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Fascinating article Abeta! Thank you!
Will NWBO has ASM this year? Is that legal without annual ASM?
Re: None
Saturday, October 01, 2022 5:51:55 PM
Post#
518324
of 518351
Sept 30 2022 - Glioblastoma recurrence reveals novel and targetable immunoregulatory drivers
NOTE: p means Primary
We, therefore, quantified the transcriptome and proteome of 134 patient-derived pGBM and rGBM samples, including 40 matched pGBM-rGBM pairs.
GBM subtypes transition from pGBM to rGBM towards a preferentially mesenchymal state at recurrence, consistent with the increasingly invasive nature of rGBM.
We identified immune regulatory/suppressive genes as important drivers of rGBM and in particular 2-5-oligoadenylate synthase 2 (OAS2) as an essential gene in recurrent disease.
Our data identify a new class of therapeutic targets that emerge from the adaptive response of pGBM to therapy, emerging specifically in recurrent disease and may provide new therapeutic opportunities absent at pGBM diagnosis.
https://pubmed.ncbi.nlm.nih.gov/36178522/
note - the above is the abstract and I don't know how to get to the whole article
other than paying about $40 bucks
Sidebar
2',5'-oligoadenylate synthase (OAS) is a class of enzymes induced by interferons and mainly encoded by the OAS1, OAS2, and OAS3 genes, which activate the potential RNA enzymes to degrade viral mRNA, inhibit viral protein synthesis and promote apoptosis in virus-infected cells. OAS3 is associated with breast cancer prognosis. However, the expression and prognosis of OAS3 and tumour-infiltrating lymphocytes in pan-cancer remain unknown. In the present study, we have systematically investigated and confirmed the role of OAS3 in tumour immune infiltration, immune escape, tumour progression, response to treatment, and prognosis of different cancer types using various bioinformatics methods. The findings suggest that OAS3 is aberrantly expressed in almost all TCGA cancer types and subtypes and is associated with tumour staging, metastasis, and prognostic deterioration in different tumours. In addition, OAS3 expression is associated with the prognosis and chemotherapeutic outcomes of various cancers. In terms of immune-infiltrating levels, OAS3 expression is positively associated with the infiltration of immunosuppressive cells. These findings suggest that OAS3 is correlated with prognosis and immune-infiltrating levels.
https://pubmed.ncbi.nlm.nih.gov/35592250/
Calling a link to a talk by liau a “pump” seems strange to me- have a great one Bobby!
Judge, But 50 dma has not crossed 200 dma (78cents). Why you call it golden cross now? I am confused.
well stated bio
1) Nowhere in my post did I say you said they were mismanaged. Why are you even asking?
2) Where did I say, repeatedly "all this silence is normal". These kinds of attacks are not NORMAL. These kinds of campaigns only happen to very particularly targeted companies. I agreed with you that yes, they had not had any quarterly calls
This is exactly what I said to the comment to which you just replied.
"I said no, they haven’t had quarterly calls HFT3. I did not say that was typical. However, in my experience with companies like this, single product companies that have been massively shorted by hedge funds, it actually is quite typical to go silent. And in this case, given what I know now, I honestly believe it was the right strategy. The attacks on this company are so nasty and determined, I have no doubt they would have destroyed it. I don’t thing that would have served the interests of anyone but those shorting the company and I don’t believe therefore that I have missed anything or been disadvantaged by it. "
David, you are right I did not list the 200. I posted the 50 and the 100 bc they are on top of each other and we are imminent for 50 to cross the 100.
I called it the silver cross as a joke. But it’s a step in the right direction bc the 50 has to get over the 100!before it gets back over the 200. The 200 which is not listed is currently at 78
thanks for the chart and explanations judge!
I hear you ILT. Just wanted to be clear that I don't see that there is a clear strategy for companies to rebut those strategies and I don't see these posters as always just a few idiosyncratic posters but often they are part of what I would call troll farming efforts. These efforts don't just happen and then continue for years. There are economic interests behind them, I believe.
My views are based on my own experience with project finance and doing deals to make facilities and other projects happen.
