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Academy Friend
LUMICKS
EnrichBiosystems
Northwest Biotherapeutics
“George Zavoico, PhD
Northwest Biotherapeutics”
Guess you are right .As I said last week also the presentations are of zero relevance from SP standpoint without approval.
And it's not. Down on high volume as usual. Nothing changes here except mute ineptness.
I guess you are right
KevGee,
It doesn't take much money to swing this stock either direction, at present.
Can you imagine if you you had billions of dollars to through down at will...
This will change.
tbu
In anticipation of news...nothing. 🙄
Confirmed not the right direction.
See y'all next week.
Going red. 20-30 million in volume is need to move this a couple of cents
It was up 17.7% at stuttgart. Usually not much of a predictor , but let's see.
Unusually large premarket volume. Over 60k. I'll take it. Hopefully heads the right direction.
It’s the old Bavituximab but in reverse! They spent the first twenty years on virology then when that all failed moved to oncology.
Could today's presentation by Dr. Bosch be about DCVax-Direct? According to the last SEC filing, yes.
Quarterly:
Enhanced DCVax-Direct Products and Upcoming Presentation. The Company continued its internal testing of certain immune booster agents that it has in-licensed, to identify the most useful booster agent(s) and combination(s) of agents for enhanced DCVax-Direct products. The Company currently anticipates making a presentation about this at a scientific conference in June. The Company is also in discussions with clinicians about which version(s) of enhanced DCVax-Direct products should be selected and for which cancers for the initial clinical trials.
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) June 16, 2025
Reminder : Today...
SESSION IV: Industry Blitz
Session Chair: Renier Brentjens, PhD, Roswell Park Comprehensive Cancer Center
2.50 PM Next Generation Dendritic Cell Treatments to Improve Anti-Tumor Responses
Marnix Bosch, PhD, Northwest Biotherapeutics… pic.twitter.com/hbXiTdTCg0
#dcvax $nwbo #gbm pic.twitter.com/T8gBEcj9uc
— Peter Davis (@peter_brit) June 14, 2025
Slave1, thanks for the answer. I thought I might have missed something. Yes, the company has said it will use this UK MAA as a base for applications to multiple other markets, including the US, Canada, and Europe, which make up the other companies where we ran clinical trials. And yes, there's been a lot of projection on this board that we're using a rolling application. Thanks for pointing out how our actions align with a rolling submission.
We'll know soon.
Gary, I agree with you that CRL (Charles River Labs) will likely play a big role in manufacturing clilnical trial vaccines and commercial vaccines. It appears they have over 50 labs in the US! I would not be surprised if they're the only one. In the SEC filings, the company refers to discussions with "facilities" and "parties", but never uses the word "companies" iin the plurual form. So, will it be several "facilities" of CRL?
We'll know soon enough.
And yes, congrats! you may have nailed it with your EDEN call :
under substantial criticism years ago I indicated that EDEN's could be distributed all over the world in small numbers and the vaccine be made at or near where it was to be used.
Interesting Robert M. Prin's co-authored article with AI Analysis on potential synergy with DCVax technology platform..
Dissecting the immune landscape in pediatric high-grade glioma reveals cell state changes under therapeutic pressure :
May 20, 2025
Conclusion :
"The findings of the article on immune landscape changes in pHGGs under therapeutic pressure, particularly with ICB, are likely to have synergy with DCVax-L, given their complementary mechanisms in immunotherapy. Combining DCVax-L with ICB could potentially improve treatment outcomes by enhancing immune activation and overcoming tumor-induced immunosuppression, with the article's insights aiding in optimizing such combinations. However, further research is needed to confirm specific synergies and clinical benefits, especially given the complexity of glioma immunotherapy"
AI Analysis :
Key Points
Research suggests the article's findings on pediatric high-grade gliomas (pHGGs) could synergize with DCVax-L, a dendritic cell vaccine for glioblastoma.
It seems likely that combining DCVax-L with immune checkpoint blockade could enhance immune responses, potentially improving treatment outcomes.
The evidence leans toward potential benefits, but more specific studies are needed to confirm synergy and effectiveness.
