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2018? Take a look at clinicaltrials.gov. I see 2023 for the P3 final results.
Wow. Very disappointing non-news. SP response not in proportion to bad non news. A clue... or just shock? Or do the bigger dogs know something?
SP drop was in response to potential dilution, not shocking non-news. Why not both? Did the big dogs already know... or know something good (don't want to bait anyone). Just weird.
Once again this is getting curiouser and curiouser.
Wrong site / co / cancer therapy. Oops! Feel free to erase this post.
I like the idea of genetic patient targeting. It increases the chance of a trial success, and it is more fair to patients and competing therapies.
A year or so ago, Biogen shares/cap dropped $20B on news of their P3 Alz treatment not doing well (as I recall). The market for Alz alone is absolutely enormous, so finding a legitimate slice of that pie would be a wonderful thing for patients and investors alike.
I'm not saying this approach is not a smoke screen. It could be, but I am saying that it makes total sense and may be real. Back when I paid a lot of attention to oncology drugs/therapies, and spent a lot of time on these message boards, I pushed the ethics of target patient populations. There the subject became very complex as cancers mutate from one type to another, etc.. Maybe such will turn out to be messy here as well, and maybe not. If they came up with a significant, apriori identifiable population of Alz patients that benefits highly from 2-73 or 2-73 plus then that will be huge!!!!!!!!! And right now there is reason to hope that is exactly what is about to be announced next week.
Just want to say that I am very excited that L results are likely finally going to come in the near future. Sorry for my joke, "Stay Optuned" which I think was pretty frkn funny, but the truth is I am excited. Even broke and owning no stock, I am excited for all the right reasons and for all of you that stuck it out attempting to rally retail support. I know DCVax-L might fail, and I think everyone here knows it might fail, but if it shows efficacy, I realize, that will be huge for GBM patients, and possibly all solid tumor cancer patients in the near future.
Thanks Senti: I hope it is only if things go badly. I thinks so too, but myself, I am not 100% sure.
I have seen radical dilution at a private company using preferred shares. That may or may not have been truly necessary to entice investors to keep the company going. I think it was actually necessary. For a public company, that level of necessity might have to go under a microscope. Maybe that is the difference.
"https://www.optune.com/hcp/newly-diagnosed-glioblastoma/efficacy"
Maybe all these years LP has been trying to say "Stay Optuned!" but it just sounded too German.
8k: I wish I could hire Watson to translate, but I may have to go with Siri or Echo or... what does Amazon have?
I will read it again a few times, but dmn! I hate this stuff. I once unwound a true d-spiral (don't say the d word!) and I don't think this is such. I think this is more a safety net for recent investors in that they get everything, more or less, if DCVax fails, which is not entirely unfair. If DCVax wins... then I think the d-spiral like feeling goes away and all is well.
But I just read it once, and this is not my forte'. I just happen to have been through a real d-spiral before and I don't think this is the same kind of structure. When you start to see the phrase "cashless exercise" then you might be entering a d-spiral.
Not listed in SEC database.
How many warrants are outstanding? I don't hear people talk about warrants here, but I saw many listings of warrants being issued in their recent SEC docs. Warrants issued in the past. I don't see how many though. No way to evaluate the potential for the SP if you don't know the real fully diluted share count.
I also do not understand those recent SEC docs. They talk about shares being registered and I think they talk about shares being offered, but again, I see no numbers.
The concern would be: Why would they do significant financing in January if they thought the sp was about to soar on positive P3 data? If they were flat broke, that would make sense. But they supposedly have about $28M less expenses since last Q report. So why finance now? I can think of an excuse, but I don't want to try that hard.
Thank you me33.
Where did this rumor come from? "He transferred them to the trust." I have asked both posters on the other board where they got this info and have yet to receive a reply. I see nothing in the SEC docs... but then I often miss things.
Please show us your doodiligence.
I am a fan of this company. Just not believing this explanation.
Thank you Smokey. I will take a look this evening. Off to work.
Which SEC doc discusses Shares/$ to Cognate from NWBO?