Cognate actually invested in NWBO at very high share price by doing the work as a supplier for shares instead of cash. What is typical of such a deal is that the shares are paid at the current share price at that time, but such contracts typically have a most favored nation's clause that ensures that the end party gets shares worth the value of services provided. Typically the mechanism is not on a daily basis but is triggered when the company itself does a direct issuance. So secondary market trades don't trigger it typically. What happened was that shorts scour filings for clauses like these, but they take down the company shares by insinuating all sorts of negative things that have nothing to do with the clauses. The result is that they can trigger massive dilution, which then creates an avalanche in the share price, and the company basically is like a piñata for the hedge funds.
Those financings always sound great in the abstract, but no one expects that people will be so evil as to take things actually in financial statements, and then weaponize them through implication and suggestion, as if they are not there or as if they are not just basic issues or risks. Something like that happened here, they collapsed the share price, triggered years worth of expenses to come due immediately as shares from the company, and then used that to suggest something bad was happening between the two, which of course allowed them to keep at it. Shorts love to make a mess of these companies and then they might wait to take the assets out of bankruptcy and reflect them, or keep it private, or sell it all to another large player and they get the profit all the way down, get the assets basically stolen from naive shareholders and turn that into another billion or more in a sale or an IPO.
Wicked vulture traders. Quite nasty.
So in the end, the two companies needed to settle up old debts and renegotiate some. Cognate had its own factory and facilities, so it was not the same as this, and NWBO was nowhere near as far along when that relationship was struck. My sense of it was that there were not a lot of CDMO's or any players doing anything commercial in the dendritic cell space, and the players out there were more in the stem cell and other cell space. This is autologous too, which is also a different animal than what a lot of the cell manufacturing companies were doing. We can see from Car-T sector and Dendreon before, that really, it was very much by hand kind of by hand process that was not industrialized. So getting scale in the manufacturing of these kinds of treatments would be an advantage to everyone if it could be done. So Cognate was really a first attempt at that I believe and of course they were ultimately bought by Charles River, though I think they needed to sell at that point because basically all of NWBO's trial manufacturing was done already and there was nothing going on with their biggest customer, they were waiting for survival data, which as we know takes a long time, and I don't see a lot of other companies climbing into this space. Charles River had the resources to wait it out and be prepared for a whole new segment which I think, when they evaluated that opportunity, they likely looked at companies like NWBO and saw what is not obvious to your average investor.
Judge, please help me. where is 50 ? and 200?
We have chance for Oct, but probably be Nov to cross Centerline & 50 get > 200.
I, hoping we get some good news for the sake of cancer patients.
Daily Chart 10 Month View ~ Circled Monster Gap in Dec that is causing us to mess around with 68 & 75 level so much. I'll give Feedback from Top to Bottom:
1. Top Indicator is short term MACD ~ Year Long Support / Trend Line in play - also on Centerline. "Power Moves happen on Centerline"(I Patented that saying).
2. ROC with EMA..Pretty self explanatory. Great tool I created shows clear direction of stock. We had brief drop below and quickly popped back above(And Centerline). We all that Whipsaw to the good way.
3. Can see 50 about to cross 100 ~ Silver Cross this week.
4. Finding Support on Cloud, and also outlined Bull Flag / Falling Wedge we are in.
5. Bottom Indicator one of my favs...Long Term MACD 65,90,12. Can see the Blue circles I made when we have crossed and action that followed so far this year.
Bonus Tip....MACD setting of 65,90,12 also correlates with 50/200 Golden Cross. In other words, when this MACD crosses the Centerline, that will be with 50 will cross 200....They are closely tied at the hip most of the time. Can also observe we have made Higher Lows in 2022 for this Long Term MACD. We have chance for Oct, but probably be Nov to cross Centerline & 50 get > 200.
Sorry for the error.
It’s a 10 minute slot so it will be a nothing burger. If it was something massive, exciting & different then they would have given her more time and an important slot. I’d actually be happy if we don’t get taken down after SNO like NYAS.
Whoseleft - There have been a few fascinating breakthroughs by lonewolfs, who were resourceful stewart's of unconventional scientific approaches, and because their concepts were either not patentable, or patentable but not available to buy-off, or so incredible to believe, that the pharma barons chose to destroy any chances of these discoveries from seeing the light of day.
