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Hanuman, these guys are using a different method to genetically engineer the T cells for CAR T cell therapy. It looks like there is basically three differences between this group and everyone else doing CAR T therapy. They claim it's going to be cheaper and more efficient and safer? We'll see. I don't know enough about the specific methods used in CAR T cell therapy to judge.
Difference 1) they use a different method of producing the CAR gene for treatment. They use something called "polymerase chain reaction" (PCR), which is basically making a piece of DNA in a test tube. Whereas others use DNA from a crippled virus that they have to grow in cell culture and then purify from the culture. PCR is pretty simple for the most part and it's a lot faster, easier and cheaper that growing crippled virus.
Difference 2: they get the CAR gene into the T cells using electricity, which produces little pores in the cell membrane, and they use "linear DNA" to make their CAR gene- a piece of DNA with two ends, like a thread, that is produced using PCR mentioned above. Everyone else uses the crippled virus, or a circular DNA called a plasmid, to carry the CAR gene into the T cells. I'm not sure why this is an advantage. They do say they are going to look into methods other than electroporation so maybe it's not a great advantage. Also, the linear DNA might have an advantage over the crippled virus method, I'm not sure about their system specifically.
Difference 3) they use a different "DNA Cassette" to carry the CAR gene into the T cells. Every one else uses the crippled virus to carry their CAR gene into the cell where the gene get's "turned on." This group is using their linear DNA with what they call a "High Expression Amplicon (HEA)" to carry their CAR gene into the cell. This HEA is basically a signal section in the DNA that turns on the gene at a higher rate than other systems. Or at least that is the idea behind it. They say they are tinkering with it to try to get greater production of their CAR gene in T cells.
This is all to-the-best-of-my-knowledge.
Thanks for sharing your info Tripolar, it's good to hear there wasn't a flat out rejection. I understand an embargo on releasing any data to be presented, but I don't understand why there would be an embargo on notifying authors of acceptance. The ASCO site still posts March 29th. Apologies to anyone startled by my post.
Now I wonder if they will still release abstract titles online on the 17th?
From a page of quotes from "Reminiscences of a Stock Operator," by Edwin LeFevre.
"2. Learn how to sit tight
After a wild and lengthy rollercoaster ride as a speculator, Livermore believes he has found the secret to his success. It’s obvious he’s excited by this discovery, which he eagerly shares:
“After spending many years in Wall Street and after making and losing millions of dollars I want to tell you this: it never was my thinking that made the big money for me. It was always my sitting. Got that? My sitting tight!
“It is no trick at all to be right on the market,” he adds. “I’ve known many [traders] who were right at exactly the right time, and began buying or selling stocks when prices were at the very level that should show the greatest profit. And their experience invariably matched mine; that is, they made no real money out of it. [Traders] who can both be right and sit tight are uncommon. I found it one of the hardest things to learn. But it is only after a stock operator has firmly grasped this that he can make the big money.”"
I'm assuming our ASCO submission was rejected. I don't think they will put out a PR to say that, and I don't think they are required too. I don't think having an abstract submission denied is "material information" that has to be disclosed. Having the submission accepted would be information that would have to be disclosed.
So if it was rejected, I wonder why? We don't know the nature of the data or the actual submission, but it may be that the limited data they had available could not be "packaged" in an acceptable format for ASCO. For example, the following might be one reason for a rejection:
"Interim analysis of a prospective randomized clinical trial will be considered if it is performed as planned in the original protocol and is statistically valid."
(see "Abstract Eligibility" here https://meetings.asco.org/am/abstract-submission)
How many patients did we have for the data submitted? Enough to be statistically valid (p=0.05)?
To be honest, I'm sort of grasping at straws here. But I guess I'm giving our team the benefit of the doubt. We all know the quality of the people involved, and in my mind if our team is impressed enough with the data to submit it in the first place it must be good. I don't know if we'll ever find out why the submission was not accepted, which sucks a bag of dicks, but waddayagonnado?
Some shorts might make some money in the near term. I hope they buy a lobster dinner with their gains and then choke on the hors d'oeuvres just as the waiter brings the main course. And no one in the restaurant knows how to do the Heimlich maneuver.
I guess I've been patient this long, and frustrated before. But I think we are fine in the long term and that is my investment philosophy so, whatever. Fuggit.
I think the lack of a PR on ASCO is one reason we are slip slidin' away this week. They were hoping for an oral presentation and on the 29th and since we get . . . crickets? So maybe the uncertain longs, the traders and the shorts are going to provide shares for sale in the $5s again.
Wow, that was a really impressive CC. I think our team came across as very well organized with an intelligent strategic plan. I know we've been "flying under the radar," and I think we've also faced a LOT of skepticism, but I think we've hit/are hitting a pivot point in terms of recognition and credibility.
This work on pancreatic cancer is really intriguing. One of the analysts noted how their jump in enrollment in the clinical trial the past month was so impressive and rare. And IMHO to already have data you feel worthy of an oral presentation at ASCO suggests they have something special.