Background
The article, published in Cell Reports Medicine in 2025, explores how the immune environment in pHGGs changes after treatments like chemotherapy, radiotherapy, and immune checkpoint blockade. DCVax-L, developed by Northwest Biotherapeutics, is an immunotherapy that uses dendritic cells to stimulate the immune system against glioblastoma, a type of high-grade glioma.
Potential Synergy
Both approaches aim to boost the immune system against cancer, but they work differently. DCVax-L activates immune cells to attack tumors, while immune checkpoint blockade removes barriers that cancer cells use to evade the immune system. The article's findings on immune changes could help optimize how these therapies are combined, potentially leading to better results for patients.
Implications
Combining these treatments might improve survival rates or extend remission for glioma patients, but the exact benefits depend on further research into how the immune landscape shifts and interacts with DCVax-L.
Survey Note: Detailed Analysis of Article Findings and DCVax Technology Synergy
This survey note provides a comprehensive analysis of the potential synergy between the findings of the article "Dissecting the immune landscape in pediatric high-grade glioma reveals cell state changes under therapeutic pressure" (DOI: S2666-3791(25)00168-5) and DCVax technology platforms, particularly DCVax-L, in the context of treating high-grade gliomas. The analysis is grounded in the current understanding of immunotherapy for gliomas and draws on extensive research to explore potential combinations and their implications.
Article Overview and Findings
The article, published in Cell Reports Medicine on an unspecified date in 2025, focuses on pediatric high-grade gliomas (pHGGs), which include aggressive brain tumors like glioblastoma multiforme (GBM). It employs single-cell RNA sequencing to analyze changes in the immune microenvironment following treatments such as chemotherapy, radiotherapy, and immune checkpoint blockade (ICB). The study aims to elucidate why pHGGs often respond poorly to conventional therapies, highlighting shifts in tumor cells, T cells, and myeloid cells under therapeutic pressure. The description from the search results indicates that the research might help explain the limited efficacy of current treatments, particularly in the context of ICB, which is a form of immunotherapy that enhances T-cell activity by blocking inhibitory signals like PD-1/PD-L1.
Given the focus on ICB, the article's findings are particularly relevant to understanding how the immune landscape can be manipulated to improve outcomes. For instance, it may identify specific immune cell populations or markers that are altered post-treatment, which could inform combination strategies with other immunotherapies.
DCVax Technology: Mechanism and Application
.DCVax, developed by Northwest Biotherapeutics, is a platform technology based on dendritic cell vaccines, with DCVax-L being the lead product for GBM. Dendritic cells are critical immune cells that present antigens to T cells, thereby initiating an immune response. DCVax-L is personalized, using autologous dendritic cells pulsed with tumor lysate to educate the immune system to recognize and attack cancer cells. Clinical trials, such as the phase III trial reported in JAMA Oncology in 2022, have shown that DCVax-L can extend survival when added to standard chemotherapy, with some patients achieving median overall survival of up to 40.5 months in extended survivor groups
The technology is designed to mobilize the entire immune system, not just specific components, by leveraging dendritic cells as "master cells" that activate multiple immune agents, including T cells and cytokines. This broad activation contrasts with some other immunotherapies that target single antigens or pathways, making DCVax-L a promising candidate for combination with other modalities.
Potential Synergy with Article Findings
.The synergy between the article's findings and DCVax-L lies in their shared goal of enhancing the immune response against gliomas, albeit through different mechanisms. The article's focus on ICB aligns with DCVax-L's immunotherapy approach, as both aim to overcome the immunosuppressive tumor microenvironment (TME) characteristic of gliomas. The TME in GBM is known for high levels of immune suppression, including overexpression of inhibitory cytokines, low HLA expression, and elevated T-regulatory cells, as noted in research from Frontiers in Immunology
Immune Checkpoint Blockade and DCVax-L:
ICB, such as anti-PD-1 therapy, works by releasing the brakes on the immune system, allowing T cells to attack cancer cells more effectively. DCVax-L, on the other hand, primes the immune system by activating dendritic cells to present tumor antigens, potentially increasing the number of T cells available to target the tumor. Combining these could create a synergistic effect: DCVax-L could enhance T-cell activation, while ICB could prevent tumor-induced immune suppression, as suggested in a case study combining dendritic cell vaccines with anti-PD-1, where a patient remained disease-free for 69 months
Article's Contribution to Combination Strategy:
The article's findings on immune cell state changes post-ICB could provide critical insights into how to sequence or combine DCVax-L with ICB. For example, if the article identifies upregulation of PD-L1 on myeloid cells after ICB, this could suggest that adding DCVax-L at that stage might enhance T-cell responses by providing more activated dendritic cells to present antigens. Conversely, if certain immune populations are depleted, DCVax-L could be used to replenish or boost those populations.