Maybe it was in the recent settlement/finding. I read the settlement brief and did not see that discussed. Perhaps this was in the detailed settlement which was not PR'd.
Or was this in an SEC filing? I don't see it, so I am behind here. Curious just how much $ is being transferred as shares, and if the share price is a sliding one or some fixed price from yesterweek... ie 17 cents?
Just picking on you Sentiment because you are so active on the board and up on what is going on. Not really a response to your last post.
"That PR never even mentions mesenchymal. " (Not a Dupe Message)
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Your right. It only mentions methylation. I misread it somehow.
However, it worried me some when I thought it had mentioned mesenchymal. It worried me in light of the info Doc Logic just posted. If the MRI scan analysis means of detecting Mesenchymal is a recent improvement, as Doc Logic stated, and if biopsies are bad news because lack of homogeneity would force too much tumor removal, as Doc Logic stated... then things do not add up for mesenchymal detection in 2014.
But you are right. The 2014 PR does not mention mesenchymal. So this new MRI analysis could be something to argue with the regulators about. They would have to take into account your concern about the stats, but I don't believe that is necessarily a killer for that subgroup.
And if I were McCain, for instance. And I find my tumor measured to be mesenchymal via the new LL/UCLA MRI detection method, and NWBO presents stats that show, albeit a-posteriori (if that is a word) that this means DCVax-L has a good chance of giving you 5+ extra years, then I would probably insist on it. Then I would PR it all over the planet!
"That PR never even mentions mesenchymal. "
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Your right. It only mentions methylation. I misread it somehow.
Thank you Longfellow: (and Doc Logic): That PR was a very big deal yet I had forgotten much of it. Not entirely clear to me whether"controlling" mesenchymal and methylation necessarily allows subgroup SS as a fallback without a statistical threshold hit / alpha spend... but it might have been taken into account already.
Those stats on the permanent immune system damage from radiation are extremely disturbing. I am not going back on the bandwagon saying skip SOC... as I would have a couple years ago when I thought I knew by butt from..., but holy moly, 40% of patients with immune systems irreversibly destroyed... wow! Certainly begs research into any changes that might improve that stat if immunotherapies are to become part of the solution. I know there are super expensive types of radiation with far less collateral damage, but I do not remember damage to the immune system being mentioned as part of the improvement. I hope it is. Avoid penetrating the bones??? Be full of anti-oxidants during treatment so that only more directly hit areas have sufficient free-radical density to kill stuff???? Hopefully all optimized in the past, but the equations change when you add an immunotherapy.
The one part of SOC that I return to B&Ming about is using temalozine on patients/tumors that are not methylated. (I am sure not quite right usage of the term). This concern because TMZ is known to sometimes damage the immune system. But... apparently not the dominant concern regarding the immune system, and perhaps fear of inhomogeneity and real-time mutation force the hand toward usage of TMZ regardless of methylation. Or was/is it just marketing?
"getting as much tumor into lysate as possible is critical because targets are not evenly distributed in the tumor."
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I don't remember this being said but I will take your word for it. Sounds believable, but unfortunate that the distribution could be on a macro scale.
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"More recently UCLA has found a way to identify mesenchymal GBM by way of imaging so tumor loss for identification of this subtype is no longer required. Best wishes."
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They must have had some method by the 2014 trial changes PR that Longfellow reposted a few posts up the page today. A method sufficient to allow "Control". Either balancing patient types or accounting for the difference in post analysis.
Thanks for the info Doc and I will cross my fingers that the Mesenchymal MRI analysis is being allowed in the data analysis that has happened, is happening, or will soon be happening. Of course the whole ball of wax would be preferred over a subgroup approval, with the hope and expectation that it would be the start down the correct path.
What I understood Dr. Liau to be saying is that the recognized mesenchymal, classical, etc, subgroups are not able to discern in time to select a given therapy for GBM. I believe that leaves only methylated vs un-methylated. I also believe that was the only subgroup called out in advance.
I heard them say they had setup multiple ways to win, but methylated/not was the only subgroup I remember being mentioned.
