NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

Non diluted loan Northwest Biotherapeutics Announces $15 Million Financing. Tweet by a major holder of NWBO, "
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Northwest Biotherapeutics Announces $15 Million Financing​

Northwest Biotherapeutics Logo. (PRNewsFoto/Northwest Biotherapeutics, Inc.)
News provided by
Northwest Biotherapeutics
Nov 29, 2021, 10:38 ET

​


BETHESDA, Md., Nov. 29, 2021 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced the closing of a $15 million financing on November 22, 2021, which brought the Company's cash reserves above $20 million.
The Company plans to use the funding to help accelerate its activities related to its brain cancer program. The financing is in the form of a 22-month loan which requires no payments for 8 months, and then provides for a subsequent 14-month amortization period. The loan has a provision for prepayment, an annualized interest rate of 8% and OID of 10%. Upon announcement of the top line data ("TLD") from the Company's Phase III clinical trial of DCVax®-L for Glioblastoma brain cancer, the lender will have a then-springing right to exchange the outstanding balance of the loan for common shares priced at the price of the first private placement transaction following TLD less a 12% discount, and to purchase another 50% of that number of shares at the same price. This then-springing right expires 14 days after that post-TLD private placement.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." This Phase III trial reached data lock and the Company is actively continuing to move toward announcement of top line data. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Dave Innes Les Goldman
804-513-4758 dinnes@nwbio.com 240-234-0059 lgoldman@nwbio.com
SOURCE Northwest Biotherapeutics
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added today in the range from 0.754 all the way to 0.745. Cannot believe the market behaves this way. Looking for long term is the only game for this one.
 
Nothing has fundamentally changed but moved closer to TLD/publication news. What attached below is analysis of an investors who went through once again what could be a near certainly worse scenario regarding TLD/publication, market reaction (courtesy of Umibe 5690, a lawyer by trade):
"
I think that you are wrong. The fact of the matter is that LP and LG are not making decisions in a vacuum. They are doing so on important strategic issues on a collaborative consensus basis with all the advisors they have.

LP is being counseled by extremely experienced and top advisors who can afford to be objective about the direction the company is taking.

For example, I can guarantee you that their outside counsel including Gibson Dunn for legal and regulatory matters are extremely experienced and have extensive networks. LP is not ignoring their advice on regulatory, legal and business matters, you can be sure. Firms of that caliber are very conservative and careful and their reputation is of the utmost importance. They don’t need NWBO’s business and if there is even a hint of impropriety they will investigate and withdraw if they have to. There is no question that she is collaborating with her SAB, independent consultants, Principal investigators and other experts where she is paying not insignificant sums for their input and advice. She would be foolish to make decisions in a vacuum. Further, LP and LG are not inexperienced themselves. So it is the ENTIRE TEAM that is contributing to the decisions made and not just LP and LG. Further, they are in possession of a lot more information than ordinary shareholders and denizens of MBs like iHub.

I am certain that their outside counsel has recommended that NWBO engage in silence rather than to give essentially meaningless updates on timelines and progress where at least some of it is completely out of their control. What is meaningful is TLD and much more importantly RA approvals. Short of that(pun intended) other information revelations will not move or sustain the needle much if at all. Until they are ready to reveal important information, it is better to be silent.

Naysayers FUD that management is hiding something, that if the trial were a remarkable success, the data would speak for itself and it is not necessary to tie TLD to a journal publication. And if the data were so remarkable, a top tier journal would have accepted an article by now or at least it would have been written and submitted for peer review and this announced by now in conjunction with TLD.

The fact of the matter is that it is not quite that simple. And NWBO is playing to three separate audiences: RAs, the medical community and Wall Street wrt MC. It would not be a surprise at all if NWBO missed the original primary PFS and secondary OS endpoints. In that respect, the naysayers could well claim that the trial failed. Within that context, LG has insisted in conversations with me and others I know that the “trial has not failed”. Even DI has indicated in certain conversations with MBers that if the trial had failed they would have had to reveal this and certainly by now.