ILT
Biosect - If you reread my post, you'll understand that we aren't apart in our view of how rediculous a proposition would be to reflexively put out postings for any public company as a strategy to shut down falsehoods. I feel the same exact way about an investment community that can't draw the line in the sand from responding to such "RainMan like utterances" of the same false identical narratives, thinking that somehow a) they will stop and see the light, or b) stop period. One or two odd posters who can't find something new, but to play the same song, doesn't make for good listening or most popular. Unfortunately, it's not that I don't believe people aren't gullible, that I do know, but the preponderance of the long view on this board makes the efforts of the lone hitman a near impossibility to achieve whatever their misguided objectives are.
ILT
Thank you Captain, good to see warrants being exercised helping fund our company in these final stages before revenue starts to pour in! GLTA
The gift that keeps giving might prove to be very beneficial in humanity's fight against cancer! We know viruses are responsible for some cancers if not most, HPV for one is well documented. Hopefully we can turn viruses into a friend instead of a bloody enemy! GLTA
https://www.insider.com/mans-cancer-vanished-after-injection-with-weakened-herpes-virus-2022-9?amp
Code blue, code blue
50 CCs lidocaine stat
Charging……. Clear……
Zap!……… beep.. beep..
We have a pulse!
Sept 30 2022 - Glioblastoma recurrence reveals novel and targetable immunoregulatory drivers
NOTE: p means Primary
We, therefore, quantified the transcriptome and proteome of 134 patient-derived pGBM and rGBM samples, including 40 matched pGBM-rGBM pairs.
GBM subtypes transition from pGBM to rGBM towards a preferentially mesenchymal state at recurrence, consistent with the increasingly invasive nature of rGBM.
We identified immune regulatory/suppressive genes as important drivers of rGBM and in particular 2-5-oligoadenylate synthase 2 (OAS2) as an essential gene in recurrent disease.
Our data identify a new class of therapeutic targets that emerge from the adaptive response of pGBM to therapy, emerging specifically in recurrent disease and may provide new therapeutic opportunities absent at pGBM diagnosis.
https://pubmed.ncbi.nlm.nih.gov/36178522/
note - the above is the abstract and I don't know how to get to the whole article
other than paying about $40 bucks
Sidebar
2',5'-oligoadenylate synthase (OAS) is a class of enzymes induced by interferons and mainly encoded by the OAS1, OAS2, and OAS3 genes, which activate the potential RNA enzymes to degrade viral mRNA, inhibit viral protein synthesis and promote apoptosis in virus-infected cells. OAS3 is associated with breast cancer prognosis. However, the expression and prognosis of OAS3 and tumour-infiltrating lymphocytes in pan-cancer remain unknown. In the present study, we have systematically investigated and confirmed the role of OAS3 in tumour immune infiltration, immune escape, tumour progression, response to treatment, and prognosis of different cancer types using various bioinformatics methods. The findings suggest that OAS3 is aberrantly expressed in almost all TCGA cancer types and subtypes and is associated with tumour staging, metastasis, and prognostic deterioration in different tumours. In addition, OAS3 expression is associated with the prognosis and chemotherapeutic outcomes of various cancers. In terms of immune-infiltrating levels, OAS3 expression is positively associated with the infiltration of immunosuppressive cells. These findings suggest that OAS3 is correlated with prognosis and immune-infiltrating levels.
Thanks biosectinvestor! Between your response and hoffmann's I think understand what is going on with Advent. Was this the same arrangement with Cognate (loans with stipulations to provide access to others, etc)?
It’s a private company, but the rate they are being paid appears to be fair and reasonable and the fact is, there is nothing on the NWBO balance sheet that suggests they have capitalized Advent. What is clear is advent does not have its own facility, it is a contract manager. It pays NWBO a substantial rent, and needs approvals u believe to take on work in the factory if it would take away from plans by NWBO. It is a symbiotic relationship and the facility received regional development loans at a good rate in order to develop the facility with the promise that local scientific and commercial endeavors would have access to the facility. NWBO would not have received that loan were it not able to provide access to the facilities, but it would be a gross waste of resources for NWBO to man up to provide those ancillary manufacturing services itself.