Back when these things were being talked about often, the greater group learned whether methylation status (I assume of the tumor) is easily measurable in time to select a therapy. My vague recollection is that it is... but asking anyone if they remember for certain.
Does anyone know why it is (as Dr. Liau stated) that the (Mesenchymal etc.) subgroup status cannot be discerned in time to make a therapy selection?
Not saying they will not pass for all GBM in the trial, but just talking about the fall back positions not being as numerous as I had assumed for many years, according to LL's recent statements.
Exactly on all points.
McCain will almost certainly have to deal with recurrent GBM. Maybe obnoxious for him or those around him to get their sad heads spun learning the issues now... but better now than real time in crisis mode 3 or 24 months from now.
Freezing the fkng tumor should be pretty standard at this point anyway, at least short term. DCVax-L is by no means the only experimental therapy that benefits from having the tumor to study. There are scores of therapies in development and I am sure many can benefit from having the tumor frozen.
STAT article: I thought this section was informative. It explains to me why there is not more emphasis on genetic testing. I wonder if methylation is among the genetic characteristics that is considered so heterogeneous that it is not very useful to take into account during treatment. Actually... I think it is considered worth taking into account, and is therefore a useful subgroup to call out apriori (to a trial), but maybe not so useful as to gamble skipping Temador if the tumor is determined to be "not methylated".
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"The exception is if a patient’s glioblastoma is much more uniform than the norm. In that case, it is “addicted” to one specific proliferation pathway that’s vulnerable to a molecularly targeted therapy, Gilbert said. Since McCain will have access to the best care, he will presumably have his tumor genetically profiled (which costs upward of $8,000) to see if it falls into this category. With any luck, he will be in the 2 percent to 3 percent of patients with an extremely uniform glioblastoma that succumbs to a therapy that knocks out its one proliferation pathway."
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DCVax-L is, of course, better suited, in theory, to deal with the varied genetics within a tumor.
https://www.statnews.com/2017/07/21/mccain-glioblastoma-treatments/
No. Maverick stopped posting when he pulled out. Some would bash the stock after pulling out, but he just remained silent. A fair thing to do, and a sane thing to do. Others might continue saying good things about the technology (as opposed to the short term investment)... their hope to improve the odds of the trial finishing... and that too is ok in my opinion, quite noble, but certainly ok to just bow out of the discussion as you wait for a re-entry point, as Maverick did.
Very sad news. I like the man. Sounds like they are taking GBM very lightly. "Completely resected"... the blood clot? Not the gioblastoma I don't think.
Chemo and radiation? Works great... except that it destroys your immune system and you are almost certain to die soon anyway. So... maybe he should look around for further treatment options so supplement the SOC.
Tweet this: If it is not methylated (60% chance) then don't use the Temador which can damage the immune system. And don't dispose of the tumor... or put it in wax, freeze it. You can put the blood clot in wax, but freeze the tumor.
Maybe they are acting like it is no big deal for N. Korea's sake.
Yes, that was biobrooklyn. Sorry about that BioAddict. And let me not throw water on the heat.
Never mind...
3.5M shares outstanding and a single day trading volume of 9.5M. Whassup?
"AVII - reasoning - a SWARM of pseudoprogressors got in (my language)"
1) I recently asked AVII his opinion on the scenario where PFS fails but OS wins. I wasn't asking that because I thought PFS failed.
2) If there were a swarm of pseudoprogressors, then they were likely induced by DCVax-L soon after treatment. If so, it would be a mistake to characterize them as having slipped through the screening. But such could certainly give PFS a false failure if they are mistaken as true progressors. The post analysis, however, would be very interesting. One would see any such mistaken progressors from the treatment group with super long OS. That would beg consideration... beyond beg.
3) Due to circumstances beyond my self-control I am currently quite poor. For that reason I am not all-in. For that reason it pains me to post anything positive. So... I will not do so often until I hit the Lotto. That said, I am not at all sure that DCVax-L will prove out. I just think the risk-reward is very compelling, and the story and potential in the medical sense are compelling. But then I was a cheerleader here for years before becoming a broken mute so of course I want this trial to end well.