Evidence from Related Research: The field of glioma immunotherapy supports the combination of dendritic cell vaccines with ICB. A review in Journal of Experimental & Clinical Cancer Research highlights that combination strategies, including dendritic cell vaccines and ICB, have shown encouraging results in preclinical and clinical studies, addressing different arms of immunity to overcome the immunosuppressive TME. Another study in eBioMedicine notes that therapeutic vaccines can boost the efficacy of ICB, suggesting that diverse antigen presentation (as in DCVax-L) could enhance ICB's effectiveness
Potential of the Combination
The potential benefits of combining DCVax-L with ICB, informed by the article's findings, include:
Enhanced Immune Activation: DCVax-L could prime the immune system, while ICB could sustain and amplify this response by preventing immune evasion, potentially leading to more robust tumor control.
Overcoming Resistance: Gliomas are known for their resistance to single-agent immunotherapies due to their immunosuppressive environment. Combining approaches could address multiple resistance mechanisms, as suggested in research on multimodal immunotherapies
Improved Patient Outcomes:
Clinical evidence, such as the extended survival seen in some DCVax-L trials and case studies with ICB combinations, suggests that such strategies could improve survival rates or extend remission periods, particularly for patients with newly diagnosed or recurrent GBM.
However, challenges remain, including the need for optimized sequencing, dosing, and patient selection, as well as addressing potential toxicities from combining immunotherapies. The article's findings could help identify biomarkers or immune profiles that predict response to such combinations, guiding personalized treatment strategies.
Conclusion
The findings of the article on immune landscape changes in pHGGs under therapeutic pressure, particularly with ICB, are likely to have synergy with DCVax-L, given their complementary mechanisms in immunotherapy. Combining DCVax-L with ICB could potentially improve treatment outcomes by enhancing immune activation and overcoming tumor-induced immunosuppression, with the article's insights aiding in optimizing such combinations. However, further research is needed to confirm specific synergies and clinical benefits, especially given the complexity of glioma immunotherapy.
https://cell.com/cell-reports-medicine/fulltext/S2666-3791(25)00168-5
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) June 16, 2025
Interesting Robert M. Prin's co-authored article with AI Analysis on potential of DCVax technology platform..
Dissecting the immune landscape in pediatric high-grade glioma reveals cell state changes under therapeutic pressure :
May 20, 2025
Conclusion :… pic.twitter.com/s8H9frVHX3
Gregory Zivic, MD
@metacollectiveG
$NWBO This is what BP and Wall Street want to know.
$NWBO This is what BP and Wall Street want to know. https://t.co/o9ukxXARMH pic.twitter.com/3shos9eJt2
— Gregory Zivic, MD (@metacollectiveG) June 15, 2025
Rather, a company would be foolish to dilute for months in .20s, and for years in pennies! You apply to the world’s biggest and most profitable biotech market regardless of whether you can make 100 or 1000 doses per year in the first year or two. This is how you build investor support and credibility. And not do nothing for 5 years (since data lock) around US commercialization. Eden is not important at all for FDA and wont even get approved in 2026. KITE was only able to produce doses for 100 patients post FDA approval in the first year.
You don't waste years, complain that you can’t raise money when you can apply to FDA, get approval, raise lots of money at much better valuation and accelerate your commercialization journey including progress on Eden with more resources. LP & LG have lied to shareholders about FDA and couple of other things, and she is going to get sued later this year. Just wait and watch!
I call BS, if you really are such a person, you have more than enough money and don't need to waste your life here.
