Stock of Interest (NWBO): Potentially Lose $0.5 or Gain $30 or More in Near Future[Finally Phase 3 Data Locked as of 5 Otc 2020, Results Soon!!!]

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如果你相信未来的癌症治疗应该是利用(调动)每个人自己独特的天然免疫力和自己独特的癌细胞抗原去消灭自身独特的癌细胞,而非现有的“三光”疗法:杀光(化疗),烧光(放疗),和抢光(各种民间神医),那么DCVax治疗方法或许值得你进一步深入的研究。

It's about time for data lock.
 
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Two rhetoric comment pieces from ihub:

"

Dan88 Thursday, 06/25/20 10:02:47 AM
Re: Basin Street Blues post# 291674
plusonecoin_v.svg
1.000
Post # of 292056


New found alliance? LOL we knew it century ago.

At $0.37 per share, and a roughly $260 million MC today. Is this not cheap enough?

Now looking forward

Data lock by end of next week

Topline data by end of next month

By a margin, you are free to move around these goal posts some days further. Regardless, there will be a rude awakening for a lot of heads when all are done soon.

The blinded data just need to be confirmed to be equally good if not better. Then

FDA has no way but to usher in a new age of how cancers will be treated with a new generation, paradigm shift immunotherapeutic cancer vaccines spearheaded by Northwest Bio's DCvax platform.

There is a risk of course, but it is worthy of taking. Many still have the pipe dream to get in cheap when things turn out to be what expected with regard to trial data.

At this point, the usual fearmongers like dilution, financing, and the like don't work any more."

And

"
iwasadiver
Member Level
Thursday, 06/25/20 02:49:44 PM
Re: spidaman post# 291619
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0.150
Post # of 292057


I don’t feel it’s going to be a buyout for a while. Maybe a partnership on some development. But I think BMY sees beyond PD-1 and may be willing to partner to get to the next bigger thing that NWBO has the recipe for. Either way I see, in the end, something beyond $50-75/share. I know that people are rolling their eyes at this but I’m looking 2-4 years from now. I think we’ll settle in the $20-30/share range in the next year, after initial approvals in the UK and then the US. The generation of revenue this quarter is only the beginning of what’s going to occur from here on and as Sawston expands as we wait for approvals. That number is going to increase significantly which keeps adding to the legitimacy of NWBO as we cross $3-8/share by fall/winter (I think a spike after TLD will get over bought and settle back) after 2 more quarters of earnings and TLD, new announcements before/during November, etc. This will pick up institutional investment which has been on the sidelines and we’ll start rolling as a real company that then will have regular PR firms, and the ability to hire proper numbers of people to do all the various work 3 people are now doing. The slow roll has begun in my opinion and has been shown by the steady share price rise once the initial reaction occurred. It’s just my thoughts, but why I’m still buying."
 

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Snail steps! Nonetheless a step is a step closer to topline data.


Northwest Biotherapeutics Announces Completion of Phase 3 Trial Sites' Databases

News provided by
Northwest Biotherapeutics
Jul 24, 2020, 09:31 ET


BETHESDA, Md., July 24, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the data collection from all of the clinical trial sites for the Company's Phase 3 trial of DCVax®-L for Glioblastoma brain cancer (the "Trial") has been completed and all of the sites have signed off on the locking of their data.


As noted in the Company's prior reports, in order to reach overall data lock for the Trial, each site's data must go through final collection, review, checking for queries, resolution of queries preparatory steps for locking the site and finally personal sign-off by the lead investigator at each site for that site's data. For that purpose, the lead investigator must undergo training on the system, review the site data, personally complete the confirmation and deliver it to the independent contract research organization (CRO) managing the Trial.


Reaching these personal sign-offs by each lead investigator at each of the Trial sites has been a key focus of activity towards data lock for the last couple of months, especially during June and July. At the time of the Company's last report near the end of June, about 30 Trial sites were in varying stages of progress towards sign-off, and about half a dozen Trial sites had not yet completed the preparatory steps necessary to begin the process towards such sign-off.


All of the Trial sites are now finished. The independent CRO has obtained all of the investigator sign-offs for their site's data lock. The sites' data includes all of the clinical data gathered in the Case Report Forms throughout the Trial, and now sit in a signed off, locked position with the CRO.