What I believe is not adequately remembered or understood is that this is an adaptive trial. Further, the trial concerns an orphan disease. What the former means is that the trial can be modified within the context of advancing knowledge and techniques not known or reasonably foreseen at the time of original trial design provided that the trial remains blinded. This resulted in the modified SAP with the reordered and added end points. The orphan disease designation allows for and encourages the trial sponsor to engage and have easy access to the FDA for guidance. There can be little doubt that the resulting SAP was developed in accordance with FDA guidance. In fact, the guidelines developed by the FDA were drafted in connection with at least some input from these discussions and back and forth with the FDA. Support for these guidelines from members of the FDA were mentioned in recent Lancet publications. IMO, it is reasonably certain that the FDA at least implicitly if not tacitly agreed with the modified SAP and resulting endpoints especially considering the adoption of these endpoints by European RA counterparts. I think it is reasonable to conclude that the 4 involved RAs are in agreement with these endpoints regardless of whether the US clinical trials org was updated or not. Hence it is a true statement that even though the original endpoints may not have been achieved that this trial has not necessarily failed given the modified SAP. Admittedly, this does not mean that the trial absolutely succeeded but may be in a “grey area”. Accordingly, NWBO has not directly confirmed that the trial has been a success but rather nuanced that it has not failed at least wrt to the modified end points even though it may have failed to achieve the original endpoints.

I am reasonably certain that NWBO has succeeded in meeting the current OS endpoint as compared to synthetic external controls by a significant margin. In addition, NWBO has highly likely achieved the 6th endpoint(secondary) with respect to immune agent infiltration. At a minimum, NWBO has almost certainly achieved to meet two endpoints. In addition, NWBO will also be able to demonstrate a long and robust tail. All especially wrt the new definition of GBM. With the achievement of the foregoing, it is a reasonable certainty that at least the MHRA will relatively expeditiously extend marketing approval. This will get the ball rolling with the other RAs. I believe a precursor to MHRA marketing approval will be its preceding GMP approval for Sawston. The MHRA would not waste its time giving GMP approval for a “failed trial product.” Accordingly, marketing approval by the MHRA is very likely to follow suit. I think it likely that the MHRA(as well as the other RAs) has been given a peak at the results. The foregoing as a minimum and worst case scenario is almost certainly sufficient enough for approvals from all 4 RAs including the FDA which will not risk being an odd man out especially given its guidelines and FDA staff endorsements in recent articles. There is just too much pressure upon the FDA given almost certain approval by the MHRA, the Biden administration’s stance on cancer and familiarity especially wrt glioblastoma and the need for an alternative therapy that is reasonably efficacious and SAFE for patients afflicted by this disease. Further, the results of this trial will compare extremely favorably with Optune as we have seen with the blinded results comparisons and the divergence seen as one goes out beyond two years which is where Optune actual data stops.

As I opined hereinabove, I would not be surprised if NWBO failed to achieve the original primary and secondary endpoints, unadjudicated PFS and OS Tx as compared to control which includes crossover. I think these endpoints were reordered and included under FDA guidance with a recognition that these endpoints should not be ignored and swept under the rug so to speak even though there may be good reasons for possible failure given confoundment of pseudo progression which was not well understood and crossover which if not required by the FDA was at least tacitly agreed by them in recognition of the difficulty in attracting trial candidates as well as ethical considerations. In addition, confirmed PFS(cPFS) may not be statistically sufficient in that even though there may be some or even significant pseudo progression found, it is not possible to accurately ascertain how much longer, if at all, these pseudo progressors may have gone until an actual disease progression finally occurred.

In addition, while not a certainty, I believe that there is better than a 50% chance that the cross over arm as compared to external rGBM SOC could be statistically significant. This would be an extremely remarkable achievement and perhaps even more significant than achieving the primary OS end point for nGBM. This was not a trial geared for rGBM. There were an insignificant number of second resections where mutated antigens were not covered and provided a pathway for more virulent recurrence. However, a significant proportion of these recurrent tumors morph into the very aggressive mesenchymal type which is the sweet spot for DCVAX L. This would be a significant breakthrough for rGBM therapy significantly increasing efficacy in recurrence with safety. If the three foregoing end points were achieved, this would be a grand slam home run which even market naysayers would be hard pressed to refute. This would certainly call for expedited RA approvals. The original OS secondary endpoint would probably not demonstrate a statistically significant separation meaning that even delayed administration of the vaccine is efficacious and particularly in connection with aggressive recurrence. Accordingly, curve separation would be evident in this first secondary end point achievement.

