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When would I need an administrative extension?
This approach is appropriate if a delay occurs for reasons you cannot anticipate or control, the reasons have been adequately addressed, and the clinical trial remains a high priority for NIAID.
You may be eligible for a noncompetitive extension if you have resolved delays associated with the following reasons:
Difficulties obtaining suitable study agent.
Difficulties meeting enrollment schedule.
Difficulties obtaining assurances and certifications.
Difficulties with access to suitable facilities.
External hold ups at regulatory or funding agencies (not related to safety).
Litigation involving any of the above.
Changes in public health policy or standards of care.
Are there circumstances when an administrative extension would not be appropriate?
Yes. Administrative extensions do not support extension of clinical trials due to the following types of delays:
Natural disasters or declared emergencies (NIH will address these situations).
Safety concerns.
Persistent systemic problems.
Suspension of grant activities.
Vandalism or other isolated events unrelated to the trial.
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Note 1) I doubt covid19 would be a problem since patient enrollment would have been over long ago, but even if it was it would fall under the national disaster clause I imagine. 2) this is for the NHI link in my previous post - I didn't see anything for the FDA and do not have time or concern enough to dig for it now.
Extension of Investigator-Initiated Clinical Trials Question and Answers
More than likely they want to continue monitoring for longer term survival/impact.
A smallpox vaccine? Sounds about right... MRKR working on a disease that was declared eradicated in 1980
All I really remember is imagining what I saw on Gilligan's Island:)
But I know (mrkr researcher's and mgmt) frustration is several orders of magnitude greater than ours.
A smallpox vaccine? Sounds about right... MRKR working on a disease that was declared eradicated in 1980
Honestly Micro any money spent has to be justified. There are audits when you work with grant money.
We used to run to Home Depot to get tubing for some of our precision lab equipment and had to have a half dozen forms signed in triplicate, almost, to get voucher.
I've done work in immunology, but I am not by any stretch of any kind an expert in immunology. I understand the science fairly well and as much as I like the science, I like the management and how they operate as well or better. ~Believe it ~ or not.
Seriously, I was a moment ago surprised when I saw the price. I guess I know what their days are really like and I know no one is fucking off. I know the frustration of being a shareholder and feeling like a mushroom. But I know their frustration is several orders of magnitude greater than ours.
I only hope that they DO have valid reasons for the $ spent
The point. I forgot
The extra space might be for research. There is intense competition for lab space at any university research center, maybe much more so at medical research centers bc of the major $$$ involved.
Universal Rule #2: There is never enough lab space. (#1 is Never Enough Resources in general ($$$, lab space, equipment and instruments and good admin, good lab techs, etc.).
They might have several large (and maybe multiple) dedicated rooms for things like:
1) Radioactive material use, storage & disposal,
2 Multiple for sterile cell culture. Different types of rooms for both incubation rooms and sterile lab bench work for manipulating cells. And both of those are either dedicated for patient's Multi- TAA T cell prep and supply, and for general research - and for specialized research e.g containment if using pathogens.
3) equipment and instruments (cell counters, microscopes, chemical storage and prep rooms, fridges and freezer, chromatography rooms, molecular biology equipment, autoclave room, this could go on forever . . .)
4) Offices for The Elite Most High
5) Admin space - rooms for offices, copiers, waiting room, etc
6. Offices for post-docs
7) Offices for medical residents doing research rotations
8) Offices for graduate students
9) offices for medical students doing research rotations
10) Offices for lab technicians
10 1/2) offices for Very Lucky undergrads (broom closet with bunk desks)
11) Lab wash room - usually several, one with an industrial washer
That's about it I think. My vague Ball park estimate.
Alright, this time w/o the drugs . . .
WHY would they build out a structure that is 4 or 5 times bigger than it would appear that they need.
WHY would they build out a structure that is 4 or 5 times bigger than it would appear that they need.
I'm glad you got a chuckle, it beats crying in our soup.
I said we shareholders are not going to be aware of the more or less day-to-day of preliminary and clinical research (or admin work).
If I ran the labs I'd have everyone log into the web site and have a page where they say what they did that day. I'd tell them to have fun with it but be discreet. Then have it reviewed and posted so shareholders could have a glimpse into their world.
