, 2023
The fact that we have already been awarded the PIM designation and in doing so have essentially met much of the criteria for approval, I honestly believe we will be approved quickly. Professor Ashkan stated in a video released recently that… https://t.co/DY2twbo6m5
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 2, 2023
"The PIM designation is the initial step in the EAMS and does not guarantee that DCVax-L will receive a scientific opinion or a marketing authorisation. However, it does indicate that DCVax-L has a high potential to be approved under the EAMS…
➡️FDA Approvals: CAR-T v. DCVax-L⬅️$NWBO
— hoffmann6383 (@hoffmann6383) December 1, 2023
CAR-Ts were approved despite serious adverse side effects. What does this say about DCVax-L's chances of FDA approval considering DCVax-L has a rather harmless safety profile and an already historically high chance of approval?
CAR-T… pic.twitter.com/cz9SA3Ld0v
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 2, 2023
"This revelation carries profound implications for the strategic approach of $NWBO, particularly in the development of autologous dendritic cell vaccines leveraging whole tumor lysate combined with checkpoint inhibitors. These vaccines, by… https://t.co/MDAYEtJprX
The link you have provided appears to have the date 7-29-22 ?
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 1, 2023
Interesting comments from MHRA on the subject of what considerations they are using with regard approvals.
Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023: This is a document that outlines the MHRA’s vision,…
Although DCVax® is not mentioned specifically, the article does acknowledge that cancer vaccines are one of the approaches to exploit innate immunity for cancer control, and that dendritic cells are the key players in initiating and regulating.
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 1, 2023
Exploiting innate immunity for cancer immunotherapy
Published: 27 November 2023
Ming Yi, Tianye Li, Mengke Niu, Qi Mei, Bin Zhao, Qian Chu, Zhijun Dai & Kongming Wu
Molecular Cancer volume 22, Article number: 187 (2023)
Although DCVax® is…
The article makes some excellent points leaving the big question, will Governments across the world mess this up? ....
'Generative AI could revolutionize health care — but not if control is ceded to big tech'
Excellent article 'Generative AI could revolutionize health care — but not if control is ceded to big tech'https://t.co/3E9BGnzslg
— Peter Davis (@peter_brit) December 1, 2023
Totally agree Gary and Yes I do believe the DCVAX-Direct trial could be considered a 'basket trial' I am not sure myself how many patients would be sufficient but I am sure others may know. I also believe that DCVax is tumor agnostsic and such 'basket trials' would IMO be a perfect showcase.
Bio99
@BIO99_BIO99
Just read an excellent just published review article by
@VivekSubbiah
on the potential, benefits and challenges of basket trials. Note to $NWBO investors that basket trials involving patients with tumors of all types are perfectly suited for DCVax and is what the company is planning next. In fact Dr. Subbiah was the primary investigator of the DCVax-Direct trial. Looking forward to learning about the design of the coming DCVax basket trials. They will no doubt include biomarker data which is the other thing besides basket trials that the FDA and NIH are promoting for all future cancer trials. Sorry that the review is behind a paywall so some will not be able to read it. But it is definitely the way forward. https://pubmed.ncbi.nlm.nih.gov/37934000/
#dcvax #allsolidtumors $nwbo #gbm https://t.co/zRfB62ymvy
— Peter Davis (@peter_brit) December 1, 2023
Bio99
@BIO99_BIO99
Every week in the clinic this feels bad as a provider. Immunotherapy benefits few but hurts many.
Biomarker development is not prioritized bc it would cut market share period. Would love to see @FDAOncology regulate this. twitter.com/ptarantinomd/s…
autologous assassin 🇺🇸 🇺🇦 🇮🇱
@flaskworks
Suddenly it seems that $NWBO's Landmark PIII Trial, which showcases DCVax efficacy and safety, sits above all other approved immunotherapies.
If patients could choose DCVax or similarly dangerous, expensive, treatments then what would they decide?