Non achievement of the original PFS endpoint may certainly be evident due to confoundment of pseudo progression. Thus, PFS in this case may not be a good correlative or surrogate for the gold standard OS. It may be that there was no significant improvement in PFS over control but that does not necessarily mean that the vaccine is not effective with respect to PFS. It may be that although there is little to no difference between control and treatment eventing, never the less, DCVAX L slows the progression rate such that OS is prolonged and this might be demonstrated by the improved interval between PFS eventing and succeeding OS eventing. I specifically addressed this possibility with LG and he said that this plus other factors would be considered depending upon the results. So this possibility appears to be on the investigative table.

Hence, with very careful and detailed explanations backed by the data, what might be perceived by the market at first as overall lackluster results with non-achievement of original endpoints including adjudicated PFS, would be eventually reconsidered by the market as significant and remarkable results especially if the rGBM endpoint is met. Certainly the regulatory and medical communities would be quick to perceive a successful trial even if the worst case scenario mentioned above should occur. Market recognition would inevitably follow.

Accordingly, a peer reviewed top tier journal is required in order to provide explanations for what might be perceived at first blush as a mixed bag result, especially by the marketplace. After all, it will be very important for NWBO to gain market recognition for needed financing, without more toxic dilution, through a significant rise in the MC/SP. Therefore, it is absolutely essential that NWBO/PIs provide a carefully explained and supported publication through a high impact journal. That is a key part of their strategy and may be a reason for the length of time thus far taken for journal acceptance and publication. They need to get it right the first time. Such explanations, as suggested above as examples, will have important validation if published in a top tier journal. But they need to be carefully explained and wordsmithed and this takes time and input/reviewed by a number of interested parties.

My point in explaining all of the above is that this is overall a complex process not given to simple explanations that the data speaks for itself. Unfortunately in such a case, the numbers/ graphs are not the whole story. LP and LG are not making decisions in a vacuum considering all these complex parts and how they come together. It is a whole team including NWBO management and their entire hierarchy of consultants and advisors possessing information that we as retail shareholders are not privy to in making collaborative decisions. Even the FDA has provided guidance and input through the orphan status protocol. If one claims that LP does not know what she is doing, then I submit that it is not just her but her whole team. This is highly unlikely.

In the past, I was highly critical of management but I was certainly premature if not entirely wrong in my judgement. These are very smart and experienced teams including LP and LG. Read their backgrounds. Don’t know what they are doing? Not by a long shot in my book.

I strongly believe that the results will be understood by all constituencies as remarkable including the RAs, medical community and patients and ultimately, Wall Street. “Incompetent management” will have a lot to do with this success. JMHO.
"
 
short-term: Sawston manufacturing license, not I care though.
 
最后编辑:
現在已經不敢奢求年底前看到TLD了
 
看来你已经是NWBO投资老人了。就等吧， 如果坚信三期临床结果好到能得到批准，要么等， 要么趁现在股价低加些。
 
www.prnewswire.com

Northwest Biotherapeutics Announces MHRA Approval Of License for GMP Manufacturing At Sawston, UK Facility

/PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor...
www.prnewswire.com www.prnewswire.com

Northwest Biotherapeutics Announces MHRA Approval Of License for GMP Manufacturing At Sawston, UK Facility​

Northwest Biotherapeutics Logo. (PRNewsFoto/Northwest Biotherapeutics, Inc.)
News provided by
Northwest Biotherapeutics
Dec 21, 2021, 09:24 ET