So this is a very beneficial relationship. NWBO owns the factory, I can’t imagine another contract manufacturer willing to manufacture at a start-up company’s own factory other than an early stage CDMO with no capital sunk in facilities of its own.
In the end, basically the local regional authority has funded NWBO’s facility so long as it provides a certain, reasonable amount of access to its facilities and capacities to develop this sector in the region. I think it was a fair bargain. I don’t know of any companies that would refuse such funding generally at this stage of their development.
that would certainly help!
Sure, there is potential value in owning anything. Yet, owning a Contract manufacturer during startup is probably a significant cash drain. Cash that DNDN didn't have and NWBO doesn't have right now. 'Owning something' is a very general statement. You have to get into the finances to really know whether it is worthwhile. I trust NWBO knows what they are doing.
DNDN had manufacturing issues but even worse were (still are for Provence) competition and lack of reimbursement, which is why getting SOC status is so important
Thanks hoffmann6383. I remember DNDN from years past. That was a sad situation.
I see Advent has at least a couple of other clients based on their website. How is Advent being funded beyond getting paid for the work they are doing for NWBO? As you say, manufacturing is expensive. We don't want them to go broke. I see they've been doing a lot of hiring...a lot of mouths to feed!
Do you think there would be any value in at least some ownership interest in the manufacturing side?
I said no, they haven’t had quarterly calls HFT3. I did not say that was typical. However, in my experience with companies like this, single product companies that have been massively shorted by hedge funds, it actually is quite typical to go silent. And in this case, given what I know now, I honestly believe it was the right strategy. The attacks on this company are so nasty and determined, I have no doubt they would have destroyed it. I don’t thing that would have served the interests of anyone but those shorting the company and I don’t believe therefore that I have missed anything or been disadvantaged by it.
As I said, I am up, overall, almost 60% per year for 5 years, if that is mismanagement, AND we have a successful trial in my estimation, with a potentially blockbuster new treatment about to hit, well, then I want to find more companies like this one.
SkyLimit2022
Re: HyGro post# 518282
Saturday, October 01, 2022 2:01:10 PM
Post#
518288
of 518312
Thank you for publishing the slides. You are correct—everyone should study and research ALL of the slides to properly understand the landmark trial. Everyone should do thorough research of trustworthy sources and not accept anonymous disinformation as true. I agree 100%.
September 14, 2022 Update of NIH NCI Funding of Dr. Liau
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
9/14/2022
In a trial now underway, a dendritic cell vaccine is made from a participant's own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
"What I'm excited about is that we're seeing a
growing number of long-term survivors in our
patients treated with immunotherapy
combinations," Dr. Liau says. "We're seeing some patients with certain combination
immunotherapies that are living for many more
years than would be expected. Currently, we're
trying to find out what combination works best and for which patients."
https://cancer.ucla.edu/research/ucla-brain-spore
https://www.merck.com/stories/fighting-cancer-requires-an-open-mind/
Merck: “Personalized cancer vaccines which are therapeutic vaccines based on patients’ specific cancer that could potentially prime the immune system to recognize certain characteristics and attack the cancer cells”
https://m.youtube.com/watch?v=Oq39FFUwKug
DCVax is discussed beginning at minute 40, to focus on Keytruda (pembrolizumab) plus DCVax in combo at UCLA, skip to minute 45:40
NCI, Merck, & PHASE ONE are today supporting collaborators on the UCLA Keytruda trial—100% of patients in both the experimental group AND the placebo group receive DCVax. Only Keytruda in combo is being investigated—everyone receives DCVax as if it were SOC.
