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How is the vaccine self administered after the initial batch?
Gary
Mr. Bigger seems to expect data on the Keytruda trial at the beginning of next year:
T+3 years not days. T early 2020
— Michael Bigger (@biggercapital) November 27, 2022
Yes she does say that this new SPORE project is with BMS.
Also I thought I had seen these same slides somewhere and, yes it was in this video where LL also presents the Poly-ICLC combo survival data;
Doc logic, did you watch and listen to the video?
Did you also hear Dr. Liau say BMS (Bristol Meyers Squibb) around the 46:45 minute mark?
Michael Bigger
@biggercapital
Replying to @KryptyPop @PlugPowerInc
"After last victory… Our focus is on the UCLA adjuvant combo PD-1 with DC-VAX trial in the rGBM setting. T+3 mysteries unbundling soon"? ??@rago_carlo $NWBO
Michael Bigger Retweeted
Drift0r
@Drift0r
A new personalized vaccine against brain cancer successfully completed it's phase 3 trial. This vaccine is created from your own tissues & blood, and is self administered over a few years after the initial batch is made. It seems to increase lifespan post diagnosis significantly
A new personalized vaccine against brain cancer successfully completed it's phase 3 trial. This vaccine is created from your own tissues & blood, and is self administered over a few years after the initial batch is made. It seems to increase lifespan post diagnosis significantly pic.twitter.com/ALKqZsXB9c
— Drift0r (@Drift0r) November 26, 2022
Michael Bigger Retweeted
Santé Magazine
@Sante_Magazine
Santé Magazine Actu👇Glioblastome : un espoir de vaccin pour ce cancer cérébral redoutable https://t.co/eOebDER18s pic.twitter.com/0z2bla8nIv
— Santé Magazine (@Sante_Magazine) November 26, 2022
biosectinvestor,
Linda has a plan and she knows that the manipulation has limits now as many traders have had their shares go long over the course of time.
Linda uses leverage and just like BMY wasn’t willing to initially pay for Opdivo but Merck was and that allowed UCLA to advance studies with it, now it appears BMY is back in on the trifecta trial. Leverage, planning based on it and execution is what Linda does and she is quick to make adjustments when necessary ie trial shut down on recruiting and restart. This is going to be so fun to watch play out. Best wishes.
By NWBO standards the ASM was never a pressing matter. MIA, on the other hand, has been. We are past the typical MIA 90 working day decision time. Would you risk a possible negative AS raise vote outcome just because you wanted to hurry up and stick the ASM in with the AS raise vote come hell or high water? Before you knew MIA progress?
MIA could happen any day.
ATLnsider,
Always interesting to see what is not mentioned, like Poly ICLC. Seems the effort here is to focus the combo message on the major players even though more is known. Of course if survival at 10 years goes from over 50% to closer to 100% ie “tumor elimination” then there is at least a decent pretext for doing so. Best wishes.
Didn't have time to watch it yet. Though I think I've seen it already but can't remember much of it haha. Will have it a go in a bit.
Should always write everything down as there's just too much info around to remember...
Thank you for providing that link Larppis. The first link does specifically say Keytruda and Merck.
Did you watch and listen to the video? Did you also hear Dr. Liau say BMS (Bristol Meyers Squibb) around the 46:45 minute mark?
There are actually two different sites to read about the SPORE projects. On the other one they specifically mention Merck and Pembrolizumab (Keytruda), on the other one they do not.
This one has the mention:
https://trp.cancer.gov/spores/abstracts/ucla_brain.htm
This one does not:
https://cancer.ucla.edu/research/ucla-brain-spore/research-projects
Yes, here is the video link below. Go to the 46:45 minute mark.
But, I also provided the link in my original post that you replied to:
This suggests to me that NWBio may partner with Bristol Myers Squibb (BMY) instead of Merck (MRK).
Because BMY is providing some funding, and they ar providing some of the treatments (PD-1 inhibitor & CSF-1 receptor inhibitor) for the UCLA Spore project that combines DCVax-L + PD-1 inhibitor + CSF-1 receptor inhibitor. .
But, it is also possible that NWBio could also partner with both BMY and MRK.
There is only one spore combination trial of which I am aware and it includes Keytruda. Do you have a link to the video ATL. I know you’re careful, but it seems so not consistent with the clinicaltrials.gov database. So definitely want to hear that directly.
Agreed. It’s outrageous and she did not apparently do any independent work. She is taking quotes from this rando doctor who is not even vetted as such an expert that his opinion should contradict then JAMA peer review, the 70 doctors, many of them very well known and respected who are signatories thereto.