Share this article​


BETHESDA, Md., Dec. 21, 2021 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that approval has been received from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at its Sawston, UK facility.
The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP facility in London. The license also permits the import and GMP manufacture of other cell therapy products under the UK's supply of unlicensed medicinal products ('Specials') regime and for clinical trials under the Investigational Medicinal Products (IMP) Programme.
The Company is developing the Sawston facility in phases, both to optimize the timing of capital requirements and to enable each phase to be state of the art when developed, as manufacturing technologies are advancing significantly in the field of cell therapies. To date, the Company has developed Phase 1A of the facility, comprising approximately 4,400 square feet of the overall 88,345 square feet. The Company anticipates that Phase 1A alone will be able to manufacture DCVax-L products for 45-50 patients per month, or 450-500 patients per year – a significant increase from the current manufacturing capacity of four to six patients per month which, to date, has been taking place in a GMP clean room facility in London, UK.
This MHRA license is a culmination of intensive preparations that have been underway for much of 2021. The process included an extensive application process, a week-long inspection of all aspects of the physical facility, its construction and equipment, all aspects of the facility's operations, including all operating systems, flow of materials and activities, sterility, quality control, staff and other factors, and all of the regulatory documentation, including standard operating procedures (SOPs) for the facility and for the product, batch manufacturing records, data from practice manufacturing runs and other required documents.
This MHRA license follows the license approval by the UK's Human Tissue Authority (HTA) in October. That license covers the collection, processing and storage of human tissue and cells for medical purposes, including cell therapies such as DCVax-L. The preparatory work and applications for the MHRA and HTA licenses have been carried out by Advent Bioservices, NWBio's UK entity contract manufacturer, operator, and license holder.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." This Phase III trial reached data lock and the Company is actively continuing to move toward announcement of top line data. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will demonstrate safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
SOURCE Northwest Biotherapeutics
 
www.heraldtribune.com

DEDUCED RECKONING: Northwest Biotherapeutics receives license for Sawston UK plant

Just before Christmas, NWBO received approval from the UK’s MHRA licensing its Sawston UK plant to continue production for compassionate use.
www.heraldtribune.com

DEDUCED RECKONING: Northwest Biotherapeutics receives license for Sawston UK plant​

Joan Lappin
I last published a column on NWBO on Dec. 24, 2020, when the stock was $1.40. The stock traded up 50% to $2.15 in May before the entire biotech sector took a nosedive in the second half. I have received letters from readers asking about NWBO as it was swept down with the group.

For comparison: Cathie Wood’s ARKG Genomics ETF peaked on Feb. 10 at 115 and is now trading at 62, a decline of 46%. XBI, the S&P Biotech Select ETF, has dropped 34% from 174 in February to 115.

Just before Christmas, NWBO received approval from the UK’s MHRA licensing its Sawston UK plant to continue production for compassionate use (referred to as “specials” in the UK) for its personalized vaccine for glioblastoma, DC VAX-L. Prior to its approval, individuals may now apply in the UK to use the drug. The Sawston license is for a clean room environment using the same ongoing batch process that is monitored by a trained technician, similar to its lower volume facility in London for such patients. In August 2020, NWBO acquired Flaskworks from Corning Glass seeing the potential to eventually automate its production of personalized vaccines. In the Flaskworks system, the vaccine material is processed in a sealed container system which lends itself to replicating procedures that optimize purity and reduce the risk of contamination. This could ultimately lead to an automated assembly line process as the system is refined. Note that both the Sawston plant and the Flaskworks technologies are directly owned by NWBO.

NWBO announced it had locked the data from its 15-year Phase 3 trial of DCVAX -L in glioblastoma in October 2020. We still await the results. The average patient lives only 15-18 months after surgical resection of their tumor, radiation and dosing with Merck’s Temodar, the standard of care. In those 15 years since Temodar was approved, over 400 trials in glioblastoma have failed to improve that dreadful outlook. DCVAX-L is non-toxic with a very positive safety profile. It doesn’t help all patients but some of those who survive have gone on to live cancer free for more than a decade.

Most cancer treatments are prohibitively expensive. As for the expected cost of DCVAX-L, judging from talking with people who have previously undergone treatment in the UK, I believe t it is possible that DCVAX-L might be priced at half the cost of the approved immune therapies offered by Big Pharma.

NWBO now has more than 200 process patents in countries around the globe. This year Japan, Israel, Russia, the U.S., the U.K. and Canada have granted additional patents. The Flaskworks patent portfolio has the potential to be licensed to others in the future providing a possible future income stream. As an example in another sector, QUALCOMM has both produced its own chips for cellular technology through the years and enjoyed a very rich stream of licensing royalties for its patents. In 2019, Apple is estimated to have paid QCOM between $5 billion and 6 billion for infringing QCOM’s telecom patents. It agreed to pay $8-9 per phone going forward.

