Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I'm still hoping that they can drip it in during surgery.
Exactly. avastin is not great but nothing has been effective with rGBM so they're betting on the high failure rate.
All the short thesis that I've read is complete BS and a lot of FUD.
The one point I have seen that is the most valid is that the failure rate for rGBM is extremely high and that even the best, avastin, fails to extend OS.
Well, there's always a first for everything.
Many short sellers are betting on it to fail for rgbm. They have data and statistics on their side. But we'll see ...
No matter what happens -- up or down -- I'm waiting until 2nd half to see the interim results.
Too bad they didn't work with the European authorities to design a trial that would be independent of avastin. Would've been nice to see supporting data from Europe.
Sounds like avastin is too expensive in Europe and that the KOLs played a role in the recruitment.
Thanks for the insightful article!
Here is the full research:
http://www.jimmunol.org/content/jimmunol/198/5/2125.full.pdf
"Results were in line with our previous findings: BIO-VB-201 and BIO-VB-221
bound similarly to TLR-2, whereas MOSPD2 precipitated only with BIO-VB-201 (Fig. 1E). We therefore hypothesized that MOSPD2 promotes monocyte migration and that VB-201 may inhibit MOSPD2 function."
My take on the abstract was that they wanted to determine if MOSPD2 was plays a role in cell motility and found evidence that it does (due to inhibited phosphorylation).
That's why I said it's still very, very early. As you know, it will be years before we get solid information on something like this. But, it's good to know that they have innovative stuff in the pipeline.
1) Still in the very early stages.
2) "MOSPD2 promotes metastasis of breast cancer cells and is a potential target for the treatment of metastatic breast cancer." Obviously, this is a huge population and if VBLT can create something that prevents cancer cell motility, then all the better!
That is a nice writeup, davidal66. I agree, especially about the timing of the interim analysis -- about July to Sept would be my guess; hoping the VB-111 arm pushes it out to later.
Regarding the CLDX trial, I think the main takeaway was what CLDX did in phase 2. In phase 2, they selected patients so that their outcomes would prove favorable for CLDX. In phase 3, they couldn't do that and the truth came out.
I don't think VBLT did that for VB-111.
davidal66 ... cells (no matter mutant or not) have different surface receptors and different pathways / signaling / checkpoints so I think a combo ("cocktail") approach should be considered. Mutant cells seem to use different mechanisms to replicate and spread so attacking them from different directions would seem like a reasonable approach.
That's why I'm somewhat intrigued by VB-600 and its approach to cell motility.
Yes, I understand what you mean, and I see davidal's response and agree with it.
Patients are so much better informed nowadays -- about different treatment options and their effectiveness / symptoms -- it would be difficult to create two identical arms.
The fact that patients are turning down free avastin tells me that they're not satisfied with its effectiveness (or lack thereof) and are searching for other options.
The avastin only arm still needs enough patients to have statistically significant results, but the results will confirm what many other trials and hundreds of patients have shown: avastin is ineffective in extending OS.
"They can cherry pick the responders." .. By "they" do you mean the company or the investigators? The company is not involved in the process -- selection or delivery -- and they do not make decisions.
Are you saying that the FDA and DSMC are "cherry picking" to improve the data?
The extended survival tail is encouraging, and indicates that patients are having durable responses. Durable responses are not commonly seen with most oncology treatments, but have been a hallmark of leading immunotherapies such as Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab), and
Merck’s (NYSE: MRK) Keytruda (pembrolizumab).
http://www.baystreet.ca/articles/research_reports/lifesci/VBL022217.pdf
Prana1 ... patients on the VB-111 trial know the dosing regimen and they can tell if they're given avastin only or not. Some have left after finding out they're on the avastin-only arm.
Those are all keys stats (granted with a small population size) but very significant considering that 1) VB-111 is working in 3 different solid tumor types and 2) these patients are out of options after having been through other (failed) therapies.
Good to hear confirmation on upcoming events:
1Q17 - Full Ph2 data of VB-111 in Thyroid Cancer
2H17 - Phase 3 Pivotal study in rGBM interim analysis
2H17 - Operation of new manufacturing facility
2H17 - Launch of Ph3 trial in Ovarian Cancer
Setting the stage nicely for the March conference call.
I liked his emphasis that VB-111 improves OS in late stage solid tumors in all comers (rGBM, ovarian, thyroid ... and lung).
davidal66 ... Q4 call is in March.
I doubt this upcoming meeting will reveal anything significant enough to move the stock (hope I'm wrong!). It wouldn't surprise me if they used the presentation that was uploaded to their website back in January. Q4 call will be interesting.
Guessing ...
1) Inside information - so we'll eventually find out what it is if this is the case.
2) Stock manipulation - this stock still has a low float. Easy to manipulate so that the stock triggers a "buy signal" for those folks that rely on charts.
No significant information should be coming out until Q3 or later. If rGBM couldn't move the stock with positive results in ph2, I'm not sure how ovarian or thyroid would.
I believe you can watch it live after registering here:
https://www.veracast.com/webcasts/bio/ceoinvestor2017/76107193433.cfm
It's next week: https://ceo17.eventsbio.com/connect/search.ww
Monday, Feb 13, 9:30 AM - 10:00 AM – Duke of Windsor
Vascular Biogenics LTD
Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage 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 first-in-class, targeted anti-cancer gene-therapy agent that is positioned to treat a wide range of solid tumors. VB-111 is conveniently administered as an IV infusion once every two months. It has been observed to be well-tolerated in >170 cancer patients and we have observed its efficacy signals in an “all comers” Phase 1 trial as well as in three tumor-specific Phase 2 studies. The mechanism of VB-111 combines blockade of tumor vasculature with an anti-tumor immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the pro-angiogenic factors secreted by the tumor. VB-111 is currently being studied in a Phase 3 pivotal trial for Recurrent Glioblastoma (rGBM). The trial is being conducted under an FDA Special Protocol Assessment (SPA), and VB-111 has obtained fast track and Orphan designations.