These datasets from each of the Trial sites (hospitals) are the largest component of the overall dataset for the Trial and contain most of the data. The remaining information for the overall Trial dataset includes some analyses from specialized service providers who are separate from the Trial site hospitals. Such analyses include, for example, genetic profiles such as IDH mutations. For some of these analyses, it has been necessary to go back and obtain additional material due to the age of the samples. For other analyses, it has been necessary to have the analyses done by two separate experts as a cross-check.


This process continues to be impacted by the effects of COVID-19, especially with the resurgence of COVID cases in many areas. For example, key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. However, the CRO and the Company are working intensively with these vendors on a continuous basis to move as quickly as possible.


The Company currently anticipates that the remaining analyses by these specialty service providers will be completed within the next couple weeks. When this external data joins the now locked data from the Trial sites, the overall Trial dataset will be locked.


Following completion of the Trial data lock, the independent statisticians will be given access to the raw data in the Trial database, and will undertake the calculations and the preparations of the Tables and Listings which provide the Trial results. The Company anticipates that the statisticians' work will take several weeks.


The Company will remain blinded throughout this period and will not become unblinded until the independent statisticians deliver the initial results to the Company.


When the Company receives the initial results, it will review the data and results with its Scientific Advisory Board, the Trial Steering Committee, and other key advisors. During this process, any questions or comments from the experts will be addressed as part of the preparation of the results for public reporting. The Company anticipates that these very important discussions with experts could take several weeks, especially with the significant logistical challenges due to COVID-related restrictions (which may be further increasing as the COVID resurgence grows).


In light of the significant progress reported here, together with the next steps in the process and the operational and logistical challenges, the Company currently anticipates that Trial results will be ready for reporting approximately sometime after Labor Day in the month of September. The Company will be consulting with its Principal Investigator and experts on the appropriate venue and manner of presenting the Trial results.


The Company will also continue to provide progress reports as key milestones are reached.


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." The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and is preparing for 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 enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the 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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NW Bio Announces Completion of Further Data Gathering For Phase III Trial
Northwest Biotherapeutics Logo. (PRNewsFoto/Northwest Biotherapeutics, Inc.)



News provided by
Northwest Biotherapeutics
Aug 19, 2020, 11:23 ET


BETHESDA, Md., Aug. 19, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO)("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the remaining outstanding clinical trial data for the Company's Phase 3 trial of DCVax®-L for Glioblastoma brain cancer as described in the Company's last report on July 24, 2020 has now been completed by the specialty analytics firms. With this data now in hand, final quality control checking and confirmation are under way to enable Data Lock.
This further data involves specialty analytics such as genomic profiling for IDH mutations and certain imaging. The independent CRO managing the trial is now integrating this data into the overall trial database containing the clinical data from the trial sites that was already complete and locked as reported on July 24, 2020, in order to complete the overall trial dataset.
When Data Lock is reached, the independent statisticians will be given access to the unblinded dataset. The Company will remain blinded while the statisticians make the computations, converting the mass of raw data from the trial into formal tables and listings, and survival and progression measures, to report the trial results.
As previously reported, the statisticians' work is estimated to take a couple of weeks. When their computations are completed, the Company will receive the results of those computations and thereby become unblinded. It is anticipated that the Company's Scientific Advisory Board, the Steering Committee of the Trial and other key medical expert advisors will likewise receive the results, and thereby become unblinded as well.
The Company currently continues to anticipate reporting topline trial data in September, and anticipates providing further updates as the process progresses.
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 the 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." The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and is preparing for 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 enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the 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 InnesLes Goldman
804-513-4758 dinnes@nwbio.com240-234-0059 lgoldman@nwbio.com
SOURCE Northwest Biotherapeutics
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Acquisition by NWBO: Northwest Biotherapeutics Acquires Flaskworks

Northwest Biotherapeutics Acquires Flaskworks
Breakthrough Automation Technology For Cell Therapy Products To Enable Scale-Up of Production Volumes and Reduction of Production Costs

News provided by
Northwest Biotherapeutics
Sep 01, 2020, 10:07 ET

BETHESDA, Md., Sept. 1, 2020 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that the Company has acquired Flaskworks, a company that has developed a breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax®.


Flaskworks was previously owned by its technical founders and Corning Incorporated. The technical team from Flaskworks has joined NW Bio as part of the acquisition.


It is anticipated that the Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.


To date, the manufacture of immune cell therapies (including T cell therapies and others) has involved two major challenges. First, the manufacturing processes involve "open" steps in which the product is open to the air in the manufacturing suite. This necessitates extremely expensive "clean room" facilities with specialized infrastructure and specialized operating systems for sterile air and water, and personnel working in sterile lab suits ("space suits"). Second, the manufacturing processes are mostly manual processes – in essence, hand crafted artisan processes by highly skilled technicians working under sterile conditions.


