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.
It's certainly better than nothing. Just still not quite the obvious slam dunk you'd hope to see.
Then again, given what's happening with Iovance right now, you almost can't even count on the slam dunks these days!
I have little doubt that the pandemic slowed things down quite a bit, especially in 2020. A LOT of clinics were trying their hardest to make sure that patients were coming into infusion centers as little as possible. So a speculative trial like this one was going to be hard to continue to accrue. I would be interested in asking Ram someday about what slowed it down, and whether it was related to challenges with handling the Lm stuff. I've heard similar stories about dealing with Amgen's T-VEC from other doctors.
Very hard to say! But I've been keeping an eye out for results on ADXS's various platforms, despite their penny stock status. They're still trying to accomplish something.
As much as people don't like to hear it, I'm afraid I couldn't say. I do know that several factors would be working in its favor:
1) Area of unmet need
2) Safety profile observed with Lm tech to date
3) Demonstrable efficacy (assuming that's the case)
They would need to run a confirmatory, randomized trial of some kind, but decent response rates could very well be enough to get them there. Disease control rate, to date, has not gotten any approvals that I know of, so I would like to see the response rate get a little higher in a larger study, which is totally possible.
Hey ub,
Without being able to see the data, keep in mind that these studies will often be conducted several months in advance, with a data "cutoff" that is usually pretty far back.
For example, on slides at ASCO, you'll see "data cutoff: February" or "March" rather often.
So with the March data release, we don't know when those data were gathered, and that is certainly not a formal scientific forum through which to present the data.
Long story short: March to June is ~3 months, but the time between that 67% and this 44% might be longer than that. We have no way of knowing, since the ASCO presentation is not available. No way to even guess!
More importantly, it's not so surprising with a small study to see things that look either better or worse than they actually are. It's the unfortunate byproduct of running a small study in the first place. I would take Ram's comments at face value (I've worked with him, had dinner with him; to say he's extremely sharp is an understatement of an understatement). These findings are encouraging, particularly since these are patients that already progressed on pembrolizumab and therefore had no reasonable expectation of benefiting from the pembrolizumab side of the treatment on its own.
It's a different picture from ADXS-PSA, where we don't really know how those patients would have done with pembro alone, for example.
That said, even though this is encouraging stuff, until there is a larger study to validate these findings, then they just don't know how things are going to shake out. They wouldn't need a phase 3 to get approval if the results in...say 50 or 100 patients...show the same 44% durable disease control rate. These are patients who are in serious trouble.
It would also give a better idea of the "real" response rate. 17% means 1 or 2 responses in this small study. They may have just gotten really lucky, or the other patients go unlucky. A larger study would help figure out whether it's really this low (though still better than nothing) or is actually higher.
I hope that makes a little bit of sense!
Thank you for the vote of confidence, Ig. I feel I am cautious and attempted to be balanced, while admitting my biases at the time, being a shareholder of ADXS.
While I accept that an investment decision is each person's personal responsibility, I also have regret that an investment I was publicly excited about did not work out. I have cautioned again and again against putting too much into ADXS, but I also know that I was a cheerleader. So there are mixed feelings there.
That said, the science still hasn't failed, and I'm rooting for them, even if my personal fortune wasn't made with the company.
Well, to be fair, I've had a "real" job for over a decade, if you count the sub-minimum-wage grad school work I did as a job.
I "disappeared" because I took the same advice I gave out to anyone who lost faith in the direction. It did not appear as though they would be able to solve serious cash issues any time soon, so I sold the last of my stake for $9.90 per share back in April, and unfortunately, the rest of the year has made that timing look pretty good.
I'm certainly not joining the "ADXS is run by crooks" brigade. They have a tough job to try and bring a drug to market. I still think they have a shot, but I am neither obligated nor inclined to ride that roller coaster forever.
I will say this, though: my lack of writing on sites like Seeking Alpha has stopped largely due to transitioning to a different company, one that's a lot more public-facing and concerned with possible impropriety. Therefore, I do not own and healthcare stocks now, and I have elected not to write about healthcare stocks any more.
As for the Amgen deal, my assessment of that situation was that there was a single champion for ADXS's therapy at AMGN. This can happen, and when he left, that wasn't a great sign for the deal. Furthermore, AMGN has had a LOT of success with their bispecific T-cell engagers.
Back when I made whatever exact statements I've made, it seemed like Amgen was making a decisive move toward antibody-based immunotherapy. This wasn't because of one guy leaving, per se. In retrospect, it seems more likely that he moved on because of their overall gravitation away from cell-based therapies.