Perhaps the January presentation will be used: http://ir.vblrx.com/phoenix.zhtml?c=253311&p=irol-presentations
In this case, maybe a repeat of the news release and really not much more. I get a feeling he's saving the meaty stuff for the quarterly conf call.
Any thoughts on what will be covered next week?
My wish list:
1) What they're doing with funds from last financing;
2) Roadmap on VB-600 series;
3) Status on VB-111
That makes sense, davidal66. The recent release on VB-600 precedes their move into deeper investigation. Looks like they're following up VB-201 with another (more promising?) atherosclerosis candidate.
Will they confirm this on the next call? Would definitely be exciting news.
Agree! Will learn more about VB-600 and also what they're going to do with the cash from the recent financing.
But overall, 2017 is trending to be a good year.
My take on VB-600 series is that they found a way to prevent certain cells (in this case, monocytes) from navigating / moving. So, it can't spread.
Sounds like they're doing research on ways to disable the tumor cells. VB-111 starves them. VB-600s may one day prevent them from spreading. Both can be applied to multiple types of cancer.
Thanks for the link. Do you know if this deck was used for a recent presentation? Perhaps an upcoming presentation?
That would be amazing if they did that. I would love to see what happens when they drip directly to the site. Hope they do some sort of communication on this.
What other virus(es) do you propose?
I believe viral vectors were being tested over 10 years ago, and adenovirus had some favorable characteristics (like being well tolerated and not integrating in the genome). Adenovirus is being used in several researches, including Ziopharm and U of Mich (https://clinicaltrials.gov/ct2/show/NCT01811992).
If anything I would like to see VB-111 dripped into a tumor during surgery (similar to Duke's modified polio virus) and see if that mode of delivery improves effectiveness.
Why is VB-111 better than current treatment options?
I like this answer:
The Fas ligand is highly expressed in non-tumoral normal tissues and the activation of Fas receptor by its ligand is associated with increase toxicities. Hepatotoxicity was observed to be bypassed by the specificity of the adenovirus modified promoter, which restricts activation of Fas pathway to angiogenic endothelial cells. The specificity is further improved as the Fas component of the transgene is activated via TNF-a ligand binding to TNFR-1 in the transgene – TNF-a is less prevalent in non-tumoral normal tissue. The transcription rate of small vasoconstriction peptide endothlin-1, which is known to aid in tumor growth and progression, is also augmented in the presence of TNF-a, which further suggests that VB-111 activity is specific to the tumor microenvironment.
VB-111’s mechanism of action is independent of tumor specific mutations, which may render it less susceptible to drug resistance.
http://blogs.shu.edu/cancer/2017/01/11/vb-111-a-novel-gene-therapeutic-agent-in-cancer-ashini-r-dias-contributor/
FWIW ... I think VBLT is more promising than ARIA. I like the way the company approaches how to tackle cancer. There is a huge unmet need. There is a large market. A lot depends on VB-111 being successful and funding future developments.
Regarding VB-111 and checkpoint inhibitor, any knowledge/guess as to which one? I'm thinking nivolumab ... but that's just wishful thinking.
=========
In addition, we intend to launch a Phase 3 pivotal study in platinum-resistant Ovarian Cancer during the second half of 2017 and are also exploring the launch of an exploratory clinical study of VB-111 in combination with a checkpoint inhibitor.
=========
Regarding the VB-600 series, I think it would be amazing if they could stop the spread of cancer by preventing it from moving. At least that's what I got from the announcement. Hoping VB-111 makes it to market just so the company has the funds to continue its research.
===========
Additional potential milestones may emerge from VBL's innovative pipeline. Our continuing research into the mechanisms of cancer biology led us to identify a cell surface protein which is involved in the motility of certain cancer cells and immune cells. Serving as the basis for VBL's "VB-600" series, our researchers have developed antibodies against this novel target, which may have potential in clinical applications. We intend to provide additional data about this target protein in first half of 2017.
===========
I love seeing news on people experiencing CRs just because there are not many options in rGBM. But unfortunately, also on fb, there was one patient that was on VB-111 / Avastin and passed away after 2 months.
AF is definitely well known in biotech (and with the traders that are active in the industry) so it wouldn't surprise me if he has some insider info. Like you said, they use him as a mouthpiece because they know he has a large audience. I don't find him credible.
Thanks for sharing the good news! I hope other patients on VB-111 are doing well.
Regarding Adam Feuerstein because his comments about VBLT have been brought up on this site ... I recently sold the last of my position on ARIA because it was acquired by Takeda for $5.2B.
The reason why I bring this guy's name up is because he's really a manipulator and says things to get clicks -- similar to click baits, similar to fake news. For years, he bashed ARIA (just like he has with VBLT), and his followers shorted the stock (often prior) to his misleading articles and tweets coming out.
If you look at the chart and the short interest on ARIA, there were many people who followed his advice ... many to their demise.
The next time you see something with his name attached to it, just remember that he likes to talk a lot .. sometimes he'll get some things right.
Here are some of the things he said about ARIA:
"FDA grants BTD to $ARIA ALK inhibitor AP26113. Hmmm. How can a me-too drug be considered breakthrough?"
FDA grants BTD to $ARIA ALK inhibitor AP26113. Hmmm. How can a me-too drug be considered breakthrough?
— Adam Feuerstein ✡️ (@adamfeuerstein) October 2, 2014
The third bullet point is certainly a teaser: "VBL's novel immune-oncology target to be disclosed during 1H 2017".
Any guesses?