These factors have made the manufacturing of immune cell therapies (such as T cells) very costly, and greatly limited the number of such therapies that can be produced. There simply are not enough of the specialized clean room facilities, not enough highly skilled artisan technicians, and each technician can only produce limited amounts of products.


The Flaskworks system is designed to fundamentally change the manufacturing process from artisan hand work to assembly line-like automation. As such, the Flaskworks system is designed to enable the scale-up to far greater production volumes. Technicians will oversee the automated systems (potentially multiple systems per technician) rather than making the products themselves.


The Flaskworks system is also expected to significantly reduce production costs: turning "open" steps in the manufacturing process into "closed" steps, in which the product is not open to the air in the manufacturing suite, removing the need to build and operate the extremely costly clean room suites for those processes, and removing the need for personnel to work in sterile lab suits. This will greatly reduce the DCVax-L production costs.


The buildout of the Sawston, UK facility has purposely been designed to proceed in phases, as modules, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. Implementation of the Flaskworks system will enable certain phases of the buildout to be simplified and streamlined.


The existing manufacturing process for DCVax-L products already takes a practical and economical approach by using a batch manufacturing process combined with special cryopreservation technology. The full set of doses for a patient, for as much as 3 years of treatments, are all produced in a single 8-day manufacturing batch, and then are stored frozen in single doses. The freezing technology has been validated and was used throughout the Company's Phase 3 trial. This makes DCVax-L an off-the-shelf product for the whole treatment period after the one-time manufacturing batch, while also being a fully personalized product.


The Flaskworks system will follow the same batch-manufacturing process – doing so in a "closed" and automated manner.


Certain optimization work will be required so that the Flaskworks system will produce DCVax-L products with characteristics equivalent to the products made by the current DCVax-L manufacturing processes. This will then need to be confirmed by comparability studies. The Flaskworks technical team will work with NW Bio's contract manufacturers to accomplish this. In the meantime, the Company's DCVax products will continue to be made through the existing processes.


The acquisition of Flaskworks was executed and closed on August 28, 2020. The total purchase price was approximately $4.33 million, of which $1.65 million was paid in cash at closing, up to $2.01 million will be paid in stock subject to milestone-based vesting, and $0.67 million will be paid in either cash or stock, or a combination thereof, within 120 days after the closing.


The acquisition includes both intellectual property owned by Flaskworks and a license of additional intellectual property from Northeastern University.


Although a number of companies have developed and are continuing to develop automated machines for certain cell therapy production processes, those machines have certain drawbacks. For example, they typically try to handle a variety of cell types and have not been optimized for a particular cell type, such as dendritic cells. In contrast, the Flaskworks system has been developed and tailored specifically for immune cells such as dendritic cells.


Linda Powers, NW Bio's CEO commented, "We believe that our DCVax platform technologies are potentially applicable to all types of solid tumor cancers, which comprise the vast majority of all cancers. We are working to build the infrastructure and systems that can enable the scale-up of production to such volumes – and can do so at a price level that will be affordable for widespread use of DCVax treatments."


"The phased buildout of our Sawston, UK facility and now our acquisition of Flaskworks are major building blocks towards achieving these goals. These steps, along with others in process, have been years in the making to reach fruition at the same time as we are reaching the results of our Phase 3 clinical trial of DCVax-L for Glioblastoma."


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." The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial, and is preparing for 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 enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the 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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Stock price has been rising fast as some positive news are known.



Late-Breaking
Clinical trials: Immunologic

Plenary I

LTBK-02 - Phase III Clinical Trial to Test the Safety and Efficacy of Autologous Tumor Lysate-Loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma
Friday, November 20, 2020


  • Live Abstract Presenter(s)
  • GQLULUHR-Presenter-LiauL.jpg





    Linda Liau, MD, PhD

    Director, Brain Tumor Program, UCLA David Geffen School of Medicine
    University of California Los Angeles

    Arbor Pharmaceuticals (Consultant)JW Creagene (Consultant)




  • Author(s)
  • MB




    Marnix Bosch, MBA, PhD

    Northwest Biotherapeutics

    I do not have any relevant financial / non-financial relationships with any proprietary interests.





Participants should be aware of the following financial/non-financial relationships:
Linda M. Liau, MD, PhD: Arbor Pharmaceuticals
(Consultant)JW Creagene (Consultant)
Marnix Bosch, MBA, PhD: No disclosure data submitted.