It’s been reported that release of the Top Line Data (TLD) in a peer reviewed medical journal could be a likely next step. This could be followed by: A conference presentation or several to explain the findings; filing of the drug application, likely first in the U.K.; uplisting of the stock from the pink sheets back to a major exchange.

Until DCVAX is approved, this stock is not without risk. We continue to own NWBO.

Joan Lappin CFA has been called an “investment guru” by Business Week and a “top manager” by the Wall Street Journal. The Sarasota resident founded Gramercy Capital Management, a registered investment adviser, in 1986. Email her at JLappincfa@gmail.com. Follow her on twitter: @joanlappin. Her past columns appear at heraldtribune.com/business/columns.
 
www.cancerdefeated.com

A Vaccine for Cancer

www.cancerdefeated.com

A Vaccine for Cancer​


588edd94a89acff9ba8c7ae4b3e94e31

By Lee Euler / January 2, 2022


dendritic-cell.jpg

Vaccines have been a hot topic as we make our way through the coronavirus pandemic. But not all vaccines target viruses and the like. There’s also a vaccine for cancer. Best of all, it doesn’t employ drugs, just your own immune system.
It’s called Dendritic Cell Therapy, or DC therapy, though most people refer to it as the Dendritic Cell vaccine.
In a nutshell, it’s an approach to cancer treatment that uses your body’s own immune system to fight cancer. There have even been some reports of complete turnarounds, including in some late-stage cancer patients — essentially hopeless cases — who didn’t respond to other therapies.
But that’s not all.
Not only is DC therapy a promising treatment for advanced cancer, it’s also showing promise as a tool to prevent cancer in the first place.
Dendritic cells: What they are and what they do ​
Dendritic cells are a type of immune cell found in mammals. Their role is to recognize and attack foreign invaders. They function as a messenger cell or information carrier that helps activate a type of immune system cell called T-cells, giving the T-cells the capacity to be aware of threats to the body. Once alerted to danger, the killer T-cells circulate throughout the body to destroy the foreign invaders.
Dendritic cells are present in the skin and other tissues that have contact with the external environment, such as the lining of the nose, lungs, and stomach. They exist in an immature state in the blood. But although they’re extremely powerful, dendritic cells don’t occur in big numbers in the body. At any rate, there aren’t enough of them to prompt a significant immune response to cancer.
Dendritic Cell Therapy changes that. It boosts the number of dendritic cells in the body so there are more messengers to activate killer T-cells to attack invading cancer cells.
“Most wanted” posters for the immune system ​
Cancer treatment vaccines are designed to activate B-cells and killer T-cells. They alert those cells to the foreign invader (cancer). Vaccines, which are usually administered by injection, do this by introducing antigens into your body.
An antigen is an agent that provokes an immune system response. It’s basically something that “isn’t you” and may be harmful. An antigen may be a protein, or some other type of molecule found either inside or on the surface of a cell.
Dendritic cells are antigen-presenting cells. They basically serve as messengers between the innate immune system (your body’s first line of defense) and the adaptive immune system, which remembers pathogens (i.e. germs) that it has seen before, and mounts ever stronger attacks against them.
This part of the immune system is called “adaptive” because it’s the body’s system for preparing for future challenges, not merely for the antigens it’s seeing now.
Imagine your home is invaded by a burglar, but you’re able to scare him off. Then you buy a security system for your home, so you’re better prepared the next time than you were the first time. That’s an adaptive response.
Your immune system likewise learns from its encounters with invaders and prepares for the next round. It does this by “remembering” how to tell an invader from a harmless cell. That way it can pick the invader out in a crowd and head right for it.
What’s the role of dendritic cells in all this? One researcher compared dendritic cells to “most wanted” posters for the immune system, since they tell the killer T-cells exactly which antigens to go after.
Think again of the invader of your home. Imagine you were able to get his picture. Or maybe you already had a security system that captured his image on video. You circulate his picture to the neighbors, so next time he’s seen in the neighborhood, he’s reported immediately. He never even gets near your house.
Now that’s a really adaptive response!
A glimpse into how the vaccine works ​
To make the dendritic cell vaccine, researchers take a patient’s dendritic cells and expose them to immune cell stimulants. This prompts dendritic cell development. After that, the dendritic cells are exposed to antigens from the patient’s cancer cells. Think of this as showing all your neighbors a picture of the criminal, so they’ll know him if they see him.
Then, the combination of dendritic cells and antigens is injected back into the patient. From there, the dendritic cells work to program the T-cells, so they know exactly what to attack.
So far, this approach seems to work well for most patients, except those with depressed immune systems. Unfortunately, chemotherapy and radiation depress the immune system.
The Dendritic Cell Therapy may also be inappropriate for patients who are pregnant, who suffer from active autoimmune disease (such as rheumatoid arthritis), or who have recently received a blood transfusion.
This works on a growing list of cancers… ​
This treatment has some of the biggest players in conventional medicine nodding their heads.
For example, the former Vice President of Research at the American Medical Association, Dr. Harmon Eyre, once said of Dendritic Cell Therapy, “Patients’ responses are far out of proportion to anything that any current therapy could do.”
Researchers feel immunotherapy with dendritic cells shows a lot of promise even for some of the toughest cancers, such as advanced prostate cancer. Several trials have shown promise in extending survival for prostate cancer patients.
Melanoma and kidney cancer appear to respond best, but the vaccine has also shown documented benefit in B-cell lymphoma, myeloma, colon cancer, ovarian cancer, breast cancer, and renal cell cancer, among others.
There have been more than 20 trials examining the effectiveness of Dendritic Cell Therapy on everything from ovarian and lung cancer to Stage IV Melanoma. The results suggest that the best time to attempt Dendritic Cell Therapy appears to be when the disease is stable and the patient isn’t going through chemotherapy or radiation, when a patient is at risk of the disease recurring, or when all other options have been exhausted.
The future for immunotherapy is bright ​
Dendritic Cell Therapy is FDA approved and some experts predict that it will become commonly used as a stand-alone therapy, at least in certain patients. It’s also likely to be used in combination with drugs that target suppressor pathways in patients with metastatic cancer (i.e. cancer that has spread beyond its original location).
I think the outlook for immunotherapy is very exciting. It’s nice to know researchers are at last tapping the true power of the body’s natural immune system.
One researcher even said these vaccines could possibly lead to the complete prevention of cancer. That’s a bright future I’m looking forward to.
Best regards,
lee_euler_sig.jpg