Group A (pembrolizumab, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group B (placebo, ATL-DC, poly ICLC)
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
https://clinicaltrials.gov/ct2/show/NCT04201873
Dr. Linda Liau is a world-renowned neuro-oncologist, surgeon, and educator at UCLA where she is also the chair of the department of neurosurgery. As her paper on DCVax moves through the independent peer review process, it is interesting to note that she was once the editor-in-chief of a neuro-oncology medical journal.
https://www.uclahealth.org/providers/linda-liau
https://doi.org/10.3171/2020.12.FOCUS20954
https://soc-neuro-onc.org/
Across the pond from Dr. Liau, Dr. Ashkan was the chief investigator of the DCVax trial for patients in Europe. At King’s College in London, Ashkan is the lead clinician for neuro-oncology and the chair of the King’s Neurosciences Clinical Trial Unit. He is a world-renowned cancer trial expert. A few years ago, Professor Ashkan was named the UK Clinician of the Year by The Brain Tumour Charity. Additionally, Ashkan serves as an advisor to the U.K. government.
https://www.kcl.ac.uk/people/keyoumars-ashkan
https://m.youtube.com/watch?v=h_tev1qm1ZE&feature=youtu.be
https://virtualtrials.org/dcvax.cfm
Richard Pazdur, M.D. is the director of the FDA's Oncology Center of Excellence (OCE), which leverages the combined skills of the FDA's regulatory scientists and reviewers with expertise in drugs, biologics and devices to expedite the development of novel cancer products. In his role as director of the OCE, Pazdur is responsible for leading the effort to develop and execute an integrated regulatory approach to enhance the cross-center coordination of oncology product clinical review.
Pazdur has published more than 400 articles, book chapters and abstracts. In 2015, Fortune magazine named Pazdur as one of the 50 World’s Greatest Leaders. The American Association for Cancer Research recognized Pazdur with its Distinguished Public Service Award (2015) and the American Society of Clinical Oncology recognized him with the Service Recognition Award (2009) and the Public Service Award (2013). In 2015, Pazdur also received the Public Service Leadership Award from the National Coalition for Cancer Survivorship and also the Face of Hope Award from the LUNGevity Foundation. Most recently, in 2016, Pazdur was named to Massachusetts General Hospital Cancer Center’s “The One Hundred” list.
"Now we are in the era of immunotherapy"
-Richard Pazdur, MD
"Often, novel agents are so obviously superior to standard of care that no patient would participate in a randomized trial knowing that somebody else might get the experimental drug
-Richard Pazdur, MD
"There's also been a revolution in tumor immunology. Before, in my early career, tumor immunology was looked at kind of as black magic, as witchcraft. Now it's accepted."
-Richard Pazdur, MD
"When we make a decision about approving a drug, it has to be patient centered. It can't be about the regulations"
-Richard Pazdur, MD
https://www.annalsofoncology.org/article/S0923-7534(22)00006-0/fulltext
https://www.fda.gov/drugs/news-events-human-drugs/50-years-progress-treating-patients-cancer
https://www.webmd.com/cancer/cancer-in-context/video/richard-pazdur
https://www.onclive.com/view/pazdur-followed-the-pathway-of-greatest-resistance-to-the-fda
So many of these survivor stories are old news— research 2022 updates—some are GBM patients surpassing a decade or multiple decades—miraculous …
https://www.hawaii.edu/news/2017/03/30/newirth-laker-for-a-day/
https://m.youtube.com/watch?v=K9azZaIwOH8&feature=youtu.be
SkyLimit2022
Re: HyGro post# 518280
Saturday, October 01, 2022 2:03:57 PM
Post#
518290
of 518313
Fact check:
Research it for yourself:
https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter
https://www.bentley.edu/news/nih-funded-research-related-every-new-cancer-drug-approved-2010-2016
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
https://newsroom.ucla.edu/releases/nih-grant-lab-gene-cell-therapies
https://connect.uclahealth.org/2021/03/22/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020/
SkyLimit2022
Re: HyGro post# 518152
Saturday, October 01, 2022 3:06:17 PM
Post#
518297
of 518313
https://soc-neuro-onc.org/
September 2022–
In a trial now underway, a dendritic cell vaccine is made from a participant’s own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
“What I’m excited about is that we’re seeing a growing number of long-term survivors in our patients treated with immunotherapy combinations,” Dr. Liau says. “We’re seeing some patients with certain combination immunotherapies that are living for many more years than would be expected. Currently, we’re trying to find out what combination works best and for which patients.”