The real question to ask is why have the folks that have lost over 95% value since the last 10-15 years still continue to post here. At least, Ex, LC, IC, and his crew have made a ton of money during these years. Why would they stop when LP continues on an endless dilution journey? It will be very easy and quick money for them once again for the hundredth time at whatever (limited) spike we may get at UK approval.
Whats the incentive for the LP’s gang of minions who have been posting for a decade or so when ROI & opportunity cost does not factor into their decision making? Paid pumpers? If so, are they paid by big warrant holders or one of LP and LG’s hired marketing/consulting firm?
In terms of Ex, LC, IC, and his buddies, it’s evident that they continue to see tremendous opportunity to make a ton of money and they have been extremely successful over the last 15 years and will very likely be for another several years as LP recruits new bag holders and dilutes NWBO to oblivion! Maybe they are part of MMs or hedge funds paid crew but these folks are good at spotting companies like NWBO that does nothing but complain, have victim mindset, move goalposts, lie, continue to do down roads, have no major institutional and credible media support. Because they are a bunch of unethical folks who have lost so much of shareholder wealth over the last 15 years. Thats a fact!
New request for a raise in authorized share count is coming later this year. Just wait and watch!
Ha Ha. How far they fall. Now posting negative comments non stop on an OTC stock. Jeez what an important person one has to be to do that.
I really don't know if anyone here knows precisely how Orbis works, or if we're in it. If we are in it, applying for UK approval may have been exactly what we were asked to do.
The 20 tiny cleanrooms at Sawston were sufficient for the UK to accept the filing, while if in Orbis, the EDEN was part of what had to be approved.
I'm not saying this is the case, just that it could be a possibility, and we really wouldn't know.
Gary
LinkedIn?
I'm a ceo of a global bs company
"Especially since they clearly told NWBO not to bother filing"
False bs
How do you know this. FDA never told you. May be its pursuing the bla as a part of project orbis. No one knows about one way or the other. Same thing with your statement of non funding in uk. Dont give that bull about i have vast experience in regulatory filings. The fact of the matter is you are a bear lurking in a otc ticker to decimate or harm the company. Its all your bear opinion for now.
20+ years in biopharma world, key member of a team that launched the most successful drug ever (at the time), new product strategy consultant with most of the top 10 pharma companies and many new product and the largest drugs.
Nothing like an FDA conspiracy theory!!! Especially since they clearly told NWBO not to bother filing. MHRA may approve DCVax-L but they won't fund it and it won't get much uptake. Costs waaaay to much to make -- few can afford cash, and NICE won't pay any or very few from the NICE charity just like CAR-T in UK.
Sad to watch the wishful thinking.
Hey beartrap, great question, and I appreciate how you asked it.
You’re right that “rolling BLA” doesn’t appear in any official filing like the 10-Q. I think what’s happened is that people (myself included) have started using that phrase as a kind of shorthand, not because NWBO formally said it, but because the steps they’re taking line up with what companies usually do before they submit a rolling BLA.
Your theory is actually spot-on: the consultant prep you’re referring to, reviewing the MHRA submission and identifying what can transfer to the FDA, is exactly the kind of thing that would happen before a rolling BLA is even authorized. And we know from the 10-K:
“We depend to a significant extent on third parties and outside consultants for… regulatory advisory services, including preparation of regulatory submissions.”
That’s “submissions,” plural, which strongly implies they’re working on more than just the UK. It’s likely the UK MAA is serving as the foundation for an FDA filing, and they’re figuring out what needs to be adjusted. That’s how this process usually works.
Also, they stated:
“We plan to apply for Fast Track status.”
- Which is a prerequisite for rolling BLA acceptance by the FDA.
And from the shareholder meeting:
“We will continue to be subject to the FDA, the U.K. MHRA, the EMA, and other regulatory requirements.”
That’s not just boilerplate, they’re highlighting ongoing coordination with multiple agencies, including the FDA.
So no, it’s not in a press release or quarterly, but the groundwork is clearly there, and the idea of a rolling BLA likely comes from connecting those dots. I’d say your explanation is probably the most accurate interpretation of what’s really happening behind the scenes.
Happy Father's Day!