Not really. I wouldn't do that. It's a little Orwellian and it'd drive everyone nuts.
Gitta, ok, so
"Baylor" is doing the research for Multi-TAA and they are the research team for MRKR. So MRKR personnel are doing the ongoing research and clinical trials.
Mayo is for the Tapimmune legacy vaccines and afaik and are not directly tied to MRKR corporate afaik. But
I think you might not have an appreciation for what goes into the process of working with the FDA, planning and setting up the new MRKR Corp building being leased, recruiting and organizing clinical trial, and continuing any and all ongoing research in the lab.
For example, they might be working at the bench on polystart, or consider what went into forming the modifications to the clinical protocol, etc (there are sooo many "etc, etc" in research). There are Always loose ends to be followed up on and new avenues being explored in preliminary research that we shareholders are not goin to be aware of.
I promise you no one is standing around surfing the web all day on their phones, or golfing with Trump and the ShadyDeals Resort.
I'm not a philanthropist (full on rapist) either. But this is the nature of the beast. It is what it is in terms of communication with shareholders.
Now I gotta git :)
"Patience is a virtue, I have none of either."
We shareholders in up to our eyeballs.
The company has lots of high priced talent and I often wonder how any or all fill there day... research done by others.. few calls, few tasks
I'm guessing it was sufficient to announce the hold itself to satisfy disclosure.
In a way that made me feel a little better, like it was not a really significant hurdle. I figured if it was a major problem they would have had to disclose more details.
How about a cool girl? In a discussion on Reddit a woman going for her PhD in Statistics complained that STEM programs tend to "assimilate" women (and minorities???) as opposed to "integrate" them.
Specifically she brought up an example where some STEM friends were ridiculing a "sparkly pink" microscope. She said that she is a "girly-girl" and that as a child she would have loved and been drawn to the sparkly pink microscope. So maybe she would have fell in love with math and science sooner if she had come across one as a young child.
The point being integrate by inclusion, not by forcing people to fit a mold.
But still, nothing wrong with a hot girl. We do not want to discriminate against them for being.
F'k'n Peter. I bet that lazy asshole is home sleeping about now.
Seriously though, some day we better find out what the mysterious reagent was and why it suddenly became so mysterious after how many phase 1 clinical trials where the only difference really is the peptide fucking antigens (correct me if I'm wrong).
I've been having different dreams and this same guy shows up. 1950s-looking guy with horned rim glasses and a lab coat that says "FDfuckinA" on it in big bold red letters, shaking this little brown bottle back and forth and he just tips his head like he's asking me either what I think is in it, or he's teasing me like, "See??? Want some?" But I can't see any expression on that face I desperately want to punch so I don't know how to answer him.
Really??? Come on, guys get serious. Fatcat reading your first sentence I immediately thought, "Thank you, jhc, ffs." Then I got to the Borat, "NOT!" And it was his voice I read that with, so I did get a chuckle, which made the rest of your rant kinda funny too.
So thanks I guess.
Excellent! But it looks like the beatings will continue until morale improves.
Autism is the best known irrational fear of Antivaxxers but it's much more complicated than that. Fear and distrust of vaccinations have been around starting in the late 1700s. Jefferson and Washington loved vaccines and Washington made vaccination mandatory for the continental army - the first mass immunization. By the 1820s a number of states made vaccination mandatory.
The main reasons for antivax beliefs are:
1. Distrust of medical community (esp. big pharma);
2. Belief in "alternative medicine" by the aged-urine and colloidal silver drinking, crystal-hugging dingbats of the homeopathy crowd ("yogurt cures HPV" - I assume eating the yogurt - also check out "GOOP" by some idiot former celebrity of some kind);
3. Safety and ethical/morality concerns like the irrational fear of thimerosal and antiabortionist's fear of using vaccines made by cell lines which were started decades ago using aborted-fetal cells;
3. Conspiracy wingnuts that think the government and all of the world's medical scientists and practitioners are in a conspiracy together faking various health issues including well known diseases (polio was a hoax . . . jfc smdh).
The scariest thing about antivaxxers is that it is growing among young people (29 and under). We are failing miserably as a society in terms of raising intellectually competent adults capable of critical thinking.