It’s more garbage. Noise generated to create controversy and readers.
I think you might be reading too much into the convos you had with DI.
Agreed that DI is top shelf, and because he is top shelf he would never under any circumstances give any investor even a whiff that there was a BO or JV on the horizon one way or the other. If a BO was lined up, him even dropping the subtlest of hints would literally risk the entire deal. For all he knows the conversation could be recorded and blasted onto twitter.
If there is a BO in the works, it is likely that only 4-5 people at NWBO know anything about it. It would be LP and a few top executives. Likely LP wouldn't have even mentioned it to DI because until they are ready to go public with it, he doesn't need to know. Billion dollar BO deals are airtight, and you better believe that any big Pharma execs entertaining such a deal would require iron clad NDAs with severe penalties for leaking info.
My suspicion for a BO/JV is as follows:
-Doesn't make sense to sit on a journal article for two months. Why would they turn down a 2 month head start on applying for regulatory approval? Only BO or JV makes any sense of that.
-If we were flying solo, LP would be asking for way more than 500mm shares. Would take at least an additional 1-2bn to get the company to a point where they were stable and profitable.
-It is now at a point where it makes financial sense for Big Pharma to BO/partner. Getting in now guarantees they'll make a nice profit off the technology, and if they wait another year NWBO gets a lot more expensive.
Also Gary, that’s not how a buyout works. You’re suggesting they’d pay 2 billion for 10%, and then what? That’s not Theo whole company. It sets a nice lowest price for a buyout valuation but for a partnership. I would not mind that, but it’s not an actual buyout. Though I could see other kinds of deals where a partnership like that could be very nice. But I still think they’d want the shares from the company and the dollars supporting the company directly, not indirectly in the secondary market for shares.
They will take it into consideration. Read footnotes in next 10Q for further info on how far up the consideration path they are at. Rumor has it they will include the term “strongly considering”. It cannot get much more serious than that… besides of course.. ya know.. actually taking legal action. But let’s not get crazy. They aren’t close to that just yet.
Re Keytruda combo trial;
After last victory… Our focus is on the UCLA adjuvant combo PD-1 with DC-VAX trial in the rGBM setting. T+3 mysteries unbundling soon? 😀@rago_carlo $NWBO
— Michael Bigger (@biggercapital) November 26, 2022
dstock07734,
Actually it can only happen when sufficient cell based manufacturing infrastructure is in place and even with money that takes time. Find out where that buildout is happening now in anticipation and you have some hints as to what direction NWBO is headed. Massive buildout plans at Memphis next year can be taken as a nice starting point. Biomarker correlations are going to make a difference as is news about the use of Poly ICLC and checkpoint inhibitors. Those who realize the only serious opportunity for a cure is utilizing these options are going to demand the opportunity in trials or outside of trials and patient advocates are going to be rather boisterous about this. Patient stories will make a big difference when they are finally shared and broadcast to a general audience as will the NWBO story which is a story I believe Linda Powers and company plan to protect and share. Once that happens then maybe more than one or two big pharmas will have a shot to partner. Best wishes.
I think it would be great for shareholders and you make great points. I just do not think and have not seen a lot of big pharma investments in tiny companies where they diverted their investment to the pockets of investors. Plus, in your scenario, the stock price goes up half as much and the other half sets the price at a fixed rate, so shareholders who do want to get out, don’t see the price they were hoping for AND half the investment gets diverted from developing the company to thousands of random people. It just seems far less productive. If they wanted to issue more shares, they could at a higher price, but giving the company double the amount ensures that the company can put that money to good use.
It’s just like with dividends and why early companies are not supposed to give dividends if they are actually a good long-term growth prospect. The money staying in the company should produce much higher returns. You give the money back to shareholders when you can’t think of a way to improve returns by investing it in the company. That would not be sending the right message.
So good points. I simply don’t agree with that kind of a deal.
I don't really take that brand of "journalism" seriously. Sadly, that's pretty much par-for-the-course-standard in American journalism these days. Looks like she read the article on STAT news and more or less copy/pasted it into her own blog. Absolutely zero research or due diligence on her part. Looks like she didn't actually read the JAMA paper (or even understands its significance), nor is she aware of the long standing feud between AF and NWBO. She is also factually inaccurate about the # of long term survivors.
A "controversy" = clickbait, so the results being questioned was likely done to drum up traffic to their site. Move along folks... pay these people no mind.