AVII: What is your opinion for the opposite scenario where the primary, PFS, is negative, but the secondary, OS, is positive?
I can't do this kind of trial modeling, but did try to get the Celdex/Rentiga data to compare to your modeling a while ago. Could not find PFS info. Frustrating. Glad to have that verified.
Maybe they foresaw this situation right here and wanted the advantage of knowing their PFS stats?
Or maybe their PFS efficacy was negative. If even a little negative they may not want to air it, and could get away with it since it was not the primary enpoint.
A) Public Eats Private = Public?
or
B) Private Eats Public = Private?
Which makes more sense?
Which seems more likely?
You are assuming "A".
I hope you are right.
I have just been hovering around Maverick. I am not in, but curious. I did see the Marcum plans. I would be more positive on the possibilities but the move to preferred shares scares me. I worked at a company where all the employees had their common shares obliterated at the snap of a finger, 8:1, while the preferred shares were untouched. That was a private company though.
I see you around and read your posts when I come across them. I loom in the background these days... careful with my tiny wad. Options discovered me about 9 months ago, and they like me very much. Wish I felt the same about them.
WT%#*@&? They just diluted 60% or something like that, and with preferred shares. I guess I am missing something. I thought preferred shares give the company the ability to destroy the common shares down the road and preserve the preferred shares... something like that.
So they dilute 60% and setup for worse down the road and the share price jumps 20%. Dang!!!!!!!!! I guess I don't get this stock market stuff.
$1000/share was for preferred shares which are worth over 1000 of your stinky common shares guys. Maybe that is the misread here... or I am misunderstanding something, which happens a lot.
Killer DC's: Doc Logic:
(googled this and saw a little about what you are talking about)
If the DC's know (statistically) who to kill with their interferon etc... then maybe they know who to get antigen from? That would increase their efficiency in useful antigen gathering above the purely random across all tissues. (even if they still don't know a neo-antigen from a self antigen)
The cytokine environment tells them, this is a place to fumigate? The cytokine environment also tells them this is a good place to gather antigens?
Yes. I agree. Could be funded trial for Direct or positive results anticipated for L. Many CI combo trials do not get funding from the BP source... but some do. Leans toward positive L results. Further, not all indications for Direct-2 will have the CI option, so that too reduces chances of that trial being funded... making the alter explanation more likely.
They have all details about individual patient age and health, etc. They have the ability to model the expected mOS and mPFS for the blended group using that information. So even with the enrollment details now in our hands, they know better just how special these results (probably) are... or not. So such foreshadowing as you reference does have meaning.
Although volume always picks up leading into ASCO, people are usually disappointed and volume drops after. Not just for NWBO, but in general. Just saying that might not be the case for NWBO this time because there was substance in the presentation.
If volume picks up you can't just credit ASCO, you would have to credit what they presented at ASCO. One of the biggest complaints about NWBO has been the lack of any trial data for a very long time now. Yesterday they gave a great deal of L trial data and some important information about future plans for Direct.
There is light at the end of the tunnel!
Your estimates of blended mOS and mPFS sound great to me. I know you and others have done a lot of work modeling these things. Sounds like you were very close in all your estimates.
But to what extent do you discount this projected gain in blended efficacy over historical, due to enrollment/continuation criterion for DCVax-L? I am sure you and AVII (as well as RK and others) have debated the issue. Did you ever come to any consensus? How many months of blended efficacy would AVII likely attribute to the trial design?
Since there is a potential net dampening in spirit here I will counter with a more positive issue. The fact that they are talking about Direct with a CI for some cancers is very good news to me. If real, and I chose to believe it is real, then it means that there is no plan for Cognate to steal Direct from dying NWBO. (Direct + a CI makes a lot of sense to me.)
Maybe your right about the patient not having an option upon crossover.
Sorry if that is the case. For me that would be good news. I do want VB-111 to work.
I just re-read the official PR from the company and it doesn't say that the patients had a choice after progression. I will look around to see if it was another publication that said that, but until I find something I will assume I was wrong. Which again... is good news to me.