And antivaxxers used to be primarily the poor (<$25k annual income) and poorly educated, but has grown - thanks to the internet and our mildly retarded population and culture - and now includes a lot of well-off, college educated yuppies who with a little knowledge do a lot of damage.
Just a joke micro. I do wonder though how many antivaxers would refuse a vaccine-based therapy if they got cancer. My uncle was a life-long member of religion that forbids anything medical involving blood or blood products. When his wife developed a rare blood disease that required blood products from healthy donors they left the religion. She's been good to go for about 5 years now.
Oh I forgot. They might Not inject a microchip to follow fucking wingnuts around to see how often they masturbate. So they could publish the daily average in their obituaries. They probably won't do this. At least not for our tumor vaccines.
Both the old TPIV and new MRKR therapies are vaccines. They both use pieces of tumor protein as the antigen to immunize the immune cells.
For TPIV, they injected the tumor peptide vaccine into the patients, just like traditional vaccines for microbes and what-not.
MRKR therapies incubate the tumor peptides with Tcells and some dendritic cell that acts as an antigen presenting cell. So this is in vitro, but it's still a vaccine.
I would guess "operational" means they can produce patient T-cells, and/or peptide antigens. Maybe they'll make their own IL-2 or whatever the mysterious reagent is that the FDA put the hold on.
The out-dated clinical trials home page is maybe a good sign. They're too busy and forgot. But seriously we should all e-mail them a reminder. Maybe en masse we'll get their attention.
About the Ferrari, Magic 8-ball says, "Do DMT, Ask Entity."
I might have been thinking of this round table discussion at Evercore's HealthCare Conference last December with three other cell-therapy company CEOs.
Peter discussed (at ~14:05) the complexity of preparing to commercialize. Like scaling up an academic, lab bench-scale process to commercial scale processess; appropriate workflow for a production volume change from 100's of patients in late-stage clinical trials to 1000s or 10s-of-thousands of patients in commercial setting; commercial physical infrastructure requirements, etc.
Based on their executive's and advisor's real-world experiences with how rapidly you can get through clinical trials, and with how difficult it is to change protocols once you've entered late-stage clinical trials, they feel it is better to start commercial planning now so they are not stuck later with a sub-optimal protocol.
Because of the overall success in the blood cancer trials alone, they are starting to think and plan commercial production years earlier than they expected too, just two years ago.
So good I guess.
It seems like I vaguely recall Peter talking about this at a round table discussion last year (fall?), or maybe at an investor presentation/conference.
Something along the lines that at some point they would have to consider in-house synthesis of reagents etc, to gear up for commercial production.
Like I say, I vaguely remember it and could be wrong. I really do not remember any timeline, so I do not know if this announcement is in sync with any long term plans or if the decision was precipitated by something else, and so this build is happening earlier than expected.
It seems like they would only do this if they had a lot of confidence in the therapy's success still at this time. Planning for this is one thing, the decision to execute and commit these resources now is another.
Well turns out your opinion is a damn good one. But I don't think you need to label it a conspiracy :)
And luckily for us Texas COVID cases are increasing nicely (/s). . . I hope it doesn't delay Baylor's MFG facilities opening. And I hope it doesn't affect enrollment and initiation of the safety portion of the trial.
Impact of COVID-19 on oncology clinical trials
"The COVID-19 pandemic is disrupting clinical research in much of the world. To understand how the crisis is affecting the management of ongoing oncology clinical trials and the planning of future trials, we used a combination of surveys and interviews of oncology clinical investigators globally and analyses of data from IQVIA and ClinicalTrials.gov on oncology clinical trials to investigate challenges, risks and contingencies. Here, we present data and insights from this investigation in the hope that they could be useful to those involved in oncology clinical trials."
(check out the graphs Fig 1)
Why do you need a conspiracy theory? And what is the fact you say you base it on?
Do you think they are lying when they say we have an FDA Hold on our AML clinical trial due to forces beyond our control, and that Baylor's Mfg GMP Facilities are shut down until fall (they make one or more of our "study drugs")?
Isn't that a pretty good explanation?
(is baylor in on this, and the fda - they saw this coming last fall?!?!!! Shhh!)
I totally agree especially with the IPOs.
Our equivalent of an IPO (more like rebirth, or recovery from a NDE), might be considered June 2018, with the merger.