Lee Euler,
Publisher
 
Tax selling buying back? Yes, but that's not the point. Instead, it's a new dynamic of 2022 which alone may manifest new higher in price every week/day, let alone the fundamental 10X factors such as TLD/Publication, partnership/buyout potentials, commercial success of UK Special, & many other positive news coming out of hibernation!

One thing is certain that 2022 will be a different year in the land of NWBO.
 
Jan 18th GBM drug development summit,
現在就只能期待TLD 可以在會前發表。
 
平常心就好。 现存脑癌标准疗法鼻祖，FDA批准电磁疗法试验主任Roger Stupp, M.D去年公开承认（一反他过去的一贯主张）：标准疗法主要成份化疗药物Temozolomide对大多数病人无益；电磁疗法Optune Device宣扬的长期存活率比如五年13%根本没有根据。

在看似平静的海面下，似乎一个新的标准疗法正在成形。

希望是好事多磨。
 
A good day for nwbo as the Wall Street is swallowed in bloodbath today. Is it the start of good news trickling or waterfalling as we have expected for a long time?

Hopefully it's not just because of buybacks of those who sold for tax purpose last Dec.
 
最后编辑:
Normally I am not an investor who constantly looks for breadcrumb or tea leaf. The day of day trading, swing trading, shorting, constantly in and out with 25% profit/loss has long gone. this weekend there is some substantial DD worthy of notice:

Roger Stupp who is the funding father of Stupp Protocal, a standard used to treat brain cancer patients for decades and an opponent to NWBio's DCVax-L's positive outcome in treating brain cancer has been found onboard as advisor for NWBio, a week just NWBio announced data lock last October.

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