Wow, got the whole conspiracy theory thing going!!! Sorry, FDA saw the dubious trial and said, sorry don't bother filing. That's what happens when questionable trials are all a drug has -- and that's DCVax-L. Even MHRA has been doing RFIs as the data is still questionable and takes NWBO forever to get anything done, just like the trial. Just watch the share price keep sliding again after the stock pumpers just hyped the "approval" that never came.
The lawsuit continues moving toward discovery. Personally I still think the MM's may offer something before anyone gets to look in their books. I suspect that if that's the case it will be negotiated to a price acceptable to Posner, as well as the company.
If I'm wrong about that, the calendar takes it well into next year, and probably beyond if the MM's delay on every occasion they can.
As for AdamF, we may hear from him after Dr. Bosch's presentation. Until we've heard what Dr. Bosch has to say it's hard to say how AdamF will distort it. I really don't know if the 85 to 1 actually came from him, or elsewhere, it sounds so foolish that even he wouldn't put it out there, but if he did, so be it, nothing he says should be taken seriously, especially when it comes to what's clearly his hatred of NWBO.
Gary
The law suit is moving on to discovery. A proposed schedule has been presented to the judge I think.
Decision by 2027, if then. Forget about it, all that matters is approval or failure, boom or bust is the longs fate. Wonder where Adam Asshat got this 1 for 85 split info from. The thing is, he knew cvms drug trial had failed before it was announced. He has a rat inside somewhere.
Gary, Database makes sense, a bit of gold standard there in real world evidence and to adjust tentative labels accordingly. That should help better therapies to remain, less effective ones to fade, and for medicine to more quickly converge onto the best therapies for patients. Advantage DCVax, as it validates itself across tumor types (DCs are agnostic) and cancer stages (same biological mechanism) and optimizes for the best therapeutic combinations.
With new trials coming, hopefully before year's end, I believe they could be conducted with EDEN's positioned at every clinical site. I feel almost certain that they wouldn't use manual capacity at Sawston to make the vaccine and potentially deprive a paying customer. It's my belief that most, if not all, the facilities who worked on the prior Phase 3 would have the equipment needed to make and properly store the vaccine for all patients in the trial. All that should be needed is a little training for the staff on the use of the EDEN. I welcome other thoughts on how new trials should be run.
Gary
I could be wrong, but I've always believed that LP has some agreement with CRL to at least be one of many CDMO's if she chooses to go that route. If she can make a better deal nothing is locked in concrete, but with CRL's size I believe they could support nearly all the world if they determined to go that way.
I should also indicate that under substantial criticism years ago I indicated that EDEN's could be distributed all over the world in small numbers and the vaccine be made at or near where it was to be used. Each unit would be leased, FlaskWorks would monitor every use and be responsible for its continued proper operation. Every disposable cassette would be tracked until after making its one batch of vaccine it was disposed of. I'm not saying it will happen this way, just that it's a possibility.
Gary
Is everyone ready for the end of spring nothing burger tomorrow. ??? Eagle and the rest of the minions have been loading up the board this weekend in an attempt to overshadow the disappointment that will come out of the 15 minute conference.
Shorts are gonna make another bundle off of this one. Imo
Prediction, SP will go north initially relatively heavy volume, then will drop like a cheap suit in a rain storm the next day.
Ex.
I don't know when a biotech becomes a BP.
AMGN initially was certainly a biotech, even today while it's as big as a BP, I believe its approach is somewhat different from the average BP, however I suspect most would call it a BP today.
I believe in terms of earnings, if NWBO remain independent and if both DCVax's are approved as tumor agnostic products, then NWBO's earning could be the equal or greater than most of the BP's.
I'm not suggesting that every patient with a solid tumor would get one or both products, but many would. That would be a whole lot of patients, they wouldn't have to receive that much per patient to be bringing in well into double digit billions annually in earnings. With a P/E of 30 they just might be a trillion-dollar market cap company.