March 2021–
Supported by the NIH’s Brain Initiative and the National Cancer Institute’s Specialized Program of Research Excellence (SPORE) grant, Dr. Liau is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases. Engaging in research also makes her more effective bedside, she says.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful…”
November 2022–
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
https://www.uclahealth.org/providers/linda-liau
https://virtualtrials.org/dcvax.cfm
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
SkyLimit2022
Re: Bob_LobLaw post# 518299
Saturday, October 01, 2022 3:39:06 PM
Post#
518305
of 518313
The recent developments are heating up for sure. Yes, I agree that SNO is significant, but don’t forget all the other institutions that were involved leading up to SNO 2022 and the forthcoming peer-reviewed publication: NIH, King’s College, UCLA, MHRA, and the Nobel Prize-winning discovery of the dendritic cell that led to the landmark development of the DCVax platform technology…
These and so many more..
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
https://virtualtrials.org/dcvax.cfm
manufacturing is expensive. it can bankrupt you. See DNDN. NWBO learned from other companies mistakes and are taking a cost conscious approach. As You point out, NWBO owns the tech. That is all that matters.
Great post SkyLimit2022, agree with you that people need to do their research and not trust confounded opinions but focus on the facts, OS data proves that DCVax-L works.
I've been following NWBO for sometime, but more on the surface and less in-depth. I'm starting to dig below the surface a bit and am asking veteran shareholders that post their knowledge and insight on this board on a regular basis for some knowledge and insight into the questions below.
It appears that NWBO has spent considerable funds on the build out of the Sawston plant in the UK. They sublet the building that is owned by Huawei to Advent Biosciences (Advent) and are paying Advent for this exclusive build out. Advent is the result of a spin off of Cognate BioServices.
From the most recent SEC filing, the above arrangement is similar to the arrangement they had with Cognate in the US. Cognate has since been bought out by Charles River Labs. Does NWBO have exclusive access to what was built out at Cognate as it is described regarding Advent and the Sawston plant?
I've seen commentary regarding the Cognate situation in that the CEO of NWBO also had a substantial ownership interest in Cognate and people complained that the CEO was benefiting financially from NWBO's funds spent on Cognate related expenses. What was the reason that NWBO didn't pursue some sort of ownership interest in Cognate and now Advent?
A little over two years ago, NWBO surprised me in buying out Flaskworks. I believe this to be a nice move as it appears Flaskworks has uses beyond the mass production of DCVax. I also find this similar to the Cognate and Advent situations. All three companies have or are building something that NWBO will use now and/or in the future and other companies may find what all three companies have to be useful for them in the future, but NWBO will only benefit from Flaskworks. Why would NWBO buy out Flaskworks but not have ownership interests in the manufacturing build outs done for them by Cognate and now Advent?
Great post SkyLimit2020, as Dr Linda Liau continues to support DCVax.
"So NWBO SEC filings is what??"
Required by the SEC
The recent developments are heating up for sure. Yes, I agree that SNO is significant, but don’t forget all the other institutions that were involved leading up to SNO 2022 and the forthcoming peer-reviewed publication: NIH, King’s College, UCLA, MHRA, and the Nobel Prize-winning discovery of the dendritic cell that led to the landmark development of the DCVax platform technology…
These and so many more..
https://www.livescience.com/16354-nobel-prize-medicine-2011-immune-research.html
https://virtualtrials.org/dcvax.cfm
Repeat and repeat, but the real fact of the matter is that NWBO succeeded
as the OS data results have already proven so thanks for pointing this out
again, and again. NWBO is on the right track.
Biosect, quarterly calls are really a very normal thing even with single product companies with that product still in development. In the case of nwbo for the last 2 years of 'quiet period' they still could have given updates on construction and patent progress. To me silence is quite out of the norm and leaves at least some shareholders wondering what if anything is actually going on. It has caused a number of my group of investors to give up sell and just move on. Leaves me to wonder if I am the wise one to continue to hold ( I think/hope so) or if my friends made the better choice. I hold not because of management but due to all the research and presentations from the dedicated scientists. Still I often think that I could have bailed near $2.00 with a multiple 6 figure gain
I had a small biotech (AVNR) that had single product that was continually bashed by AF yet they always gave shareholders a quarterly update - sometimes what they said was not favorable but could at least see that they were working toward the endpoint of trial success (with setbacks some quarters) but gave me confidence to hold and ended up a 10x or better winner. I for one would like similar quarterly calls from nwbo and not worry about AF
I’m not sure but it also means when it is time to go that should stop. I’m hoping that is soon.