Since then, they've doubled down on this kind of research. In our medical education programs, you can hear doctors debating the merits of "off-the-shelf" versus "personalized" immunotherapies (specifically in the space of myeloma and targeting BCMA with bispecifics vs CAR-T cells). So the moves Amgen has made do support a general move AWAY from cell-based therapies to pursue off-the-shelf treatment options.
Yes it is possible, but the max times to response don't usually stretch to many, many, many months or years.
Moreover, stable disease could mean the patient is staying alive, but to be unambiguous we do need to see these clinical responses, particularly CRs. Complete remissions would be the ticket to rapid approval.
Agreed, it's tough sailing, but scientifically they're not moving in incredibly unusual ways, trial-wise.
Well, there are drugs out there with only rare CRs that are nevertheless highly effective (see ibrutinib). But it takes a lot of effort to prove that right.
Almost all phase 1 trials I've seen have been tiny. There are very few exceptions to this in the hem/onc world, particularly for unproven cancer therapies.
On point 2: this is an encouraging early sign, and it tracks with about what I expected to see as far as efficacy. Tumor cell infiltration by immune cells, an early correlate that SOMETHING is going on.
The big sticker is whether observations of stable disease is going to be enough. Obviously, if you can keep a patient's cancer stable, then you've technically turned it into a chronic disease. However, in traditional therapy, stable disease generally signals that treatment has not worked, or that it is about to stop working.
Therefore, I don't view "stable disease" results as inherently negative, especially with immunotherapy. But ADXS is definitely going to have its work cut out for it when it comes to convincing others that something meaningful is going on, since they're not seeing bona fide responses (which is not surprising for a phase 1 study).
More that their cell-based therapy guy leaving corresponds to a general shift in strategy away from cell-based therapies. They're more focused on antibody-based immunotherapy, particularly their bispecifics.
I wish I knew, but it's unclear, for sure. Any number of reasons for him to leave, but I don't see it as a great sign, given how much effort he's put into this program and company.
I did opt to sell, right before the news of the dilution. I've been keeping an eye on everything, because it's still interesting to me, but I'm not sure what good I can contribute at this point, particularly with no new data emerging to discuss.
This is good news, for sure. Losing Petit was not. Hopefully they can get the ph3 rolling quickly again.
That I don't know, since it's dogs. All kinds of differences between human and animal studies
I doubt Petit is crawling on sites like that looking for opportunities. He would more likely be in touch with a head hunter if he was interested in jumping ship.
Based on what? Dew has laid out a lot of good cases for it, and he's been right more often than a lot of us.
Interesting editorial comment from Tomasz Beer, MD, re: the ADXS-PSA press release:
A badly misleading title. This study could not determine if survival is prolonged by the combination. The only thing that this trial can demonstrate is that the combination tested is tolerable and feasible. It will be interesting to see it move beyond phase I. But for now, we know it is feasible.
So at least you know people are paying attention, but we have to be careful about getting ahead of ourselves in terms of data interpretation.
I'm happy for you that you sold. Would have appreciated it if you disclosed that in a real time.
It may surprise you, but no. I haven't seen anything discouraging in the science.
However, the reality of the situation is if I stay glued to the science, and not what management is signaling to us, then I am asking for trouble. It's unfortunate that encouraging clinical research like this can be so disconnected from the business end of things.
I think they're doing what they can, but I'm not going to ask them for more punishment just to be a science zealot. This tech is worthy of a partnership, and that's probably coming at some point. I have no idea when, and I'm reasonably happy that I don't have to take a 30-50% hit to hold through the AACR news waiting for it.
I'm definitely watching. The fact that there are no warrants tied to this (unless I missed something) suggests that the price may not fall as far as we fear?
At any rate, $4 per share is where I start getting some interest back in for now. There's always the chance of a positive surprise, even now. But I'm not willing to put myself in a position where I need to count on one.
why would anyone buy stock here?
Do you really think the AACR data would have moved the share price ten-fold on its own?
The only time that happens is when a company gets a surprise, out of nowhere approval, ala something like DNDN in days of yore. It does not happen with encouraging early-stage clinical trial data. The ~60% boost we did get was about all you can hope for with these kinds of findings.
AACR gains would not have been enough to move the share price over $1, let alone for any significant period of time.
In fact, we weren't even close to pre-split $1 per share.
Context clues helped me out there, James :)
I'm only a pedant if it matters.
So median OS is always an estimate based on how the curve fits the data, and it's possible for it to be revised as new data come out.
This is one of the problems of low sample numbers, though. You can have your data skewed a lot by relatively few outliers, making the numbers less trustworthy. Personally, I would consider this the "most real" number we have for now and don't hold my breath for it to improve.
21.1 months would be an EXCELLENT number to reach on its own.
I'm in the clear as long as I don't give any information that's not public (not that I'm privy to much). And as long as I continue to convey an air of unbiased detachment, as opposed to cheerleading, then any programs I work on I can honestly say that my bias won't mess up the materials I'm developing.