I really liked that immediately after the merger they had clinical trial planning meetings with former medical directors of CAR T companies and then more meetings with lead clinical PIs from transplant programs around the country.
Hopefully we get good news on the ASCO submission this week. If we do I would expect our uptrend to continue another couple bucks between now and the meeting. And depending on the results themselves, maybe we challenge last year's high.
Well this is nice.
We broke out over the 200 day EMA (we closed one penny below it yesterday) on high volume for the first time since the first week of December. The 20 day EMA crossed north of the 50 day EMA for the first time since first week of November. It was very bullish to creep up on middling-to-low volume the past two weeks and then see a high volume move with conviction to close at the high YTD. And we've now made a "higher low and higher high" since the low in December.
Traders can be a pain in the arse sometimes what with the way they can whiplash a stock, but in this case if our nice technicals attract traders and our update tomorrow night is judged good by the market, the (tons of) remaining shorts will have that much more competition on Friday. What is it, like 9 days ave. volume short? I really don't like to talk about short squeezes because then it seems you usually get a good kick in the nad$, but the next few trading days could be epic. (knock on wood).
Well at least the chart is repairing itself. Both the daily and weekly exponential moving averages are converging in this price range.
The past two weeks we crawled up through the 20 and 50 day EMAs. Now we're close to knocking on the door of the 200 day EMA currently at $6.32. And today we closed above the 20 and 50 week EMAs. It would be nice to close the week over $6.32 and start dragging those EMAs north again.
Also, if we can stay above ~$6.15 we'll have cleared the resistance zone shown on the volume-by-price chart.
daily: http://schrts.co/nHmVJeti
weekly: http://schrts.co/CKxQfKKx
volume by price:http://schrts.co/yzvfDpWY
KeithandMIC, see Phantom's post 25902 for burn rate info. Also, keep in mind we could see accelerated approval. At least one of the analysts covering MRKR thinks it is a possibility.
"Good to see your focusing on the important things though."
Dammit Phantom you made me spit coffee on my keyboard. I did have the same thought though.
In another life time I did research on transplant rejection. We were trying to put pig organs into people, to act as a bridge until a compatible human organ became available. This was a big lab at an Ivy league school and there were numerous times people in the lab were interviewed about something or another. Every time the interviews took place in a shabby back corner of one of the labs. I always had to laugh at that. I guess it was so they wouldn't get in the way of the people actually working.
I like the part near the end when he says they will have some results on solid tumors in the near future. And I like that he thinks we are undervalued. Shorty gonna find himself a day late and a dollar short soon.
There are a lot more shares held by smart institutions than there are shares short. The shorts do not know more than the longs, I'm pretty sure it's quite the opposite.
Microcapbiotech, I can definitely empathize with you. I'm mildly frustrated but I keep in mind there are some pretty sharp institutional shareholders right along side us small time geniuses :)
Also rumor has it others wanted in on the offering last spring but were turned away, and some who did get in wanted more but had to settle for what they could get.
Maybe some patient institutions are quietly buying from the overzealous shorts at these levels.
Investorcmz, I guess my thinking is that because the two approaches are so completely different we cannot draw any conclusions from their results so their results are irrelevant for us.
For example, did their p3 "fail" because of the design of the study - when, how much, how often, etc they administered the drug? Or did their drug fail because of a half dozen other reasons that may or may not he relevant for us? The possibility that FRa would not be a good target was always there, but we can't possibly know if that is why their therapy "failed," so I won't put any weight at all on their results in terms of the potential for our therapy.
One thing to keep in mind is that their PIII failed it's primary end point of Progression Free Survival, or overall survival, compared to the chemotherapy group. But does that mean their drug "failed"?
Their therapy was equal to chemotherapy in terms of those end points. But their therapy had more than twice as many patients respond compared to chemo for the group that had high FRa expression. Also the response to their drug was longer than the response to chemotherapy. So did the drug really "fail' or did they pick the wrong endpoint?
Hanuman, Immunogen's trial was testing mirvetuximab, their monoclonal antibody with a chemotherapy "poison" attached. The mechanism of action is to bind to Folate Receptor-alpha on the tumor cells and deliver the chemotherapy agent directly to the tumor cells.
So, pretty much so different from our therapy that it is more or less irrelevant IMHO.
"Should be a fun 2019" And should be a fun 2020, 2021, ... 2029,
For Christmas I had my kids (ages 20-24) start a Roth IRA and I started each of them out with shares of MRKR. It should be an educational experience for them, hopefully a long term one :D
Thanks Phantom and Llyod!
Thanks guys. Yeah I'm an air head. I looked at the NASDAQ site and it's listed right there but last night, and I was not intoxicated, I looked and did not see it.
Anyway, I think the institutional ownership summary for MRKR at the NASDAQ site is interesting. Fourteen new positions (8.7 mil shares) vs six sold out (400K shares) and Baker Brothers are the 3rd largest holder.
https://www.nasdaq.com/symbol/mrkr/institutional-holdings
Lloyd, Phantom, where did you see the filing for the Baker Brothers? TIA!
I agree with you Burrhead. But I'm also of the Anybody-but-the-patriots mindset. Great defensive game but terrible outcome. Oh well.