One thing about those IPOs, so many will be in a honeymoon period that will give way to the "show me" period. It's like the Eagles' song, "New Kid in Town."
After the Honeymoon, they'll look like us for a while - like a turd that refuses to go down when you flush - until they're successful (or finally go down the drain).
(JK about the MRKR being like a turd part, sort of. But that seems to be the market's attitude toward us right now, what with the short interest and all.)
We're stuck in the Show Me period. We're like the thoroughly used and abused Wall Flower/thot watching from afar the Virgin's at the start of their Honeymoons. Bitches.
I find that thinking mean things about them makes me feel a little better about myself sometimes.
That's what I was thinking for a long time.
But honestly, I think we are in for one of those once roughly every 100 Years Wallops in the markets.
I feel that vertigo of a fear of heights when looking at the chart of the Dow since the Great Depression - a Great Wave peak?
And we printed and borrowed since the Dotcom bust, into the Great Recession, and have since piled on record levels of debt - IIRC the Fed is at record levels of assets on the Feds balance sheet?
And the Fed says it will buy everything.
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And I think we are kind of at a major Inflection Point in history.
IIRC one of the military generals the other day said the very Age of Reason (or Enlightenment??) is at stake. It sounds like hyperbole, but he wasn't exaggerating for effect at all. And tbh I agree. I don't expect catastrophic failures or anything like that, just a Long Emergency (to steal a term from someone).
I think about these three quotes a lot lately:
If a nation expects to be ignorant and free, it expects what never was and never will be.
~ Jefferson/Reagan blend
And Arthur C Clarks "any technology advanced enough will appear as magic" (paraphrase).
And "There is a cult of ignorance in the United States nurtured by the false notion that Democracy means that "My ignorance is as good as your knowledge" by Isaac Asimov. (also paraphrased)
Yup. This I think this ends well. Noooot.
This might be a good time to take a chance on "missing out" for a little while I think.
Very interesting, thanks micro, that makes a lot of sense.
So "don't fight the fed." Especiall when they are frightened.
And a flight out of cash - and into the maw of a Giant Kodiak Bear just out of hibernation after the longest bull market in USA history.
What? Me worry?
I still would expect more of a flight to safety if anything over the course of the year for this to be sustainable. I wonder about "animal spirits" when looking at airlines and the nasdaq.
I wonder how probable it is that the bond and equity markets in the USA could see a large outflow of money if international investors get spooked enough?
Considering 1) as you said, the possibility of the USA pulling out of the UN and 2) uncertainty concerning the election security and contested results, and possible "issues" with the transfer of power if Biden won, 3) COVID and 4) Yellow Stone Super Volcano erupts . . .
Yeah. The Gods must be crazy.
Ok, I stand corrected on the Nasdaq close (but I bet Willis shit himself, so I call no harm, no foul). I looked at an hours old chart.
But still.
I. do. not. for one minute trust the Nas when most other indexes look pensive to me.
I bet the Transports is all "hot air" lines. I bet they puke blood later this year - I do not want that, I just think the market is on drugs.
I bet Dow 12k-14k bottom before this mess is "over" (whatever that might mean).
Does anybody else smell a sort of blow-off top today in the markets?
Anyone? Bueller?
I haven't done any big analysis or anything and I haven't really been keeping up enough to have a strong opinion either way, butt fuck this seems EERIE to me.
Just skipping through the major indices it looks like the markets are going to be Very, Very technically challenged starting next week.
Also, I do not trust the Nasdaq one bit. Is it really 13 points - yes Willis thirteen fucking points and a black cat's whisker - away from new all-time highs??? It made a new intra-day high but, no cigar for the new all-time high at the close???
Yeah, right. Is this market on crack? Maybe I am too pessimistic and skeptical? (I'm not cynical at all, I think the next 50 years looks gorgeous in most every way nationally and internationally).
I've been a gold bug forever (not a nutcase one, just a fan) but I suspect it too will get rejected and not make a new high anytime soon.
Thing is, 90% of the time I find I am 180 degrees from accurate when it comes to TA.
However, to me, the next 12 months look like they could be pretty chaotic.
Is the market overlooking COVID, or correctly gauging the likelyhood and impact of a second wave this summer/fall?