Background: Glioblastoma (GBM) is an incurable form of brain cancer with a high mortality rate in which multiple treatment attempts over the past decade have proven unsuccessful at extending survival. Early stage data have suggested that immunization against tumor cell antigens may be effective in GBM. In this Phase 3 study we aimed to assess whether autologous dendritic cells (DCs) loaded with autologous tumor cell lysate, is able to improve survival in these patients.


Methods: We conducted a randomized, double-blind,placebo-controlled international Phase 3 clinical trial with autologous tumor lysate-loaded DCs (DCVax®-L) in 331 patients with histologically confirmed newly diagnosed GBM. Following surgery and chemoradiation, patients were randomized 2:1 to receive temozolomide plus DCVax-L or temozolomide plus placebo (i.e. autologous PBMC). Eligibility criteria included an intent for significant tumor resection (not biopsy only), sufficient doses of DCVax-L manufactured for 5 or more immunizations, and no radiographic evidence of apparent disease progression at the end of chemoradiation. A crossover option allowed all patients to receive the autologous vaccine at the time of disease progression. As a result, 90% of the randomized patients received DCVax-L at some point during their participation in the trial. Study subjects received immunizations with 2.5 million DCs or placebo at days 0, 10 and 20, followed by immunizations at months 2, 4, 8, 12, 18, 24 and 30. All subjects were assessed for progression-free survival (PFS) and overall survival (OS). This trial is registered with clinicaltrials.gov, number NCT00045968.
Learning Objectives:
  • Upon completion, participant will be able to better understand the impact of dendritic cell-based immunization strategies o the course of disease in glioblastoma patients.
  • Upon completion, participant will be able to assess whether patients with glioblastoma live longer if treated with dendritic cell-based immunization strategies.
 

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Thank God, I am finally green, hugely green now, mostly in paper profit of course but I did sell some in honoring my discipline in trading for not to getting too greedy. Plan to hold the vast majority of my shares for a long term.

Topline data will be announced in September, and it seems details will be discussed on 20 Nov.

Hope some CFCers got in this stock and also finally realize some profit.
 
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I have bought more yesterday at around $0.55.

Courtesy of sintient_stocks over in ihub:

Linda Powers' presentation at the American Brain Tumor Association 2020 National Conference on Saturday, September 12, 2020.

Thanks to Shaun Franklin, or "snoopy comic", for his very helpful recording of it. It's so good to finally hear from LP again. And great to hear that they are still on track for top line in September.


Quote:Hello, my name is Linda Powers. I’m the CEO of Northwest Biotherapeutics. Our company is developing personalized immune therapies for cancer. Particularly brain cancer. We’re very pleased to be able to support ABTA’s Annual Meeting 2020, and we think ABTA’s work in the field is super important, super helpful for the whole field.

I’d like to take about five minutes to just talk about three subjects that I think may be of interest to folks. Firstly, the key challenge for immune therapy is in trying to treat solid tumor cancers. Secondly, I’d like to describe a little bit about some of the key elements of the immune system, the human immune system, that offer a real opportunity for, we believe, powerful treatments for cancers. And thirdly, I’ll describe a little bit about our particular approach with our DCVax technology. I will flag, right from the beginning, we’re very excited because just in the next couple weeks, later this month of September, we will be expecting to UNBLIND, UNVEIL, and ANNOUNCE, **finally,** the results of our THIRTEEN YEAR LONG PHASE THREE TRIAL OF DCVAX FOR GLIOBLASTOMA BRAIN CANCER. And we think this study is going to be a major contribution to the field in terms of data, and we certainly hope to be able to bring a new treatment option to patients. So please stay tuned to see those clinical trial results in just a few weeks.

So the key challenge for immune therapies, and really for other therapies too, in trying to treat solid tumors is that they are so highly, highly variable. Solid tumors comprise the vast majority of all cancers. These are tumors in any tissue of the body, as opposed to blood cancers or lymphomas. And the variability, the heterogeneity, is really at all levels. Firstly of course, there’s a lot of variations among cancers: brain cancer is different than lung or colon cancer. There’s also extensive variations among patients, even who have the same cancer. For example, breast cancer or brain cancer, the patient may have MGMT methylated or unmethylated. They may have an IDH mutation or not. So (there are) variations among patients. They are even variation within a single patient the disease progresses over time. And strikingly, even a lot of variation within a single tumor in a single patient at a single moment in time. If you take a biopsy from one part of a single tumor, you may get a very different profile than a biopsy from a different part of the tumor.