Please Rams. Please?
Don't laugh at my probabilities sparky! My doctor implanted an Improbability Drive in my arse and now I can pull highly precise numbers out of there any time I want.
Sparky99, I'm thinking we will fill the gap at $4.10-$4.18 left btwn May 29-30. Estimated likelyhood of 87.42% IMHO.
Re. possible merger Viracyte. It looks like they have had a lot of success doing pretty exciting anti-viral work using the same G-Rex platform that we use for T Cell activation and expansion. Right now they are focusing on treatment or prevention of a group of high-risk viral infections for people who've undergone hematopoietic stem cell transplant.
I don't see any reason they could not expand this therapy to other viral diseases, as well as other microbial (protozoan or bacterial, for example) diseases where cytotoxic T cells don't normally play a role. With Malaria for example, the plasmodium parasite inhibits dendritic(antigen-presenting) cells from activating T cells, but their/our approach does this step in tissue culture and then infuses the activated T cells back into the patient. In some bacterial infections, cytolytic T cells ferret out bacteria like MRSA that are hiding inside of the patient's cells. Viracyte's "off the shelf" T cell preps might be useful in treating MRSA infections earlier than what occurs naturally.
I wouldn't be averse to a merger. Whether or not, and when, to merge would depend on how it would be structured. As far as funding goes, Viracyte's "About" page says:
-Awarded Orphan Drug Development Grant from the FDA
-Potential for state and federal grants to accelerate development
I guess I trust our management to structure any potential merger so that it would be beneficial MRKR.
This whole week we've sat on support at the 20day EMA (@ $5.95). Got rejected at the 50 day EMA ($6.35) on Tuesday. Our chart formation is called "walk like an egyption."
To add to Phantom's post, the shares were part of a private placement to raise $70mil that went through in the 4th Q with the merger.
Peter delivers. Kickin' ass and taking names.
Excellent. There are usually several hundred poster presentations at a meeting like that and only the more interesting stuff is saved for oral presentations. Wish I could go.
Hi Flyingj. I haven't really had time yet but I did find this profile of Dr. Steven Rosenberg, the doctor in the video. It sounds like he did early work in CAR T. His clinical trials are listed on in this link:
https://ccr.cancer.gov/Surgery-Branch/steven-a-rosenberg
Flyingj it looks like the update for TPIV200 was just to show immunogenicity. I'm not sure why they added the line about the 11 of 80 patients relapsing without including any explanation or context.
Doggonit, dangnabbit. . . I hate gaps. Is anyone else superstitious about gaps having to be filled? Last May 29th we closed at $4.10, and on the 30th we gapped up, and put in a low of $4.18, leaving an 8 cent gap. So because of this superstition I was kinda glad to see us drop so low. . . but the low on this dip was, interestingly, $4.18 on Dec 24. So we traveled all the way back down here and didn't close the gap. Very close, but no cigar. Thing is it might actually be bullish that we got so close but didn't quite close it. I forget the details of this superstition.
Epicare, MRKR isn't transfecting T Cells so they express Chimeric Antigen Receptor (CAR), so we don't have a CAR T therapy. In CAR T, they take the patient's T Cells and genetically modify them so they can recognize the cancer cells. In our therapy, we activate the patient's T-Cells (or donor donor T Cells) that already naturally recognize the tumor cells.
Hi Flyingj, I think this is the video you are referring too:
Cytotoxic T Cells Killing Cancer
An interesting video:
"Seeking Alpha Expert" ??? I'm not sure what that is exactly. The author sounds like a very conservative investor.
It appears to me he gets most of his information from MRKR's website. He does not mention the transcripts from a recent meeting, or either Dr. Ann's presentation or Peter Hoang's presentation, so I think he has not done a thorough DD.
So IMHO the quality of his opinion is about as valuable as you can expect from an average-to-below average opinion featured on Seeking Alpha. There are occasional good featured reviews on SA but I don't think this is one of them.
Funny, back at the end of May when we just broke above $4, the following day we gapped up. And now here we are at just about that same point, but it doesn't look like we filled the gap.
I don't think anyone is talking about a merger. The rumor is we might do a joint venture in which case the upside would be owning some of whatever products might be produced by the partnership.
In one of his presentations he referred to them as our sister company.
4fatcat4, Like you I was concerned about what kind of effect a socialist-type health care system would have on biomedical R&D. After looking into it, I'm not concerned at all. Turns out that biomedical research is thriving in many places with socialist-type health care systems. In S.E. Asia in general, but especially in China.
If you look at tables 1 and 2 in this paper on global biomedical research trends, you can see how the US compares to countries with socialized medicine using rank in terms of quality scientific puplications, R&D spending, and the trends in both those areas.
https://df6sxcketz7bb.cloudfront.net/manuscripts/95000/95206/cache/95206.1-20170615082157-covered-253bed37ca4c1ab43d105aefdf7b5536.pdf
"Why MRKR down, when Nasdaq is up?
We are not in the Nasdaq."
We are listed on the Nasdaq. But other than that, good points!