Who will be president 12 months from now and also will it be contested or disrupted or who knows what. I not mean to get political, just gauging possible uncertainties.
OTOH, markets climb a wall of worry?
And other cliches? lol
So, I'm a frowning, bespectacled skeptic.
There is lots of competition out there in the world of immunology,
When I was a kid, in the spring when the snow was melting and the snowbanks were like ten times bigger than the are now, we raced stick boats in the river running through ice caves to the gutter. I feel like my stick is stuck in one of those fucking ice caves.
I did NOOOOOOOOOT like our . . . indefinite (?) plans for pancreatic phase 1/2.
JFxukingC. I should post that cat-fail-jump gif again. Seriously though WTF was that all about ???
But I really do like the therapy and I really like the price and safety and multiple cancer applications.
If someone eats our lunch, I'll console myself with the comfort of knowing our therapy would still be extremely helpful in third world countries where they cannot afford major $$$techoimmunotherapies$$$.
Drown it with brown, and with an illegal smile.
What color is the sky in your world Willis? It sounds like a very mysterious and scary place. A whimpers and whines, moans and groans, and lots of gnashing of teeth kind of place.
What exactly do you not like about the timing of the offering? I'd love to know what it looks like from your world.
I think the Purchase Agreement with Aspire was outstanding. Funding of any amount we want up to $30M, at any time we want for over two years, no warrants, no derivatives or other bullshit strings attached. It's just sitting their just in case. And considering the economy, not to mention the political environment it's nice to have that ace in the hole. Who knows what happens to the venture capital markets over the next two-and-a-half years of uncertainty.
And the timing could not have been better. At the very early stages of a pandemic, just before the market pukes blood, a FDA Hold on our AML clinical trial due to forces beyond our control, and Baylor's Mfg GMP Facilities shut down until fall.
To get that funding with those terms under these circumstances is genius.
So, what exactly do you not like about it again? Other than your mysterious forces engineering run-ups and other gibberish? Do you even understand how companies operate, or how markets work? And again, the color of the sky in your world is what?
Cool, thanks PL!
I trust our science team so I am confident they know best and the following is mostly just to share anxiety with the board.
For pancreatic, I feel more and more they should take the time to do a P1 with an optimized TAA-peptide mix, and then do a P2.
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I also think/wonder if they are considering switching the chemo adjuvent from FOLFIRINOX to FOLFIRI for maintanance.
FOLFIRI = FOLFIRINOX minus the oxaliplatin, (to reduce peripheral neurotoxicity).
"Since 2011, the FOLFIRINOX regimen is recommended and widely used as first-line treatment for patients with inoperable PDA . . . with a median progression-free survival (PFS) of 6.4 months . . ."
(Their's is a similar patient population: patients with histologically confirmed, nonresectable PDA, but as young as 37yo (range 37 to 74 years, median 60.5 years).)
Adjuvent Folfuri: Folfirinox first-line to Modified Folfirinox for Adjuvent maintanance:
The median PFS under FOLFIRINOX and subsequent FOLFIRI maintenance was 11 months. Overall, 4 (18%) patients developed adverse events higher than grade 2 on FOLFIRI.
Side Effects:
Overall, 4 (18%) patients developed adverse events higher than grade 2 on FOLFIRI. Hematologic side effects were the most common with both neutropenia and anemia in 14% of the patients. In 6 patients, a protocol modification with dose reduction to 75% or interval prolongation to 21 days was necessary.
I agree Mgmt is good, except maybe in terms of their current mental health, which I imagine is being tested by the stress of dealing with the Hold and Covid delays.
I like your points. And I know they are plenty busy even with these delays (or maybe more-so).
And Mgmt seems to still have confidence in the results:
". . . if continue to see same pattern with all 15 patients, will consider a Randomized Trial as Pivotal Study" ((3Dec19 Piper Jaffray).
And now with 6(?) months more data looking forward to Phase 1/2,
"“With a growing body of data, we continue to be encouraged . . . While these results represent a small patient population, we look forward to generating additional data that may support MultiTAA’s future development . . ." (29May20 ASCO PR)
IMHO, our results are really Very impressive.
Recall last December Peter said, "at month 9 . . . more than half patients should be progressing."
And so far we have had 10 of 13 make it to and beyond month 9, and of these 2 are still progression free (1 CR, 1 SD).