Biosect, if they did it this way they'd halve the number of shares they'd issue and those shares could be used at another time, hopefully at the higher prices that could be achieved after the partnership. It's other benefit is giving the partner a greater percentage of the company as the O/S doesn't go up nearly as much. In that I believe a fair number of shareholders will want to be out at the price a partner is willing to pay it would probably help maintain the higher price the partner agreed to purchase at.
As long as the company had the shares available for later use, I believe the billions they should receive from the partner should put them in solid financial shape. If the partner were looking for say a 20% interest in the company, and 10% of it was new shares $2 billion for that 10% share would seem to go along with the smallest numbers I've heard that LP would consider for the entire company.
Gary
I would like an opinion on this presentation that Dr. Linda Liau gave in May 2021:
This writer should be fired for this last statement alone:
This person looks like they wanted to work with AF. Who is this author to question JAMA? Unbelievable.
It’s a derivative article the inspiration being Adam.
I said no unexpected good news.
MIA approval is imminent at this point. I expect Advent could receive the license at any point between now and the end of the year, latest. And by that measure, that PR will come before the ASM seeing as it isn’t happening until after the last trading day of the year.
It wouldn’t surprise me in the slightest if that news was released next week.
I’m not forecasting any doom and gloom here. I’m also not forecasting a Reddit event. I think the company will continue progressing slow and steady, business as usual. Which isn’t a bad thing.
FeMike,
You already admitted that the 3 year forward P/E valuation discounted back to net present value is considerably low so I think it’s safe to say that if back of the napkin folks like us have figured this out then some other folks know this too.
Linda has kept this enterprise going to the point of critical mass and no return. Manufacturing gets movement. The UK wants this done so MIA approval was expected by year end. With no specific updates this remains possible unless Advent has been informed or knows otherwise which Linda would be required to disclose especially because of her interest in Advent. If this was just on NWBO then my take might be a little different. It’s not as clearly Advent and MHRA are involved. Best wishes.
There are multiple 10 year survivors in the DCVax trial. The actual doctors that participated in the study have confirmed this. I don’t know exactly how many, but I remember a bare minimum of 5 individuals that have personally expressed this testimony on social media. I would wager it’s around ~20 people if I had to guess.
And by the way, this is utterly unheard of in GBM
I wouldn't read too much into Prof. O'Rourke's opinions. Prof. Steven Brem from the same University (U Penn) who has participated in the trial speaks highly of the results.
Correction - The writer isn’t particularly inexperienced. Maybe the editor was. Here’s a link to her bio:
https://www.freethink.com/people/kristin-houser
In any case, I think we’ll catch more flies with honey than with vinegar if we can gently but firmly point out where her piece fell short.
For one thing, in reference to the long tail of survivors, she mentioned only one patient who survived 8 years or more. I can’t figure out where she got that idea.
Additionally, she wrote that patients who used DCVax actually progressed sooner than those who didn’t. At the very least, it’s much more ambiguous than that, and moreover, the overall survival is clearly better with DCVax. That is all patients care about.
Yes, that turbulent time ingrained deep in my mind. At deep emotional time, I had to tell myself to treat the investment as a donation to cancer research, if a complete failure at the end. I tell myself to think positively: at least NWBO clinical trial is my 1st choice as donation to cancer study.
Happy Holidays, everyone!
New popsci article?
Hello all, I apologize if this was already posted. I ran across an article about DCVax on my Apple News feed.
It’s haphazardly sourced and poorly written (probably by a fresh young journalist in a hurry). It also includes some inaccuracies that make the product look worse than it is. Perhaps you’d care to join me in kindly pointing out their mistakes?
The original website is Freethink.com:
https://www.freethink.com/health/brain-cancer-vaccine
They even seem to be unaware of the original JAMA Oncology paper!
if i remember rt being an old timer myself , they tried this once or twice. and they bought the price back down to nothing. just saying. Does anyone else remember that far back.
I am an old timer of NWBO, had been reading the board and following the stock since early 2012.
I'll vote YES on my family's 1MM shares. Hope the management can up-list and raise the share price through JV ASAP.
Yeah, MIA news should be any day next week. Then follow by MAA submission news sometime in December. Then ASM....
Voting yes on my 5MM+ shares as well. I always assumed we would get to 2 Billion shares before we saw a level of commercialization that would generate enough cash flow to sustain and grow the business organically. So I’m OK with 1.7 Billion. I’m hoping they have something up their sleeve to raise share price and up-list sooner than later.
Happy birthday sentiment!