A challenge, because most cancer therapies have taken the approach of precision targeting, and trying to be as laser precision-focused as possible with a single activated agent, and a single target on the cancer. Kind of a silver bullet approach. But the tumor can mutate and escape from that. So nature has built in an immune system that’s really well structured to help stop these tumors and treat them. So you have the innate arm of the immune system, and the adaptive arm. And they are complimentary to each other. The innate one, the innate arm is your first responders. They’re rapid responders within hours or days. Those immune cells are basically born with a built in library to recognize things that are bad… bacteria, virus, tumors, etc.

The adaptive immune system follows on and takes longer, weeks or months, or even longer, to respond. And here, we particularly focus on the T-cells, a very important foot soldier… both helper T-cells and killer T-cells. Although, of course, we have the B cells and antibodies as well. But importantly, over the top of all of this is the master immune cell… the master cell of the immune system called a dendritic cell. Sort of the general of the army. The job of the dendritic cell is to identify anything bad in the patient’s body, pick up the information, process it, and present it to all of these other immune players, immune agents, in the immune army, so that they’re all activated to attack those bad things that the dendritic cell identifies. The dendritic cell is actually very efficient at doing this. The dendritic cell, when it picks up the information about the tumor or the pathogen, presents it to the T-cells, for example, and activates the T-cells to spread out, fan out, throughout the whole body looking for the bad thing to attack. And each one dendritic cell mobilizes hundreds of T-cells, both large numbers of T-cells and diverse T-cells to attack different biomarkers or antigens on the tumors or other pathogen or “bad thing.”

So the approach that we’re taking in DCVax is FOLLOWING NATURE'S SYSTEM. We’re using the dendritic cell as the active agent, and having the dendritic cell mobilize all of those immune agents to work together to attack the tumor. In addition, it’s fully personalized. We use the patient’s own immune cells and the patient’s own tumor tissue sample. So we know that we’re getting the right version of the targets on the cancer, and we don’t have a Russian roulette issue about whether the patient’s does or doesn’t express the target as cancer drugs typically have that issue.

And lastly, we use the full set of tumor biomarkers, or tumor targets. It’s not just one or a few, or five or six. This makes it as difficult as possible for the tumor to escape. And so with this combination, (with) many weapons hitting many targets, we’ve seen very encouraging results in our early stage trials, mid stage trials, and compassionate use. So please stay tuned for the results of our phase three trial. We’re really hoping to be able to bring this as a new treatment option for patients in the field. Thanks so much.



 

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Dan88 Saturday, 09/12/20 03:25:26 PM
Re: sentiment_stocks post# 306724
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Post # of 306810


I am not a fan of parsing words, but let me try this time:

Linda says courtesy of sentiment_stocks, "we will be expecting to unblind, unveil, and announce, finally, the results of our thirteen year long phase three trial of DCVax for glioblastoma brain cancer"

My parsing:

we will be expecting to unblind, unveil, and announce, finally, the results of our thirteen year long phase three trial of DCVax for glioblastoma brain cancer [to the general public].

Suggesting/indicating DL has been completed [why not, that outside data doesn't need a few weeks to be incorporated into the main database], they [at least maybe only two Lindas at this time]are made aware of part of the positive unblinded data from statisticians, and the company will be expecting to unblind, unveil, and announce [the results] to the general public at later this month.

Hence, SNO late breaker abstract and planned presentation on 20 Nov.

In summary, DL done, statisticians unblinded, Linda partially unblinded, topline data announcement later this month carved in stone -- this has always my thinking recently

Hence, I have averaged up several times after 1 Sep, including yesterday.
 

CFCBUG

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Is it a good price to buy and hold at 0.66?
Thanks!
 

GlobeCitizen

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I cannot definitely say yes. You have to make your own decision. I have dumped enough information onto this thread which can help you when you do your own DD. Right now one thing is almost certain that the results of this 13-year long DCVax-L Phase 3 trial for GBM will be announced late the month of September, meaning anytime from now to the end of September 2020.

If successful, the price will be substantially appreciated. Use today's NVCR MC as reference for example, the share price will at least ultimately reach $10. However, if DCVax_L is not approvable by any of the four countries involved (US, UK, Germany and Canada), then share price will crash.

Note: NVCR owns Optune, a FDA approved device for the treatment of GBM. It is widely believed if NWBO's DCVax_L is approved by FDA, it will readily replace Optune, and more.



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