Peter also said, "at this point (9 mo) more than half should be a mortality event."
And updated we still have only a 23% (3 of 13) mortality rate.
And again, it's striking 1 CR happened at all, and more so because didn't developed until month 9, suggesting it was not the chemo alone that did it.
And that 6 patients had a reduction in tumor size is an "exceedingly unusual event - growth under chemo should never reverse with continued chemo alone."
-----------------------------------
At this time, eye-balling it, our Mean PFS of ~11.8mo vs 6.4 mo SOC seems outstanding. Note this includes Patients 7&10, who are both still Stable, not progressing yet.
Our PFS is higher than the Mean Overall Survival of 11.1 mo for SOC. (slide 7).
As of Latest data:
Poster alone:
* 4 objective responses - 1 CR, 4 PR
* 2 still on-study - Patient #7= CR, and Patient #10=Stable Disease
* 6 reached Stable disease
* 10 progressive disease, continued to be followed for overall survival.
* 3 died
Changes since 21Jul19:
1. Patient 11 added had Stable Disease, but died (now 3 patients died).
2. Patient 12 added had PR but has since relapsed.
3. Patient 13 added but had no response/progressive disease.
3. Two patients are still "on study" (green) for Progression Free Survival
a. Patient 7: Complete Response for 20 months now
b. Patient 10: Stable Disease 12 months, from "too early to evaluate."
------------------------------
I think The Market under-appreciates our results. I think it's important to remember we are dealing with patients with more advanced disease and yet our patients are doing significantly better than the broader population:
Slide 8: Eligible Patients can have locally advanced unresectable or metastatic cancer:
All evaluable patients in (Arm A) have metastatic disease, except for patient #9 (who has locally advanced disease)
Now look at slide 5, Overall Survival. Where half the patients are dead with Folfirinox, half our patients are still Progression Free and only ~23% died.
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American Cancer Society Jan 8, 2020
Survival Rates for Pancreatic Cancer
The SEER database tracks 5-year relative survival rates for pancreatic cancer in the United States, based on how far the cancer has spread. The SEER database, however, does not group cancers by AJCC TNM stages (stage 1, stage 2, stage 3, etc.). Instead, it groups cancers into
Localized, regional, and distant stages:
Regional: The cancer has spread from the pancreas to nearby structures or lymph nodes. (~ Stage 2)
Distant[/b[: The cancer has spread to distant parts of the body such as the lungs, liver or bones. = (~ Metastatic Stage 3/4)
Do you or anyone remember if anyone said the hold affects all of the studies? I don't recall if that was addressed directly and I think I just assumed that was the case since the tumor antigen pepmix is the only thing unique to each TAA treatment. But I guess I should not assume.
So The Good, The Bad and The Ugly, as usual with any small biotech.
Our Chart since early March: mrkr.exe failed to load.
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A. So the Pancreatic trial is delayed until next fall due to issues beyond our control(?):
1) FDA Hold, due to original manufacture's snafu, (?) and
2) Covid, which is delaying the response by the New manufacturer to the FDA-Hold on the reagent, and which is also causing the closure of the Mfg facilities at Baylor, which is our current source for production of "study drug supply."
And this is causing Enrollment to be Discontinued for now bc patients need to start Multi-TAA ~3mo after the start of chemo. So no reagents or Mfg facilities, no Multi-TAA T-Cell soup for you.
It is good to hear the team "remain optimistic that once we are able to open the study, there will be significant patient interest."
B. Phase 1, Arm A: Yaaay, FULL ENROLLMENT (sorta).
"Expect full enrollment (15 patients) by end of year"- by Jan 2020 ( see Dec 3 Piper Jaffray conference). This was the goal for the original Group A cohort in the original Phase 1, Filing.