Gary
Slave1, I believe that the fact that NWBO zeroed in on Roswell, proboably aDCi research, being the first we would pursue in the US, does not mean that Linda is not thinking 5 steps ahead to when we need large scale manufacturing for manufacturing DCVax-L. Doc Logic suggested that we need to have manufacturing squared away in the U.S. first, before we can apply for a BLA. I think Linda is doing that now, and may already have it done. In the last quarterly report, it said:
Manufacturing in the US. The Company continued its discussions with GMP facilities in several states to obtain capacity and availability for potential manufacturing in the US. The Company anticipates reaching an agreement during this summer. The manufacturing is initially contemplated to include DC products involving the IP in-licensed from Roswell Park and the University of Pittsburgh, and then DCVax products.
Potential Manufacturing in the US.
During much of 2024 and Q1 2025, the Company has been in discussions with a series of half a dozen independent parties with GMP facilities in diverse areas of the US, to obtain capacity and availability for potential manufacturing in the US. The manufacturing is initially contemplated to include DCVax-L products and DC products involving the IP in-licensed from Roswell Park and the University of Pittsburgh.
Chiugray,
My version of a Phase 4 is really a database in which all uses of the product are reported. If nothing unusual occurs the prescribing physician only needs to check of a box in the database. If something unexpected occurs, it would be reported in greater detail. It needs to be recognized that we're dealing with very deadly disease, death wouldn't be an unexpected consequence if it was expected, it would be if it wasn't, especially if it occurred shortly after getting the vaccine. If it were up to me, the patient too would be able to comment in the database, but no one would be identified by name, a unique prescription number would be applied that the Dr. and patient would have.
Essentially the Phase 4 would stay in place for years, the FDA could establish when to remove it, or if something was found that required further investigation, or perhaps a label change. Worst case, if something really negative turned up, a product could be taken off the market.
Gary
That's a flawed assertion . 10 years ago how many shares did retail hold 50M , may be 100M at the most . How many billion shares have been sold since . So the extra 50M would have made zero difference in current status.
You think $NWBO is a small bios? Are you serious?
slave1, can you tell me where we know that:
32. NWBO is preparing a rolling BLA — an FDA-accepted approach for biologics.
It's a hobby, he posts during commercials, like I do.
You think $NWBO is a small bios? Are you serious? Had $NWBO been a small company, would you have been spending ten years of your life on it?
It is a giant company in terms of how revolutionary is the technology owned by the company. It is a company which will marginalize all those BPs and make them fight for their survival. See the following figures which have all the targets that three BPs load on their precision medicine to treat different types of cancers? It happens that some of those targets (mutated genes overexpressed on cancer cells) also exists in brain tumors. Can DCVax-L take care of all the cancers that these three BPs are trying to treat? Now you should know why UK had the expansion of IFR to cover all solid tumor types.
Have you read the comments by Martin Makary and Vinay Prasad? Do you think they know how to evaluate the efficacy of immunotherapy? Here on this board people talks about p3 trial all the time. IMO, the most important part that should be emphasized all the time is over 33% of pseudoprogression which means there were significant t-cell infiltration into the coldest tumor sites. Do you know how hard to get t-cells infiltrate into cold tumor sites? It is very, very hard. Once t-cells loaded with target information are present in tumor sites, all those inhibitors can engage with t-cells by unmasking the proteins that prevent t-cells from eliminating cancer cells. Does this fit the concept of a "plausible mechanism of action" proposed by Martin Makary?
I count on this two gentlemen to cut the red tape and do what they say. Do you think they will let down the $NWBO longs and cancer patients suffering from rare cancers? I BET THEY WILL NOT!
FDA’s Conditional Approval Plan Would Unleash Biotech Innovation
https://www.forbes.com/sites/greglicholai/2025/05/05/fdas-conditional-approval-plan-would-unleash-biotech-innovation/
FDA Commissioner Marty Makary has announced plans to create a new pathway for drugs targeting rare conditions.
The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines to patients before they clear the traditional efficacy bar for authorization, Prasad said Tuesday.