Exactly! $NWBO https://t.co/AGwBDg61sl
— Bio99 (@BIO99_BIO99) November 30, 2023
@BIO99_BIO99
Bottom line? Immunotherapies besides $NWBO DCVax are very toxic… biomarker requirements coming. We are well ahead of the curve…
#dcvax #allsolidtumors $nwbo #gbm https://t.co/AO4jUMDlp4
— Peter Davis (@peter_brit) December 1, 2023
Happy 25th Anniversary to the Musella Foundation! Check out the 2023 highlights and make a donation to show your support! @AlMusellahttps://t.co/ScAxtSr2sOhttps://t.co/172pjyNUPo#DCVax-L $NWBO https://t.co/SJ1i4KdYdT pic.twitter.com/G90TcV148T
— Henry (@HenryMuney) November 30, 2023
It's alright Regulators demonstrating they know this illegal activity is taking place on their watch but where is all the action apart from a 'slap on the wrist' allowing the offenders to have a good laugh and then go right back at it...😧
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) December 1, 2023
Whisskier@whisskier
🚨Why would the SEC post this on their webpage unless there is an issue in our markets with #Counterfeit Shares.... ?https://t.co/4IqruI8zIq pic.twitter.com/qIBeEeWxSI
How about all the price manipulation against $NWBO from #Citadel et al? https://t.co/IHSJE9D5XO
— Margaret Monson (@MonsonVO) November 30, 2023
Talk is cheap, if the SEC had used their current enforcement laws then there would be no such thing as spoofing which is essentially State/Regulator sanctioned despite being illegal, not to even mention dark pools and naked short shares. It cannot be a surprise that some are pushing for this, the likes of Griffin are not about to just go away quietly and he has plenty of money to ensure such legislative changes are put through. I have stated previously, this will be my last stock that I invest in on a US exchange. The UK Stock market is not perfect but Spoofing/Naked shorting not allowed to happen. I do not anticipate this happening in the US at any time soon. Daylight robbery and they are not even wearing a mask.
Supreme Court conservatives seem likely to axe SEC enforcement powers
Seriously ? Are they having a laugh 😅
Looking at our continued manipulation I don't see much evidence of any "SEC Enforcement"
Its even worse
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) November 30, 2023
1) Why have D.A.R not disclosed he was the coordinating principal investigator of a clinical trial for the company Inovio of which he presented Survival Results for INO-5401 + INO-9012 in Combination with Libtayo® (cemiplimab) in Patients with Newly Diagnosed ....
2)
— 🇩🇰 The Danish Dude 🇩🇰 (@FlemmingBruce) November 30, 2023
....GBM at ASCO Annual Meeting 2022?
He is also a Reardon is a member of Inovio's Scientific Advisory Board.
Why have he not disclosed he is the lead investigator for the company Enterome, for the OncoMimics ROSALIE Phase 1/2 trial of the drug EO2401 for rgbm?
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) November 30, 2023
A good example of exactly this deceit is the following:-
How can anybody think it is acceptable to not disclose, when attacking a treatment with incorrect information, that they have also designed and are running a trial that targets…
The possibilities and potential for Flasworks and EDEN are truly impressive. The acquisition by LP was simply genius.
Some possible applications for Flaskworks and Flaskworks EDEN devices, now owned by Northwest Biotherapeutics, are:
Manufacturing DCVax® personalized immune therapies for solid tumor cancers, such as glioblastoma, ovarian cancer, prostate cancer, and colorectal cancer with liver metastases. DCVax® uses the patient’s own dendritic cells, the master cells of the immune system, to create a vaccine that is tailored to their specific tumor. Flaskworks and Flaskworks EDEN devices can close and automate the manufacturing process of DCVax®, enabling substantial scale-up of production volumes and substantial reduction of production costs.
Manufacturing other types of dendritic cell therapies for various diseases, such as infectious diseases, autoimmune diseases, and allergies. Dendritic cells can be activated by different antigens or stimuli to induce specific immune responses against pathogens or harmful substances. Flaskworks and Flaskworks EDEN devices can isolate and differentiate dendritic cells from peripheral blood mononuclear cells, and load them with the desired antigens, using a synthetic peptide derived from the tumor-associated antigen EphA2, which is overexpressed in glioblastoma and other cancers.