Time fliess, I've gotta go so I'm leaving these links here for later:
ASCO May 29, 2020 PR for Presentation:
https://www.markertherapeutics.com/2020/05/marker-therapeutics-reports-interim-results-of-its-multitaa-specific-t-cell-therapy-in-patients-with-pancreatic-adenocarcinoma-at-the-2020-american-society-of-clinical-oncology-asco-virtual-annual-m/?utm_source=getresponse&utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D
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ASCO May 29, 2020 Poster Presentation:
https://www.markertherapeutics.com/wp-content/uploads/2020/05/TACTOPS-poster-2020-ASCO.pdf
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Q1 2020 CC:
https://seekingalpha.com/article/4346342-marker-therapeutics-inc-mrkr-ceo-peter-hoang-on-q1-2020-results-earnings-call-transcript?utm_medium=email&utm_source=seeking_alpha&mail_subject=mrkr-marker-therapeutics-inc-mrkr-ceo-peter-hoang-on-q1-2020-results-earnings-call-transcript&utm_campaign=rta-stock-article&utm_content=link-2
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Dec 3, 2019 Piper Jaffray Med Conference - my post with notes and link.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153200625
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MRKR Original July 17, 2019 Pancreatic Cancer Data - PDF:https://www.markertherapeutics.com/wp-content/uploads/2019/07/TACTOPS-Investor-Presentation-FINAL-7-21-19-PDF.pdf )
Well Gatta, at least the day ended better than it could have, considering the meeting this morning.
I don't blame you your frustration, especially with what you've been through. I was on board for the last reverse split. I think 2015 was my first buy iirc.
As for communication, I wonder why they are not more forthcoming about the specifics of the reagent in question. Maybe divulging more would threaten national security or something.
wtfwk.
Every time I see your alias I think, "Ya gotta Regatta," which was the slogan to draw students to the boat races when I was an undergrad.
Fond, if blurry, memories.
I think MRKR should consider doing a booster vaccination post-transfusion maybe using a method similar to this one developed by this lab at MIT.
(note: I promise the folks at MRKR and Baylor knew about this work long before it was published. Just an FYI, so don't bother sending them this link.)
Note we infuse 100-500x as many T-cells as they did in their work below, but still I think a booster vaccination to further stimulate the Multi-TAA T cells in vivo at some point post-infusion would be worth looking at.
New vaccine strategy boosts T-cell therapy
Super-charging a treatment for leukemia also makes it effective on solid tumors
In a study of mice, the researchers found that they could completely eliminate solid tumors in 60 percent of the animals that were given T-cell therapy along with the booster vaccination. Engineered T cells on their own had almost no effect.
"By adding the vaccine, a CAR-T cell treatment which had no impact on survival can be amplified to give a complete response in more than half of the animals,"
. . . The MIT team . . . could deliver vaccines more effectively to the lymph nodes by linking them to a fatty molecule called a lipid tail. . .
In addition to the lipid tail, the vaccine contains an antigen that stimulates the CAR-T cells once they reach the lymph nodes.
In tests in mice . . . given about 50,000 CAR-T cells but no vaccine, the CAR-T cells were nearly undetectable in the animals' bloodstream.
In contrast, when the booster vaccine was given the day after the T-cell infusion, and again a week later, CAR-T cells expanded until they made up 65 percent of the animals' total T cell population, two weeks after treatment.
--------------
original paper
Enhanced CAR–T cell activity against solid tumors by vaccine boosting through the chimeric receptor
https://science.sciencemag.org/content/365/6449/162
Honestly Micro I think the CAR labs are likely barely aware of us and do not likely feel threatened by our Multi-TAA technology.
As for the Mystery, maybe we need Scooby Doo and those meddling kids.
I know components of the the T cell culture medium have to be traceable back to their source and the supplier has a Drug Master File for the FDA to review. Anything from humans or animals - like blood serum used in culture media - would need to be tested for the presence of viruses.
But they only mentioned the recombinant cytokine in use "for well over a decade" and that almost has to be IL2. And the "fragments and residual solvents" has to be the Multi-TAA for the vaccine. Neither of which should be difficult to get from multiple sources.
And in the Q1 CC they only spoke of "the reagent" - so apparently only one of the above is still in limbo (delay in getting info from new supplier to satisfy FDA to lift the hold).
The only thing I can think of is the supplier for changed something in their protocol, or let their certification for the reagent expire or something relatively stupid like that.
In the end I get the impression it is a formality and should not be a problem. But that is what I felt when the Hold was issued, and of course our supplier apparently screwed the pooch or something.
I guess for now I blame the supplier and hold MRKR mostly blameless in the absence of incriminating evidence to the contrary.
Still, fuckitty fuck fuck.