Vaccine-Induced Intratumoral Lymphoid Aggregates Correlate with Survival Following Treatment with a Neoadjuvant and Adjuvant Vaccine in Patients with Resectable Pancreatic Adenocarcinoma Available to Purchase
https://aacrjournals.org/clincancerres/article-abstract/27/5/1278/83987/Vaccine-Induced-Intratumoral-Lymphoid-Aggregates
Immunotherapy is currently ineffective for nearly all pancreatic ductal adenocarcinomas (PDAC), largely due to its tumor microenvironment (TME) that lacks antigen-experienced T effector cells (Teff). Vaccine-based immunotherapies are known to activate antigen-specific Teffs in the peripheral blood. To evaluate the effect of vaccine therapy on the PDAC TME, we designed a neoadjuvant and adjuvant clinical trial of an irradiated, GM-CSF-secreting, allogeneic PDAC vaccine (GVAX).
Abstract 3102A: Analysis of spatial relationships between infiltrating immune cells within the tumor microenvironment following combinatorial immunotherapy
https://aacrjournals.org/cancerres/article/79/13_Supplement/3102A/635085
Pembrolizumab for all
https://link.springer.com/article/10.1007/s00432-022-04412-4
Neoadjuvant followed by adjuvant pembrolizumab in melanoma: time biases in the data analysis of the SWOG S1801 tria
https://www.sciencedirect.com/science/article/pii/S193652332400086X
Pembrolizumab for Non–Muscle-Invasive Bladder Cancer—A Costly Therapy in Search of Evidence
https://jamanetwork.com/journals/jamaoncology/article-abstract/2774444
Current Landscape of Immunotherapy Trials Involving the Programmed Cell Death Protein 1/Programmed Death-Ligand 1 Axis in Intrathoracic Tumors
https://www.sciencedirect.com/science/article/pii/S2666364321000084
Gary, That's a very interesting point. Phase 4 confirmation trial provides a real-world perspective of how a drug performs without the preset limitations in a clinical trial, across a diverse set of patient conditions.
manibiotech,
I get the wanting to know thing and transparency but you seem to think that supporting a breakthrough tech for so long instead of so called longs knowing the time cost and creating much more dilution from selling and trying to buy back cheap would have been a good thing. All the extra selling would have likely driven the company to bankruptcy or at least to way more dilution so how would that be a good thing for patients or investors? Best wishes.
As of today things are so different at the FDA I really have no idea what to expect from them. To my knowledge Dr. Padzur is still in charge of Oncology, so we'll be dealing with him, but I have no idea what he's being told from above. He's good at speaking about making dynamic changes, but I can't say I've seen huge differences during all his years in charge there.
I hope the FDA will make trials cheaper and faster to run, make approvals easier, but follow each approval with Phase 4's to be certain that new products are safe and effective. In the past, drugmakers have had flaws covered up by settling claims against them by paying, with confidentiality agreements, so problems stayed hidden for years. By having Phase 4's after every approval, the drug developer gets paid, however, if there are problems, they'd become apparent in the Phase 4's where results from every use is reported.
Of course, the lawyers won't like such an arrangement. Without confidentiality agreements hiding poor outcomes they could be losing a lot of business, but it would be good for the industry.
Gary
Eagle, Thanks again. Andrew Caravello, DO post is very illuminating.
Worth a sit-down read. This is possibly what the Dr. Bosch NYAS lecture will be regarding.
Basically, NWBO is working with Roswell Park collaborators and are generating a supercharged DCVax, aDC1, that is part of what is now a DCVax "broader stack":
1. DCVax, the patient-specific tumor lysate vaccine
2. Supercharge with aDC1s
- To transition DC into an inflammatory, IL-12 producing, Th1-polarizing one, an aDC1
- Generated by using specific cytokine cocktails (IFN gamma, TNF alpha, IL-1 beta, IL-6, PGE2)
3. Prime the tumor microenvironment
- Hiltonol, an adjuvant to trigger systemic immune response
- Celecoxib, likely to reduce immunosuppression
- Interferon, can promote immune cell activation
- Caveolae Delivery, use antigen discovery via DCVax to identify delivery pathways within the tumor
Note: Caveolae delivery (cellular internal pathway) is particularly interesting. Many drugs struggle to reach all parts of a solid tumor. If DCVax reveals where specific antigens persist in tumor vasculature and integrates DC delivery into that vasculature, then that equates to highly personalized and precise drug targeting.
Amazing.