I am voting yes on our 1.35mn shares as I firmly believe this management is on the right track after so many years of upheavals and forces against it in this corrupt OTC market, my first experience in it. I have been in this stock for one year, religiously reading every post, and it has been quite an education, even as I spent 15 years in emerging market equity analysis with NYSE listed shares. But even if relying on my instincts/gut feeling to some degree in terms of the science, I have very strong feeling that NWBO will turn out to be the best investment in my lifetime by a long shot.
13% comes from Kaplan Meier calculations.
It’s conditional probability that gets calculated from the first interval all the way through to the 5yr point.
not as simple as taking the number at risk at 5 years Divided by 232. You take the chance of surviving 4 years and multiply it by the probability of making it to five years if you already made it 4 years.
Looking at the treatment arm KM curve, I see 4 downward movements of the line between yr 4 and 5. Since the number at risk changes from 35 to 25 during this period, we can say 4 died and 6 were LTFU during. Under KN calculations, LTFU Numbers are normalized over that period to get the average number at risk during that period. This is often done By dividing the # LTFU in half. So the average number at risk in that period is 35 minus half of 6, which is 35 - 3 = 32. So with 4 deaths, we get 32 - 4 = 28 alive of 32 adjusted at risk. 28 / 32 = .875.
The final answer is .875 * the 4 yr survival estimate which is 15.7%. Of course this 15.7% is calculated in a similar way based on the 3 year survival probability, but i’ll take it as a given for this example.
So finally we have .875 x .157 = 13.7%
Obviously my calculation is slightly off (perhaps my LTFU adjustments or assumptions are off) since JAMA reports 13.0, but that’s the general idea.
MIA could be any day.
Lots sounds very reasonable there to me VI.
Nothing that anyone knows of.
One anonymous person started bragging about what their equally anonymous friend told them but did not disclose what that thing was.
Others picked up the theme and it became the new hope that something would happen next week and the ASM news heightened the idea.
Folks are still coming to terms with the idea that this is all we got out of JAMA/SNO and want to believe that the ASM would not be held unless something more would happen between now and then.
There are no solid indications anything big will happen next week. It’s all vague happy talk.
I’ll trust the professionals who post under their names and credentials. We can all make arguments about what we think until the cows come home. Verifiable people are more reliable. In these cases, looks likely that this was validated by more than just one person as I doubt Dr. Musella would just recklessly put out randomly false speculation of that sort. I do not have the same confidence in anonymous social media posters.
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Moderators XenaLives sentiment_stocks CaptainObvious Poor Man - Doc logic JerryCampbell |
“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.”
~ Winston Churchill
Stylized Dendritic Cell featured on NWBO board since 2015
- Dr. Linda Liau, PhD, MBA, Professor and Chair, Department of Neurosurgery, David Geffen School of Medicine at UCLA
Clinical Trials
DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer (NCT00045968) - Phase III (Double Blind)
UK (MHRA): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
DE (Germany - PEI): DCVax-L to Treat Newly Diagnosed GBM Brain Cancer (EudraCT#) 2011-001977-13
Expanded Access Protocol for GBM Patients with Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (NCT02146066) (Expanded Access)
Safety and Efficacy Study of DCVax-Direct in Solid Tumors (NCT01882946) - Phase I/Phase II (Open Label)
UK Clinical Trials - Study of a Drug (DCVax®-L) to Treat Newly Diagnosed GBM Brain Cancer
EU Clinical Trials for DCVax-L - Phase III
Dendritic Cell Vaccine for Patients with Brain Tumors (NCT01204684) - Phase II - at UCLA - Randomized (Open Label) testing DCVaccine with Resiquimod and DC Vaccination with Adjuvant polyICLC
Pembrolizumab and a Vaccine (ATL-DC) for the treatment of Surgically Accessible Recurrent Glioblastoma - Phase 1 (NCT04201873)
Dendritic Cell-Autologous Lung Tumor Vaccine (DCVax-L) and Nivolumab in Treating Patients with Recurrent Glioblastoma - Phase 2 (NCT03014804)
Dendritic Cell Therapy for Brain Metastases From Breast or Lung Cancer (NCT0368765) - Phase 1 - Collaborator: Mayo Clinic
Announcement of DCVax-L and Anti-PD-1 Monoclonal Antibody (Pembrolizumab) for Patients with Liver Metastases of Primary Colorectal Carcinoma Phase 2 Trial - November 17, 2016 - University Medical Center (UMC) of the Johannes Gutenberg University of Mainz
Cognate Bioservices - Owned by Charles River Labs
Website
Company Contact Info
Investor Relations:
Les Goldman (Company) (202) 841-7909 lgoldman@nwbio.com
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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