Manufacturing other types of cell therapies, such as CAR-T therapies, NK cell therapies, and stem cell therapies, for various indications, such as hematological malignancies, solid tumors, and regenerative medicine. Cell therapies use living cells to treat or cure diseases by modifying their functions or characteristics. Flaskworks and Flaskworks EDEN devices can provide a platform technology that can be adapted to different cell types and processes, using a closed and automated system that can reduce contamination risks and human errors
"Recall as NCI director Dr. Monica Bertagnolli asked a budget of $10b to do something revolutionary. Instead of giving $10b which would be about 40% higher than last year, the congress only agreed to raise the budget by $500m which is 6.8% increase"
Politicians 'talk the talk' when it comes to 'finding a cure' until it comes to putting up the money. Just how much do they want to find a cure really ? Big pharma lobbying funds too tempting to ignore is likely the reality IMO
LP stated that the company would be "strategic" with their submissions. The choice of submitting to the UK MHRA first is part of that strategy IMO. A UK approval will put immense pressure on the FDA and also serve to put the company on a surer footing. As word spreads of the success with more and more patients being treated and Sawston ramp up initiated, voices from gbm patients and families in the US will become louder and louder.
Totally agree. As the company stated "The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators"
Quality is everything.
Now, not being medically trained myself I wanted to ask AI for relevance of Michael Bigger's response to d_stock's post "Can anyone say Tam/microglia" and got this really interesting response:-
Thank you for your question. I have searched the web for information about the relevance of TAM/microglia with DCVax platform technology. Here is what I found:
TAM/microglia are tumor-associated macrophages and microglia, which are the resident immune cells of the central nervous system (CNS). TAM/microglia can play a dual role in glioblastoma, the most aggressive type of brain tumor. On one hand, TAM/microglia can exert anti-tumor effects by producing pro-inflammatory cytokines, presenting tumor antigens, and activating T cells. On the other hand, TAM/microglia can also promote tumor growth, invasion, angiogenesis, and immune evasion by producing anti-inflammatory cytokines, suppressing T cell function, and inducing immunosuppressive cells1.
DCVax is a platform technology that uses dendritic cells (DCs) as a personalized immunotherapy for glioblastoma and other solid tumors. DCs are the master cells of the immune system, capable of activating T cells and other immune cells. DCVax uses the patient’s own DCs and tumor cell lysate, which contains a broad spectrum of tumor antigens, to create a vaccine that can induce a specific and robust immune response against the tumor234.
DCVax platform technology may have a positive impact on TAM/microglia in glioblastoma. According to a phase 3 trial of DCVax-L, a type of DCVax for glioblastoma, the vaccine not only activated T cells, but also increased the infiltration of T cells into the tumor tissue, where they could interact with TAM/microglia2. Moreover, DCVax-L may modulate the phenotype and function of TAM/microglia, shifting them from a pro-tumoral to an anti-tumoral state. For instance, DCVax-L may increase the expression of MHC class II molecules on TAM/microglia, enhancing their antigen presentation and T cell activation1. DCVax-L may also reduce the expression of PD-L1 on TAM/microglia, preventing their immune suppression and T cell exhaustion1. Furthermore, DCVax-L may alter the cytokine profile of TAM/microglia, increasing the production of pro-inflammatory cytokines, such as IFN-? and TNF-a, and decreasing the production of anti-inflammatory cytokines, such as IL-10 and TGF-ß1.
I find the use of AI in this 'Compare and contrast' method is particularly useful and in particular saves so much time similarly, being able to just put in a link to an article and for example ask if DCVax is referenced, again the time it saves having to read through it all is truly impressive.
Another very useful example of how it can really help with research is this example where I asked it to simply analyse Marnix Bosch's presentation on DCVax®-L:
Mechanism of Action, Immunological Effects, and Clinical Trial
External Controls Methodology
• The presentation explains the mechanism of action of DCVax-L, a personalized dendritic cell vaccine for glioblastoma and other solid tumors. DCVax-L is made from the patient’s own dendritic cells (DCs), which are the master cells of the immune system, and the patient’s own tumor cell lysate, which contains a broad spectrum of tumor antigens. DCVax-L is intended to activate the patient’s T cells to recognize and attack the tumor cells, while avoiding immune suppression by the tumor microenvironment1.
• The presentation shows the immune monitoring data from the phase 3 trial of DCVax-L for newly diagnosed glioblastoma (nGBM). The data demonstrate that DCVax-L induced a robust and durable immune response in the patients, as measured by the activation and expansion of T cells, the production of cytokines, and the infiltration of T cells into the tumor tissue. The immune response was also associated with the survival outcomes, as the patients who had higher immune activation had longer overall survival1.