It's tricky, but I feel I can honestly say I am not biased too much.
Hov, do you think this is the kind of data that would get someone at Merck excited?
They increased 36-fold to the same market cap where ADXS. We're not going to jump to $1.4 billion on similar news.
The BPTH comparisons are getting very old. They're not in the same league as ADXS.
1) Nah. Buying into a big run-up is not something I'm going to be doing. These data are definitely encouraging.
2) No; I'm breaking from Seeking Alpha indefinitely. My company was bought out by a much bigger one recently, and I have to watch that kind of conduct, at least for the time being.
No, I think a deal like that would send ADXS at least doubled from 30. A $500 million market cap post-deal would definitely be reasonable, in my mind.
The odds of that happening today are astonomically low, though
Certainly it's generating excitement, and I would say that "further exploration" of ADXS is warranted, particularly at this extremely low valuation.
I feel that the statement is boilerplate to being practically meaningless.
All it states, to me, is that they do not want to end the ADXS-PSA project, and rightly so. It does not signal that they intend to go it alone. It does not signal that they have some kind of backing.
All they're saying is "hey, there's a stop light up ahead." We don't know the color because we aren't there yet. Whether we get to the stoplight in a Kia or a Bentley remains to be determined.
Yes, it could be. And so could cervical, and so could HOT, and NEO.
It COULD have been for years now. The reality is that it hasn't been. The question is this: what is the likelihood that we see a deal struck in the next week versus an announced dilutive cash raise?
I agree; I don't think the deal is close enough to prevent a secondary. I very much hope to be wrong on that count, though
This is how they go. 37 patients is not enough to pursue approval in this setting, so the reasonable presenter of this poster is going to say "it's encouraging, and we need to know more."
If they can repeat the 21.1 months median OS in a more robust study, then you'll really have something there.
Broadly, these findings compare favorably with KEYNOTE-199, which showed median OS ranging from 7.9 to 14.1 months. (https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.7_suppl.216)
As always, we have to be very careful about making cross-trial comparisons, but this is a clearly encouraging signal that absolutely needs to be pursued further. If anything supports interest from Merck, I feel it is these data.
Hey ub,
1) I believe this is because we're in part A still, where there are only two doses being tested. In part B they're going to escalate the dose to between the 1e8 and 1e9 levels.
2) 2 discontinued likely due to their "DLT," which stands for dose-limiting toxicity. Given the patient age in those cases (75 years old), this is unfortunately probably the end of the line for them.
The third patient discontinued most likely due to their progressive disease.
3) From these data, we cannot say one way or the other. If you pair these findings with NTGN's data showing that antigen spreading seems to be required for achieving a response, then ADXS showing antigen spreading is a good sign.
It's not the end-all be-all, but the company has identified a dose where you shouldn't go, and they're ready to refine that approach and lock in a safe dose to go and test efficacy.
We CANNOT safely say that this "is far from being a cure." We do not know, and it would be highly premature to assume as such.
Thing is, this is still way too early to tell, too. It's interesting to follow, for sure, but I'm not convinced yet that there's really something here, particularly for the low, low price of many hundreds of thousands of dollars.
Certainly, these results are not on the same level as those that initially ginned up excitement for CAR-T cells in leukemia. There we saw evidence of 90%+ response rates in heavily pretreated disease.
Well, to be fair, the latest approval was for pembro, and it was the (low) response rate they were able to achieve...IN A BIOMARKER POPULATION that got it. Basically, there's a slim chance if you just give the pembro, but those odds go up a lot if the patient is PD-L1-positive.
That kind of thing the FDA likes a lot more, unless the response rate is pushing a level you can't ignore, like above, say, 35% or so
It is a good signal, for sure. Like I said, better than I expected from a phase 1 study.
My hope is that all this immune correlative data ends up translating into substantial clinical activity. But the industry is going to be in "show me" mode, I suspect.
Absolutely, these phase 1 data lay it out clearly that Amgen did not have much clinical information, good or bad, to base their decision on. It strongly supports my understanding that it's a matter of prioritization on Amgen's part.
As for Merck? We do not know the status of potential discussions. For all we know, they could announce a partnership tomorrow. I think the prostate data are hypothesis-generating, and worthy of further consideration. Repeat those results in a larger study, and you'll have a really compelling picture for ADXS-PSA.
Frankly, that's what's had my interest as far as Merck is concerned, and the other minor collaborations they're opening up with ADXS give a glimmer that there is something brewing behind the scenes.
Of course, don't get me wrong. Merck doesn't care about us in the least, and a different partner may transpire. But MRK and ADXS are definitely making interesting innuendo with these collabs.