No one is pumping anything. SNO is a big conference and actual shareholders are excited to hear their company data talked about by one of the top neurosurgeons in the world.
Have a good one Bobby.
- TS
And the SNO pump is upon us!!!! Get to work fellas!
https://soc-neuro-onc.org/
September 2022–
In a trial now underway, a dendritic cell vaccine is made from a participant’s own tumor tissue and combined with an anti-PD1 immune checkpoint inhibitor to counter resistance when either treatment is used alone. The checkpoint drugs work by blocking the proteins that stop the immune system from attacking cancer cells.
“What I’m excited about is that we’re seeing a growing number of long-term survivors in our patients treated with immunotherapy combinations,” Dr. Liau says. “We’re seeing some patients with certain combination immunotherapies that are living for many more years than would be expected. Currently, we’re trying to find out what combination works best and for which patients.”
March 2021–
Supported by the NIH’s Brain Initiative and the National Cancer Institute’s Specialized Program of Research Excellence (SPORE) grant, Dr. Liau is collaborating with research faculty in neuroscience, oncology and immunology to develop those brain cancer vaccines and other novel treatments for brain diseases. Engaging in research also makes her more effective bedside, she says.
“It's the stamp of approval from the NIH, because these types of grants are so rigorously peer-reviewed,” Dr. Liau says. “People get funded based on the strength of the science and that, itself, is very powerful in terms of showing that our research is scientifically valid and meaningful…”
November 2022–
Dr. Liau will be presenting DCVax at the annual Society for Neuro-Oncology meeting in November.
“The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education.”
https://www.uclahealth.org/providers/linda-liau
https://virtualtrials.org/dcvax.cfm
https://connect.uclahealth.org/2022/09/14/brain-cancer-discovery-clinical-trials/
I hear you. Best strategy is to let her win and smile.
Most of this is not materially different than any other company tiny microcap in this sector and some of it is exaggerated.
As for making “money”, well, I am up 60% even at this price, per year for the last 5 years on my investment. That’s better than most investments out there right now, and they do not yet have a product to sell, which is typical of microcap, single product biotechs at this stage.
People who don’t understand this, should not invest in such tiny companies. They do because upon approval and having a product, the companies valuations typically explode upward. We have seen volatility here that likely allowed some to sell and make millions here had they wanted the short-term profit.
As for quarterly calls, no, they haven’t. They had one product in trial and not a lot to say while they waited for OS data. It was likely a bit like waiting for paint to dry. Quarterly calls would have made the stock the target of unscrupulous hedge funds and their minions on social media, and they would have taken advantage of what they themselves dub, “stupid retail” to undermine the price while they waited to buy as cheaply as possible, just before value recognition or they bought the assets for cheap after creating a bankruptcy themselves and then relocated the same trial and drug under a private company that they ran to have all of the profit.
Wall Street is ruthless. They attack things they know are valuable not because they hate them but because they are greedy and want them ALL to themselves. That’s just the reality. Patent trolls and others swoop these things up cheaply and make billions of dollars off of what they call “the stupidity of retail”.
That is in the “risk factors” section and they also explained, as they did in their presentation how they dealt with it. The purpose of the Risk Factor sections of SEC filings is to warn investors of things that MIGHT happen, not what will happen. They cover all kinds of bad things and if floods or hurricanes were a big factor it would cover those too, to ensure that in any court, it could be said that the “investor had been warned” about potential risks and they knew and accepted those risks. This is not a bank CD.
We all know they have not received product marketing approval, which is different to saying that the change in the Statistical Analysis Plan was submitted and approved before they unblinded. Don’t
confuse naive READERS.
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“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
Sign up for Northwest email list here (hit the subscribe to email list button in the lower right)
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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