• The presentation also describes the external controls methodology used in the phase 3 trial of DCVax-L for nGBM. The trial used external control patients (ECPs) as a comparator group, instead of a placebo group, due to ethical and practical challenges. The ECPs were derived from five other contemporaneous randomized clinical trials that used the same standard of care (SOC) as the DCVax-L trial. The ECPs were matched to the DCVax-L patients based on multiple prognostic factors, such as age, performance status, extent of resection, MGMT status, and IDH status. The presentation shows that the DCVax-L patients had significantly longer overall survival than the ECPs, with a median survival of 23.1 months vs 15.2 months, and a 3-year survival rate of 28.4% vs 11.3%1.
• The presentation also reports the observations from the compassionate use program of DCVax-L for recurrent glioblastoma (rGBM) and other solid tumors. The program enrolled patients who had exhausted all other treatment options and had a life expectancy of less than 6 months. The presentation shows that some of the patients who received DCVax-L had remarkable responses, such as complete or partial tumor regression, prolonged survival, and improved quality of life.
• The presentation concludes that DCVax-L is a promising immunotherapy for glioblastoma and other solid tumors, and that it has the potential to improve the survival and quality of life of patients who have limited treatment options. The presentation also states that the company is planning to pursue regulatory approvals for DCVax-L in the US and Europe, and to expand the clinical development of DCVax-L to other indications, such as ovarian cancer, prostate cancer, and colorectal cancer
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) November 29, 2023
In a nutshell...
I asked Microsoft's AI to provide the following response to the article by Ethan Chen, Alexander L Ling, David A Reardon, E Antonio Chiocca
Thank you for your question. I have analysed and commented on the article by Chen…
d_stock
@d_stock07734
"I suspect all the BPs in oncology field which are fond of immunotherapy will fall in love with NWBO. The only question is nowadays LP can be very picky. Take REGN for instance, Israel Lowy who is Senior VP Clinical Sciences, Head of Translational Science and of Oncology at REGN"
d_stock
@d_stock07734
"has very close collaboration with Dr. Thomas Marron
https://profiles.mountsinai.org/thomas-u-marron
Together they published plenty papers"
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C44&q=israel+lowy+%2B+thomas+marron&btnG=
profiles.mountsinai.org
Thomas Marron - Cancer (Oncology) | Mount Sinai - New York
d_stock
@d_stock07734
"Now take a look how many papers Dr. Thomas Marron coauthored with Andres Salazar. A lot!"
https://scholar.google.com/scholar?hl=en&as_sdt=0%2C44&q=Andres+salazar+%2B+thomas+marron&btnG=
"As a matter of fact, Dr. Thomas Marron is responsible for a clinical trial (the only one ongoing ) sponsored by Oncovir."
classic.clinicaltrials.gov
Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma - Full Text View - ClinicalTrials
#dcvax #allsolidtumors $nwbo #gbm pic.twitter.com/K96g3vm3dT
— Peter Davis (@peter_brit) November 29, 2023
Now with the latest FDA news, I doubt if REGN can still have the ambition of being the leader in immunotherapy. But REGN fall in love with DCVax-L. The future will be even better. Maybe Kevin Duffy already made the suggestion.https://t.co/a99mwXQcKJ
— d_stock (@d_stock07734) November 28, 2023
Not a good news for Regeneron which has big bet on chimeric antigen receptor (CAR) T-cell therapy. But it surely makes us love DCVax-L even more. Has DCVax-L bring to immune system anything artificially made? Did NWBO use synthetic this or that, or engineering this or that? None
— d_stock (@d_stock07734) November 28, 2023
Besides Regeneron, the list includes Abbvie, Adaptimmune, Amgen, Autolus, Bluebird Bio, Bristol-Myers Squibb, Celgene, Cellectis, CRISPR Therapeutics, Fate Therapeutics, Fortress Biotech, Gilead Sciences, Juno Therapeutics, Mesoblast, Novartis, Pfizer, Poseida Therapeutics,…
— Bio99 (@BIO99_BIO99) November 28, 2023
Good news for solid tumor cancer patients around the world, $NWBO #DCVax vaccine platform uses the patients own dendritic cells & immune system. DCVax is safe & non-toxic, unlike CAR-T therapies which use genetically modified T-cells & are very toxic, unsafe & very expensive… pic.twitter.com/odulYJ6Fnu
— ATLnsider (@ATLnsider) November 28, 2023