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June 1, 2015
VBL Therapeutics Reports Updated Interim Results From Phase 2 Clinical Trial of VB-111 in Recurrent Glioblastoma (rGBM)
Data Demonstrate Strengthened Overall Survival Benefit in Patients Treated With VB-111 in Combination With Bevacizumab
TEL AVIV, Israel, June 1, 2015 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq:VBLT), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, today announced updated interim results from its ongoing Phase 2 study of VB-111 in patients with recurrent glioblastoma (rGBM). Data showed a statistically significant overall survival benefit in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin®) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone (p=0.05). These study results will be presented in greater detail at VBL’s Analyst and Investor Meeting today, Monday, June 1, 2015, in conjunction with the 2015 American Society for Cancer Oncology (ASCO) Annual Meeting.
“We are very pleased to see a statistically significant overall survival benefit in this more mature data set, with median overall survival extended to 16 months in patients receiving VB-111 followed by VB-111 in combination with bevacizumab,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “We also announced data on Saturday demonstrating VB-111’s potential as a treatment for Müllerian cancer; taken together we have increasing confidence in the potential of VB-111 as a treatment for numerous solid tumor indications. We look forward to expeditiously continuing our development of the compound and initiating a pivotal Phase 3 study in rGBM later this year.”
“rGBM is a devastating illness and there is a clear need for new medications that effectively hinder tumor growth and extend patient survival,” said principal investigatorAndrew Brenner, MD, PhD, Clinical Investigator, Cancer Therapy and Research Center,University of Texas Health Science Center San Antonio. “These clinical data are encouraging, both in VB-111’s impact on overall survival and in VB-111’s possible role as an immune response modulator. We hope that VB-111 will play an important role in bringing the promise of a new treatment option closer to the many patients suffering from this devastating disease.”
These interim Phase 2 results include 46 patients with rGBM treated with VB-111; upon disease progression, 23 patients were treated with VB-111 in combination with bevacizumab, and 22 received bevacizumab alone. One patient remains stable on VB-111 alone at 18 months. VB-111 in combination with bevacizumab demonstrated significant improvement in overall survival, with median overall survival of 16 months, compared to eight months in patients on VB-111 followed by bevacizumab alone (p=0.05). VB-111 also demonstrated a statistically significant improvement over the historical bevacizumab data set from the BELOB trial, which looked at efficacy of bevacizumab, lomustine or a combination of both agents, and reported a median overall survival of eight months for bevacizumab in 50 patients with rGBM (p=0.003)1. Consistent with its mode of action, which in rGBM may require more than several weeks to demonstrate clinical effects, VB-111 did not affect time to first progression.
These data also suggest that VB-111 induces an immuno-therapeutic effect. Of the 46 patients who received VB-111, 25 patients spiked a fever post-dosing of VB-111 at least once, while 21 patients did not. Feverish patients demonstrated a median overall survival of 16 months, compared to non-feverish patients, who had a median overall survival of 8.5 months (p=0.03). This correlation between clinical efficacy and fever suggests that VB-111 can induce an immune response in patients and supports a role of the immune system as part of VB-111’s mechanism of action. It also strengthens VB-111 preclinical findings, which showed an elevated immune response in tumors of VB-111-treated animals.
VBL’s pivotal Phase 3 clinical trial will be led by Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and is expected to initiate in mid-2015 under a special protocol assessment granted by the FDA. The FDA has also approved the comparability of VB-111 batches produced in a scaled-up production process intended for Phase 3 and commercial production to the small scale production batches used for the Phase 1 and 2 clinical studies. Following this approval, VBL intends to use the scaled-up batches for the upcoming rGBM pivotal Phase 3 study.