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Moderators skitahoe Steady_T sentiment_stocks CaptainObvious Doc logic JerryCampbell |
“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
~ Winston Churchill
Stylized Dendritic Cell featured on NWBO board since 2015
- Dr. Linda Liau, PhD, MBA, Professor and Chair, Department of Neurosurgery, David Geffen School of Medicine at UCLA
Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind)
UK (MHRA): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
DE (Germany - PEI): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III
Dendritic Cell Vaccine for Patients with Brain Tumors (NCT01204684) - Phase II - at UCLA - Randomized (Open Label) testing DCVaccine with Resiquimod and DC Vaccination with Adjuvant polyICLC
Pembrolizumab and a Vaccine (ATL-DC) for the treatment of Surgically Accessible Recurrent Glioblastoma - Phase 1 (NCT04201873)
Dendritic Cell-Autologous Lung Tumor Vaccine (DCVax-L) and Nivolumab in Treating Patients with Recurrent Glioblastoma - Phase 2 (NCT03014804)
Dendritic Cell Therapy for Brain Metastases From Breast or Lung Cancer (NCT0368765) - Phase 1 - Collaborator: Mayo Clinic
Announcement of DCVax-L and Anti-PD-1 Monoclonal Antibody (Pembrolizumab) for Patients with Liver Metastases of Primary Colorectal Carcinoma Phase 2 Trial - November 17, 2016 - University Medical Center (UMC) of the Johannes Gutenberg University of Mainz
Cognate Bioservices - Owned by Charles River Labs
Website
Company Contact Info
Investor Relations:
Les Goldman (Company) (202) 841-7909 lgoldman@nwbio.com
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Company Headquarters
4800 Montgomery Lane, Suite 800, Bethesda, MD 20814 (240) 497-9024
NW Bio is developing cancer vaccines designed to treat a broad range of solid tumor cancers more effectively than current treatments, and without the side effects of chemotherapy drugs. NW Bio’s proprietary manufacturing technology enables them to produce its personalized vaccine in an efficient, cost-effective manner. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines.
Their lead product, DCVax-L, is currently in a 331-patient Phase III trial for patients with newly diagnosed Glioblastoma multiforme (GBM), the most aggressive and lethal brain cancer. This trial is currently underway at 69 locations thoughout the United States, Germany and the United Kingdom. NW Bio has also conducted a Phase I/II trial with DCVax-L for late stage ovarian cancer together with the University of Pennsylvania.
Their second product, DCVax-Direct, is currently in a 60-patient Phase I/II trial for direct injection into all types of inoperable solid tumor cancers, with trials currently being conducted at both MD Anderson Cancer Center in Texas, as well as Orlando Health in Florida.
They previously received clearance from the FDA for a 612-patient Phase III trial with its third product, DCVax-Prostate, for late stage prostate cancer.
DCVAX Survival Stories & Testimonials
Alice - Metastic Merkel Cell patient from Florida - ASCO 2018
Brad Silver - GBM patient from Huntington Beach, California - ASCO 2018
Sarah Rigby - GBM patient from Hong Kong - ASCO 2018
Kristyn Power - daughter of GBM patient from Canada - ASCO 2018
Kat Charles - GBM patients from UK - ASCO 2018 - as related by her husband Jason (Kat's Cure)
Prospective patients may contact NW Bio at patients@nwbio.com
UCLA Jamil Newirth DCVax-Patient Video - 2015
Allan Butler Video - National Geographic Vice President - DCVax-Direct patient from Phase 1 Trial with Pancreatic Cancer
NWBO - Patients Sunday Dennis and Jami Newirth - Enrolled at UCLA - Vimeo, Uploaded approx. May 2015
NWBO - Vaccine Helps Keep Brain Cancer Patient Alive (Jennifer Sugioka) - NBC Channel 4, Southern California, February 24, 2015
NWBO - National Geographic's Allan Butler Stage IV Pancreatic Patient using DCVax-Direct at MD Anderson
NWBO GBM Brain Cancer Survival Story of Mark Pace
Presentations
UCLA Agreements
Prostrate
DCVax-Phase II
DCVax-Booster
Upcoming Events
Videos
Linda M. Liau, MD, PhD, MBA - April 24, 2019 at University of Washington, Neurosciences Institute
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