On Saturday, VBL announced that positive preliminary results from an investigator-initiated, Phase 1/2a trial of multiple dose VB-111 in recurrent platinum-resistant Müllerian-Ovarian cancer were presented by Richard T. Penson, MD, MRCP, Associate Professor of Medicine, Harvard Medical School, Clinical Director of Medical Gynecologic Oncology, Massachusetts General Hospital, at the 2015 ASCO Annual Meeting. The data demonstrated promising evidence of clinical benefit in patients with recurrent platinum-resistant Müllerian cancer who received VB-111 in conjunction with weekly paclitaxel.
Study Details:
The Phase 2 trial is a multi-center study designed to determine the safety, tolerability and efficacy of VB-111 in patients with rGBM. In the first stage of the study, patients were treated with VB-111 alone. Upon disease progression — defined according to the Response Assessment in Neuro-Oncology (RANO) criteria as a worsening of the patient’s cancer with an increase of at least 25% in the overall mass of measurable tumors, the appearance of new tumors, the worsening of non-measurable tumors since the beginning of treatment, a need for increased dose of corticosteroids, or clinical deterioration — patients entered the second stage of the study, in which they received either bevacizumab alone as standard of care or bevacizumab in combination with VB-111.
Investor Event and Webcast:
VBL will host a live event with audio webcast of its discussion of the Company’s clinical programs and pipeline at the ASCO Annual Meeting on Monday, June 1, 2015 at 6:30am CT (7:30am ET).
The webcast will be available in the Events section under the Investor Relations section of the Company’s website at www.vblrx.com and an archived replay of the webcast will be available for 30 days after the presentation.
About VB-111:
VB-111 is a novel, intravenously-administered, anti-angiogenic agent that utilizes VBL’s proprietary Vascular Targeting System (VTS™) to target endothelial cells in the tumor vasculature for cancer therapy. VB-111 contains a non-replicating adenovirus, a proprietary modified murine pre-proendothelin promoter (PPE-1-3x) and a Fas-Chimera transgene which is specifically activated in angiogenic tumor blood vessels, leading to their apoptosis. VB-111 is the first agent based on transcriptional targeting of tumor endothelium to be assessed in a clinical trial.
VB-111 completed a Phase 1/2 “all-comers” clinical trial, which demonstrated multiple cases of objective tumor response and disease control and excellent safety and tolerability. VB-111 has Fast Track Designation for recurrent glioblastoma in the U.S. and orphan drug status for glioblastoma in both the U.S. and EU. VBL is also conducting early Phase 2 study in ovarian cancer.
About VBL:
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for cancer. The Company’s lead oncology product candidate, VB-111, is a gene-based biologic that is initially being developed for recurrent glioblastoma, or rGBM, an aggressive form of brain cancer. VB-111 has received orphan drug designation in both the United States and Europe and was granted Fast Track designation by the FDA for prolongation of survival in patients with glioblastoma that has recurred following treatment with standard chemotherapy and radiation. VBL Therapeutics expects to begin the pivotal Phase 3 clinical trial of VB-111 in rGBM in mid-2015, under a special protocol assessment granted by the FDA.
Forward-Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and the risk that historical clinical trial results may not be predictive of future trial results. In particular, results from our proposed pivotal Phase 3 clinical trial of VB-111 in rGBM may not support approval of VB-111 for marketing in the United States, notwithstanding the positive results seen in our current clinical trial. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
1 Taal et al., Lancet Oncol. 2014 Aug;15(9):943-53.
CONTACT: Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200, hannahd@sternir.com
As a true immunotherapy, VB-111, if effective, would likely be used in immunotherapy cocktails. In this case in cocktails for many indications.
Most chemotherapies work by chocking both the good and bad cells and hoping that the cancer dies before the good cells. It sometimes does because cancer is already more stressed due to vascularization not keeping up with cell growth, and metabolism being pushed to the limits. So adding a second effective chemotherapy is not necessarily an improvement because you are already dosing to the brink of cell death for the normal cells.
But you can keep adding immunotherapies to a cocktail if they individually do not harm the patient. Very different from a chemotherapy. Maybe less $ per indication, but these cocktails may become pervasive across many indications and their true value could be far higher than the chemotherapies if they combine to effect a cure where chemotherapy only prolonged life while reducing quality of life.
If VB-111 is effective and has no side effects.